- Email: [email protected]
Weight Gain, Related Concerns, and Treatment Outcomes Among Adolescent Smokers Enrolled in Cessation Treatment
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Weight Gain, Related Concerns, and Treatment Outcomes Among Adolescent Smokers Enrolled in Cessation Treatment Elissa Thorner-Bantug, MHS; Maria Jaszyna-Gasior, MD, PhD; Jennifer R. Schroeder, PhD; Charles C. Collins, BS; Eric T. Moolchan, MD
Funding/Support: This study was supported in full by funds from the National Institutes of Health, National Institute on Drug Abuse, Intramural Research Program. We examined associations of weight concerns and weight gain with adolescent tobacco cessation treatment and whether these effects differed by gender or ethnoracial group. Participants were 115 urban adolescents recruited for a randomized clinical trial of nicotine replacement therapy. Baseline weight gain concerns were assessed using the Eating Disorders module from the Diagnostic Interview for the Child and Adolescent (DICA-IV). The average weight gain during the trial was 0.59 ± 2.85 kg among the 43.5% of participants who completed the treatment study. As indicated by the DICA, baseline weight gain concerns were not associated with weight gain during treatment, study completion, or abstinence from smoking at 3-month posttreatment follow-up; these results did not vary by gender or ethnoracial group. Adolescents who quit smoking gained no more weight during the trial than those who smoked. Keywords: children/adolescents n tobacco n body weight n prevention n treatment J Natl Med Assoc. 2009;101:1009-1014 Author Affiliations: Department of Health and Human Resources, National Institutes of Health, National Institute on Drug Abuse–Intramural Research Program, Biomedical Research Center, Baltimore, Maryland. Dr Moolchan is currently at Alkermes Inc, Cambridge, Massachusetts. Corresponding Author: Eric Moolchan, MD, Medical Director, Clinical Science, Alkermes Inc, 88 Sidney St, Cambridge, MA 02139 ([email protected]).
Introduction
L
ately, the pressure to lose weight and become physically fit has become more of a cultural norm in our society. As a result, a relationship between fear of gaining weight and tobacco cessation has been well documented in adult studies and has sparked concern among the general public. Tobacco use is the number 1 preventable cause of chronic disease and death under-
JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
scoring the urgency of addressing smoking cessation among adolescents before they become regular smoking adults. Smoking initiation, delay in cessation treatment, and relapse to smoking after quitting have all been linked to a fear of weight gain among both men and women.1-3 Because a subset of smokers may defer seeking cessation treatment for fear of weight gain,4 fear of weight gain may delay cessation and thus expose the smoker to accruing risk of morbidity and premature death. Studies examining postcessation weight gain in adult samples have consistently demonstrated weight gain in the first few months post cessation. Sorensen and Pechacek reported that women were less likely than men to engage in quitting and attributed this difference to fear of weight gain.5 Moreover, a 2001 US surgeon general’s report concluded weight gain was almost 3 times more likely to cause relapse in women compared to men (20% vs 7%).6 From 15 prospective epidemiological studies of postcessation weight gain, an average gain of 1.82 to 3.64 kg was found among adults, regardless of gender, smoking history, or cessation modality.7 In addition, a 2007 study conducted by the University of Michigan found that women who smoke tend to be further from their self-identified ideal body image and more prone to dieting and bingeing behaviors, compared to nonsmokers.8 Concerns about weight are also prevalent among adolescents and associated with smoking and cessation behaviors. In a sample of adolescent high school students, Rosen and Gross found that two-thirds of girls and one-half of all boys were tying to modify their weight.9 Among adolescent girls, tobacco smoking has been well documented as a weight loss modality.2,10 Apprehension about weight gain has been prospectively associated with outcomes in cessation studies among adolescents, suggesting adolescents who smoke may also fear weight gain upon cessation and, therefore, delay or decline tobacco cessation treatment.11 In the United States, fear of weight gain and actual postcessation weight gain has been demonstrated to deter youth from maintaining abstinence from smoking, particularly for adolescent girls as compared to boys.12,13 VOL. 101, NO. 10, OCTOBER 2009 1009
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In addition to the impact of gender, weight concerns also seem to be influenced by race and ethnicity. Important differences in the degree of concerns pertaining to weight gain (hereafters “weight concerns”) seem to follow cultural and ethnic norms in the United States. Compared with the general US population, being overweight has been shown to be more socially acceptable within African American culture.14 Furthermore, Caucasian girls more frequently report smoking to lose weight compared to Caucasian boys, African American boys, or African American girls, and smoking as a weight loss modality was highly related to race among girls.15 Thus, a substantial body of research suggests fear of weight gain may deter or at least delay cessation, and smokers who fear weight gain may be less successful at cessation. We examined the frequency of weight concerns in adolescents enrolled in a 3-month clinical trial for smoking cessation to determine whether pretreatment weight concerns were associated with weight change during the study, completion of treatment, or successful abstinence from smoking at the 3-month follow-up visit (6 months after the quit date). This population of adolescent regular daily smokers is important to study because they are at high health risk and stand to gain the most benefit from quitting compared to less heavy smokers. Analyses were done for the whole sample then separately for boys and girls to determine if any associations between weight concerns and cessation outcomes varied by gender. For girls only, analyses were then done separately for African Americans and Caucasians to determine whether associations between weight concerns and cessation outcomes varied by ethnicity among these adolescents.
Methods
institute review board (IRB). All participants who called were interviewed by trained research staff. Those who prequalified for the trial based on the telephone interview were invited to the clinic, where a detailed medical history and physical examination were obtained, along with other clinical and psychosocial assessments by a multidisciplinary team of physicians, physician assistants, social workers, psychologists, nurses, and bachelor-level research assistants. The risks and benefits of the treatment study were explained, and adolescent participants’ assent and parental/guardian permission (consent) were obtained. In order to qualify for the treatment study, candidates were required to smoke a minimum of 10 cigarettes per day and score at least 5 out of 10 on the Fagerström Test for Nicotine Dependence (FTND).16 The FTND is a reliable and validated instrument for determining level of tobacco dependence and predicts outcome with cessation treatment among adult smokers.17 Exclusion criteria for this study included recent use of NRT or buproprion, untreated acute psychiatric disorders, drug or alcohol dependence (other than nicotine), and pregnancy. Qualified participants were randomized to receive NRT patch with placebo gum, NRT gum with placebo patch, or placebo gum and placebo patch. All study participants attended group cognitive behavioral therapy led by a trained social worker.18 While advising participants to adopt a healthy lifestyle, including maintaining an appropriate caloric intake and healthy activities, the cognitive behavioral therapy did not specifically instruct participants in any particular food intake monitoring, diet, or exercise program. Treatment was provided for 12 weeks; a follow-up visit was scheduled 3 months after the end of treatment.
Subjects
Measures
Participants recruited for this study were 13- to 17 year-old volunteers who resided in the Baltimore, Maryland, metropolitan area. Youths responded via telephone to advertisements for a smoking cessation treatment trial that employed both pharmacological (random assignment to a nicotine replacement therapy [NRT] group patch, gum, or placebo) and cognitive behavioral group therapy to quit smoking. This study was advertised through a variety of media, including radio, television, word-of-mouth, clinical referrals, and print. Despite Baltimore city’s predominant African American population, outreach efforts included ethnically targeted radio station advertisements and other community channels (eg, schools, churches). All cessation trial participants who had complete data sets for the variables of interest were included in this analysis.
Ethnicities were determined by self-report. All participants underwent a detailed physical examination during which baseline height and weight were obtained. Weight was measured at each study visit, and height was assessed at the beginning and end of treatment. Weight change during the study was calculated as weight during the final study visit minus initial weight. Concerns regarding weight and body image were assessed prior to treatment using the eating disorders module from the Diagnostic Interview for Children and Adolescents (DICA-IV), a semistructured interview instrument based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition).19 The DICAIV eating disorders module is a reliable and validated instrument for clinical and epidemiological use in eating disorders in multiethnic adolescent samples.20 A participant was considered having weight concerns if he or she endorsed any of the 7 questions from the DICA regarding weight concerns (Box). Treatment outcome measures for this analysis were weight change during the
Procedures The treatment protocol was approved by the National Institute on Drug Abuse Intramural Research Program 1010 JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
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study, both absolute (final weight – initial weight) and relative (percent change: 100 × (final weight – initial weight) / initial weight); trial retention, both study completion and total number of days in the study; and abstinence from smoking at 3 months post treatment (ie, selfreport of no smoking during the 3 months after study completion and confirmed expired carbon monoxide concentration ≤ 6 parts per million at the 3-month follow-up visit). Participants who dropped out of the study prior to the 3-month follow-up visit were assumed to be smoking.
Statistical Analysis This was a secondary analysis and no separate power analysis dictated the sample size. The sample size was determined by the power calculation for the clinical trial, and all participants with the variables of interest were entered into the analysis. c2 Tests were used to determine associations of weight concerns with gender and ethnicity (African Americans vs Caucasians) for girls only due to the small number of boys in this sample (n = 11) who indicated weight concerns. Two-sample t tests were performed to determine whether having weight concerns was associated with weight change during the study (both absolute and relative). Survival analysis assessed the association between weight concerns and study retention; both log-rank and Wilcoxon tests were performed due to their complementary nature (the log-rank test is more sensitive to later differences in survival curves, while the Wilcoxon is more sensitive to earlier differences). c2 Tests were used to determine whether having weight concerns was associated with study completion (operationalized as missing fewer than 3 clinic weekly visits and attending the end-of-treatment and 3month follow-up) and with abstinence from smoking at the 3s-month follow-up visit. Fisher’s exact tests were substituted for c2 tests if low cell sizes violated assumptions necessary for the c2 test to be valid. To determine whether relationships differed by gender and ethnicity, all analyses that assessed the association between weight concerns and study outcomes (retention, completion, weight gain, cessation) were done separately by gender, and ethnicity for girls only. The type I error rate was established at p = .05. All analyses were done using SAS version 8.2 (SAS Institute, Cary, North Carolina).
Results Participant Characteristics Figure 1 provides a diagram detailing how we arrived at the analyzable cohort. Of the 120 adolescents who participated in the smoking cessation trial, 5 had missing data on weight concerns. Thus, 115 participants were included in this analysis. Participants were 15.2 ± 1.3 years of age on average. The sample was 70.4% female, and 71.3% self-reported Caucasian ethnicity. Other groups included 23.5% (19/81) African American, 1.2% (1 of 81) Native American, and 1.2% (1 of 81) of mixed ethnicity. At enrollment, our sample had been smoking for 3.9 ± 2.0 years and averaged 18.6 ± 8.5 cigarettes per day with an FTND score of 7.0 ± 1.3 (out of a maximum score of 10), indicating high dependence. The mean body mass index was slightly above the national average and was 25.3 ± 6.3 kg/m2 for the study population. From this sample, 66.1% (76 of 115) were randomized to receive active NRT (patch or gum). Assignment to treatment arm was not significantly associated with baseline weight concerns, weight change during the study, retention time, or abstinence from smoking, so it was not a potential confounder in the relationships between baseline weight concerns and treatment outcomes. More than half (61 of 115, 53.0%) of the sample endorsed at least 1 weight concern at baseline. Endorsement of at least 1 weight concern was significantly more common among girls when compared to boys (61.7% vs 32.4%, p = .004). In addition, there were significantly more girls than boys who agreed with the statement, “Have you ever thought you were too fat when people said you were too thin?” (34.6% vs 8.8%, p = .0045).
Association of Weight Concerns With Study Outcomes in the Full Sample Participants who indicated baseline weight concerns gained slightly more weight during the study than participants who did not (0.84 ± 0.35 kg vs 0.30 ± 0.42 kg), but this difference was not statistically significant (p =.33). Baseline weight concerns were also not significantly associated with study completion rate (41.0% vs 46.3%, p = .57); median retention time (42 days vs 56 days, p = .27 log rank, p = .14 Wilcoxon); or abstinence from smoking at 3 months post treatment (11.5% vs 11.1%, p > .99) (Table 1).
Box. Questions Assessing Weight Concerns From the Diagnostic Interview for Children and Adolescents Do you spend a lot of time trying to lose weight by dieting? Have you ever thought you were too fat even though people said you were too thin? Have you ever gone on any eating binges? Did you try to keep from gaining weight by taking laxatives or diuretics? Did you make yourself throw up to keep from gaining weight? Did you exercise a lot to keep your weight down? Did you worry a lot about gaining weight?
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Association of Weight Concerns With Study Outcomes Assessed Separately by Gender
casians than African American girls (68.3% vs 36.8%; c2 = 6.0, p = .014). Caucasian girls endorsed 3 individual items more frequently than African Americans: “Do you spend a lot of time trying to lose weight by dieting?” (50.0% vs 21.1%, c2 = 4.93, p = .026), “Do you exercise a lot to keep your weight down?” (36.7% vs 5.3%, c2 = 6.90, p = .0086), and “Did you worry a lot about gaining weight?” (21.7% vs 0%, Fisher’s exact p = .031). As was seen in the subgroup analyses by gender, endorsement of baseline weight concerns was not associated with study outcomes, and this lack of association was evident for both Caucasian and African American girls. Ethnicity did not modify the effect of baseline weight concerns on weight gain during the study, study completion rate, retention time, or abstinence from smoking at 3 months post treatment (Table 3).
As was true for the full sample, endorsement of baseline weight concerns was not associated with study outcomes for either girls or boys. Table 2 provides the results of this stratified analysis, which includes group differences (weight concerns vs no weight concerns) and associated p values presented separately by gender.
Association of Weight Concerns With Study Outcomes Assessed Separately by Ethnicity for Girls
This analysis was limited to 79 girls who were either African American (n = 19) or Caucasian (n = 60); 2 girls of other ethnicity were excluded from these comparisons. Endorsement of at least 1 of the weight concern questions was significantly more common among CauFigure 1. Participant Enrollment
Eligible per Phone Screen 329
Failed to Show
Consented to Study
170
159 Randomized
Ineligible 39
120
22 - Psychiatric problems 9 - Medical problems Study Sample 115
Incomplete Questionnaires 5
4 - Substance abuse/dependence 2 - Attempting to conceive 2 - Failed to return
Table 1. Association of Weight Concerns With Study Outcomes in the Full Sample (N = 115)a-d Outcome Measures Weight change during study Absoluteb Relativec Study completion rate (%) Median study retention (days) Abstinenced
Weight Concerns (N = 61)
No Weight Concerns (N = 54)
0.84 ± 0.35 kg 1.09 ± 0.50% 41.0% 42 days
0.30 ± 0.42 kg 0.33 ± 0.57% 46.3% 56 days
11.5%
11.1%
P Value t = –0.99, p = .33 t = –1.00, p = .32 c2 = 0.33, p = .57 Log rank p = .27 Wilcoxon p = .14 Fisher’s exact p > .99
a
Outcome measures were available for all participants with the exception of weight change.
b
F inal minus initial weight. Data available were for 59 participants with weight concerns and for 52 participants without weight concerns (111 total).
c
ercent change. Data available were for 59 participants with weight concerns and for 52 participants without weight concerns (111 P total).
d
Defined as no tobacco use at the 3-month follow-up visit.
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Discussion
This study examined several relationships between pretreatment weight concerns, weight gain during treatment, and treatment outcomes among a multiethnic group of teenage smokers enrolled in a smoking cessation trial. Our results do not support that concerns regarding weight are associated with weight gain during cessation treatment or poorer treatment outcome. Moreover, in contrast to adult cessation studies,5 weight gain during smoking cessation treatment was not associated with posttreatment abstinence. The limitations of these findings must be considered when interpreting our results. First, this sample of heavysmoking treatment-seeking adolescents is not likely to be representative of all adolescent smokers attempting to quit. The inclusion was set at a minimum of 10 ciga-
rettes per day to ensure an acceptable risk-benefit ratio for the administration of NRT to this young population. Also, this study was started in 1999, when the few programs that offered cessation for adolescents were research based. Therefore, we likely oversampled very heavy smokers (the most motivated and urgently in need of intervention). The lack of statistical power also precludes definitive conclusions regarding the impact of gender and race/ethnicity on the relationship between weight concerns and smoking cessation outcome. Also, the DICA questions that elicited differences between Caucasians and African Americans might have partially reflected differences in the social perceptions of being overweight, and further studies using culturally sensitive instruments are thus warranted. Finally, the large variability in the mean weight change (among ethnoracial
Table 2. Weight Concerns and Abstinence by Gender (N = 81 Girls, N = 34 Boys)a Weight Concerns No Weight Concerns Gender (N = 50 Girls, N = 11 Boys) (N = 31 Girls, N = 23 Boys) P Value Girls 10% 9.5% p > .99 Boys 18.8% 11.1% p = .65 Study completion rates, % Girls 40% 38.1% c2 = 0.024, p = .88 Various Outcomes Abstinence rates, %
Median retention time, d
Weight change, kgb
Boys Girls
62.5% 42
44.4% 42
Boys
168
56
Girls Boys
0.59 ± 0.27 1.86 ± 0.82
–0.05 ± 0.36 0.09 ± 1.18
c2 = 1.11, p = .29 Log rank p = .89 Wilcoxon p = .67 Log rank p = .32 Wilcoxon p = .38 t = 1.21 p = .23 t = –1.26 p = .22
a
Outcome measures were available for all participants with the exception of weight change.
b
F inal minus initial weight. Data available were for 78 girls (48 with and 30 without weight concerns) and 33 boys (11 with and 22 without weight concerns).
Table 3. Weight Concerns and Study Outcome Measures at 6 Months (3 Months’ Posttreatment Followup) by Ethnicity Among 79 Girls (N = 19 African American, N = 60 Caucasians)a,b
Outcome Abstinence, % Study completion, %
Ethnicity African American Caucasian African American Caucasian
Median retention time, d
African American Caucasian
Weight change, kgb
African American Caucasian
Weight Concerns (N = 7 African Americans, N = 41 Caucasians) 20%
No Weight Concerns (N = 12 African Americans, N = 19 Caucasians) 11.1%
P Value p > .99
8.3% 40%
8.3% 33.3%
p > .99 Fisher’s exact p > .99
39.6%
41.7%
Fisher’s exact p > .99
42
35
42
49
–0.64 ± 0.91
–0.14 ± 0.50
Log rank p = .87 Wilcoxon p = .97 Log rank p = .71 Wilcoxon p = .58 t = 0.45 p = .66
0.86 ± 0.32
.05 ± 0.55
t = –1.26 p = .21
a
Outcome measures were available for all participants with the exception of weight change.
b
F inal minus initial weight. Data available were for all African American girls (7 with and 12 without weight concerns) and 57 Caucasian girls (39 with and 18 without weight concerns).
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and gender subgroups) may have obscured the relationships between weight change and relevant variables. Future studies should strive to obtain larger samples of adolescents to provide more conclusive evidence of the relationships between weight gain, weight concerns, and adolescent smoking cessation. Despite its limitations, this study offers preliminary evidence that weight concerns, though common, might not be substantially associated with cessation outcome for adolescents engaged in treatment. The average weight gain during this study was small, and was not associated with tobacco abstinence. While larger studies are needed to more thoroughly study these relationships, our findings might potentially allay concerns that weight gain during a cessation attempt is inevitable, and encourage adolescents who desire to quit smoking not to defer cessation treatment due to concerns about weight gain.
REFERENCES
1. Pomerleau CS, Ehrlich E, Tate JC, et al. The female weight-control smoker: a profile. J Subst Abuse. 1993;5:391-400. 2. Weekley CK, Klesges RC, Reylea G. Smoking as a weight-control strategy and its relationship to smoking status. Addict Behav. 1992;17:259-271. 3. Orleans CT, Schoenbach VJ, Wagner EH, et al. Self-help quit smoking interventions: effects of self-help materials, social support instructions, and telephone counseling. J Consult Clin Psychol. 1991;59:439-448. 4. Prochaska, JO, Velicer, WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997;12:38-48. 5. Sorensen G, Pechacek TF. Attitudes toward smoking cessation among men and women. J Behav Med. 1987;10:129-137. 6. Public Health Service; 2001. Women and Smoking: A report of the Surgeon. MMWR Recomm Rep. 2002;51:1-13.
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7. The Health Consequences of Smoking: Nicotine Addiction. Washington, DC: Government Printing Office; 1988. US Dept. of Health and Human Services publication NIH 88-8406. 8. Pomerleau CS, Saules K. Body image, body satisfaction, and eating patterns in normal-weight and overweight/obese women current smokers and never-smokers. Addict Behav. 2007;32:2329-2334. 9. Rosen JC, Gross J. Prevalence of weight reducing and weight gaining in adolescent girls and boys. Health Psychol. 1987;6:131-147. 10. Page RM, Gold RS. Assessing gender differences in college cigarette smoking intenders and nonintenders. J Sch Health. 1983;53:531-535. 11. Klesges RC, Somes G, Pascale RW, et al. Knowledge and beliefs regarding the consequences of cigarette smoking and their relationships to smoking status in a biracial sample. Health Psychol. 1988;7:387-401. 12. Field AE, Cheung L, Wolf AM, et al. Exposure to the mass media and weight concerns among girls. Pediatrics. 1999;103:E36. 13. Cavallo DA, Duhig AM, McKee S, et al. Gender and weight concerns in adolescent smokers. Addict Behav. 2006;31:2140-2146. 14. Pomerleau CS, Zucker AN, Stewart AJ. Characterizing concerns about post-cessation weight gain: results from a national survey of women smokers. Nicotine Tob Res. 2001;3:51-60. 15. Camp DE, Klesges, RC, Relyea G. The relationship between body weight concerns and adolescent smoking. Health Psychol. 1993;12:24-32. 16. Heatherton TF, Kozlowski LT, Frecker RC, et al. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991;86:1119-1127. 17. Kozlowski LT, Porter CQ, Orleans CT, et al. Predicting smoking cessation with self-reported measures of nicotine dependence: FTQ, FTND, and HIS. Drug Alcohol Depend. 1994;34:211-216. 18. Moolchan ET, Ruckel SJ. Tobacco cessation for adolescents: Developing a group therapy approach. J Child and Adolesc Subst Abuse. 2002;1265-1292. 19. Reich W. Diagnostic interview for children and adolescents (DICA). J Am Acad Child Adolesc Psychiatry. 2000;39:59-66. 20. Moya T, Fleitlich-Bilyk B, Goodman R, et al. The Eating Disorders Section of the Development and Well Being Assessment: development and validation. Rev Bras Psiquiatr. 2005;27:25-31. n
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Weight Gain, Related Concerns, and Treatment Outcomes Among Adolescent Smokers Enrolled in Cessation Treatment Elissa Thorner-Bantug, MHS; Maria Jaszyna-Gasior, MD, PhD; Jennifer R. Schroeder, PhD; Charles C. Collins, BS; Eric T. Moolchan, MD
Funding/Support: This study was supported in full by funds from the National Institutes of Health, National Institute on Drug Abuse, Intramural Research Program. We examined associations of weight concerns and weight gain with adolescent tobacco cessation treatment and whether these effects differed by gender or ethnoracial group. Participants were 115 urban adolescents recruited for a randomized clinical trial of nicotine replacement therapy. Baseline weight gain concerns were assessed using the Eating Disorders module from the Diagnostic Interview for the Child and Adolescent (DICA-IV). The average weight gain during the trial was 0.59 ± 2.85 kg among the 43.5% of participants who completed the treatment study. As indicated by the DICA, baseline weight gain concerns were not associated with weight gain during treatment, study completion, or abstinence from smoking at 3-month posttreatment follow-up; these results did not vary by gender or ethnoracial group. Adolescents who quit smoking gained no more weight during the trial than those who smoked. Keywords: children/adolescents n tobacco n body weight n prevention n treatment J Natl Med Assoc. 2009;101:1009-1014 Author Affiliations: Department of Health and Human Resources, National Institutes of Health, National Institute on Drug Abuse–Intramural Research Program, Biomedical Research Center, Baltimore, Maryland. Dr Moolchan is currently at Alkermes Inc, Cambridge, Massachusetts. Corresponding Author: Eric Moolchan, MD, Medical Director, Clinical Science, Alkermes Inc, 88 Sidney St, Cambridge, MA 02139 ([email protected]).
Introduction
L
ately, the pressure to lose weight and become physically fit has become more of a cultural norm in our society. As a result, a relationship between fear of gaining weight and tobacco cessation has been well documented in adult studies and has sparked concern among the general public. Tobacco use is the number 1 preventable cause of chronic disease and death under-
JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
scoring the urgency of addressing smoking cessation among adolescents before they become regular smoking adults. Smoking initiation, delay in cessation treatment, and relapse to smoking after quitting have all been linked to a fear of weight gain among both men and women.1-3 Because a subset of smokers may defer seeking cessation treatment for fear of weight gain,4 fear of weight gain may delay cessation and thus expose the smoker to accruing risk of morbidity and premature death. Studies examining postcessation weight gain in adult samples have consistently demonstrated weight gain in the first few months post cessation. Sorensen and Pechacek reported that women were less likely than men to engage in quitting and attributed this difference to fear of weight gain.5 Moreover, a 2001 US surgeon general’s report concluded weight gain was almost 3 times more likely to cause relapse in women compared to men (20% vs 7%).6 From 15 prospective epidemiological studies of postcessation weight gain, an average gain of 1.82 to 3.64 kg was found among adults, regardless of gender, smoking history, or cessation modality.7 In addition, a 2007 study conducted by the University of Michigan found that women who smoke tend to be further from their self-identified ideal body image and more prone to dieting and bingeing behaviors, compared to nonsmokers.8 Concerns about weight are also prevalent among adolescents and associated with smoking and cessation behaviors. In a sample of adolescent high school students, Rosen and Gross found that two-thirds of girls and one-half of all boys were tying to modify their weight.9 Among adolescent girls, tobacco smoking has been well documented as a weight loss modality.2,10 Apprehension about weight gain has been prospectively associated with outcomes in cessation studies among adolescents, suggesting adolescents who smoke may also fear weight gain upon cessation and, therefore, delay or decline tobacco cessation treatment.11 In the United States, fear of weight gain and actual postcessation weight gain has been demonstrated to deter youth from maintaining abstinence from smoking, particularly for adolescent girls as compared to boys.12,13 VOL. 101, NO. 10, OCTOBER 2009 1009
Weight gain, related concerns and treatment
In addition to the impact of gender, weight concerns also seem to be influenced by race and ethnicity. Important differences in the degree of concerns pertaining to weight gain (hereafters “weight concerns”) seem to follow cultural and ethnic norms in the United States. Compared with the general US population, being overweight has been shown to be more socially acceptable within African American culture.14 Furthermore, Caucasian girls more frequently report smoking to lose weight compared to Caucasian boys, African American boys, or African American girls, and smoking as a weight loss modality was highly related to race among girls.15 Thus, a substantial body of research suggests fear of weight gain may deter or at least delay cessation, and smokers who fear weight gain may be less successful at cessation. We examined the frequency of weight concerns in adolescents enrolled in a 3-month clinical trial for smoking cessation to determine whether pretreatment weight concerns were associated with weight change during the study, completion of treatment, or successful abstinence from smoking at the 3-month follow-up visit (6 months after the quit date). This population of adolescent regular daily smokers is important to study because they are at high health risk and stand to gain the most benefit from quitting compared to less heavy smokers. Analyses were done for the whole sample then separately for boys and girls to determine if any associations between weight concerns and cessation outcomes varied by gender. For girls only, analyses were then done separately for African Americans and Caucasians to determine whether associations between weight concerns and cessation outcomes varied by ethnicity among these adolescents.
Methods
institute review board (IRB). All participants who called were interviewed by trained research staff. Those who prequalified for the trial based on the telephone interview were invited to the clinic, where a detailed medical history and physical examination were obtained, along with other clinical and psychosocial assessments by a multidisciplinary team of physicians, physician assistants, social workers, psychologists, nurses, and bachelor-level research assistants. The risks and benefits of the treatment study were explained, and adolescent participants’ assent and parental/guardian permission (consent) were obtained. In order to qualify for the treatment study, candidates were required to smoke a minimum of 10 cigarettes per day and score at least 5 out of 10 on the Fagerström Test for Nicotine Dependence (FTND).16 The FTND is a reliable and validated instrument for determining level of tobacco dependence and predicts outcome with cessation treatment among adult smokers.17 Exclusion criteria for this study included recent use of NRT or buproprion, untreated acute psychiatric disorders, drug or alcohol dependence (other than nicotine), and pregnancy. Qualified participants were randomized to receive NRT patch with placebo gum, NRT gum with placebo patch, or placebo gum and placebo patch. All study participants attended group cognitive behavioral therapy led by a trained social worker.18 While advising participants to adopt a healthy lifestyle, including maintaining an appropriate caloric intake and healthy activities, the cognitive behavioral therapy did not specifically instruct participants in any particular food intake monitoring, diet, or exercise program. Treatment was provided for 12 weeks; a follow-up visit was scheduled 3 months after the end of treatment.
Subjects
Measures
Participants recruited for this study were 13- to 17 year-old volunteers who resided in the Baltimore, Maryland, metropolitan area. Youths responded via telephone to advertisements for a smoking cessation treatment trial that employed both pharmacological (random assignment to a nicotine replacement therapy [NRT] group patch, gum, or placebo) and cognitive behavioral group therapy to quit smoking. This study was advertised through a variety of media, including radio, television, word-of-mouth, clinical referrals, and print. Despite Baltimore city’s predominant African American population, outreach efforts included ethnically targeted radio station advertisements and other community channels (eg, schools, churches). All cessation trial participants who had complete data sets for the variables of interest were included in this analysis.
Ethnicities were determined by self-report. All participants underwent a detailed physical examination during which baseline height and weight were obtained. Weight was measured at each study visit, and height was assessed at the beginning and end of treatment. Weight change during the study was calculated as weight during the final study visit minus initial weight. Concerns regarding weight and body image were assessed prior to treatment using the eating disorders module from the Diagnostic Interview for Children and Adolescents (DICA-IV), a semistructured interview instrument based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition).19 The DICAIV eating disorders module is a reliable and validated instrument for clinical and epidemiological use in eating disorders in multiethnic adolescent samples.20 A participant was considered having weight concerns if he or she endorsed any of the 7 questions from the DICA regarding weight concerns (Box). Treatment outcome measures for this analysis were weight change during the
Procedures The treatment protocol was approved by the National Institute on Drug Abuse Intramural Research Program 1010 JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
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study, both absolute (final weight – initial weight) and relative (percent change: 100 × (final weight – initial weight) / initial weight); trial retention, both study completion and total number of days in the study; and abstinence from smoking at 3 months post treatment (ie, selfreport of no smoking during the 3 months after study completion and confirmed expired carbon monoxide concentration ≤ 6 parts per million at the 3-month follow-up visit). Participants who dropped out of the study prior to the 3-month follow-up visit were assumed to be smoking.
Statistical Analysis This was a secondary analysis and no separate power analysis dictated the sample size. The sample size was determined by the power calculation for the clinical trial, and all participants with the variables of interest were entered into the analysis. c2 Tests were used to determine associations of weight concerns with gender and ethnicity (African Americans vs Caucasians) for girls only due to the small number of boys in this sample (n = 11) who indicated weight concerns. Two-sample t tests were performed to determine whether having weight concerns was associated with weight change during the study (both absolute and relative). Survival analysis assessed the association between weight concerns and study retention; both log-rank and Wilcoxon tests were performed due to their complementary nature (the log-rank test is more sensitive to later differences in survival curves, while the Wilcoxon is more sensitive to earlier differences). c2 Tests were used to determine whether having weight concerns was associated with study completion (operationalized as missing fewer than 3 clinic weekly visits and attending the end-of-treatment and 3month follow-up) and with abstinence from smoking at the 3s-month follow-up visit. Fisher’s exact tests were substituted for c2 tests if low cell sizes violated assumptions necessary for the c2 test to be valid. To determine whether relationships differed by gender and ethnicity, all analyses that assessed the association between weight concerns and study outcomes (retention, completion, weight gain, cessation) were done separately by gender, and ethnicity for girls only. The type I error rate was established at p = .05. All analyses were done using SAS version 8.2 (SAS Institute, Cary, North Carolina).
Results Participant Characteristics Figure 1 provides a diagram detailing how we arrived at the analyzable cohort. Of the 120 adolescents who participated in the smoking cessation trial, 5 had missing data on weight concerns. Thus, 115 participants were included in this analysis. Participants were 15.2 ± 1.3 years of age on average. The sample was 70.4% female, and 71.3% self-reported Caucasian ethnicity. Other groups included 23.5% (19/81) African American, 1.2% (1 of 81) Native American, and 1.2% (1 of 81) of mixed ethnicity. At enrollment, our sample had been smoking for 3.9 ± 2.0 years and averaged 18.6 ± 8.5 cigarettes per day with an FTND score of 7.0 ± 1.3 (out of a maximum score of 10), indicating high dependence. The mean body mass index was slightly above the national average and was 25.3 ± 6.3 kg/m2 for the study population. From this sample, 66.1% (76 of 115) were randomized to receive active NRT (patch or gum). Assignment to treatment arm was not significantly associated with baseline weight concerns, weight change during the study, retention time, or abstinence from smoking, so it was not a potential confounder in the relationships between baseline weight concerns and treatment outcomes. More than half (61 of 115, 53.0%) of the sample endorsed at least 1 weight concern at baseline. Endorsement of at least 1 weight concern was significantly more common among girls when compared to boys (61.7% vs 32.4%, p = .004). In addition, there were significantly more girls than boys who agreed with the statement, “Have you ever thought you were too fat when people said you were too thin?” (34.6% vs 8.8%, p = .0045).
Association of Weight Concerns With Study Outcomes in the Full Sample Participants who indicated baseline weight concerns gained slightly more weight during the study than participants who did not (0.84 ± 0.35 kg vs 0.30 ± 0.42 kg), but this difference was not statistically significant (p =.33). Baseline weight concerns were also not significantly associated with study completion rate (41.0% vs 46.3%, p = .57); median retention time (42 days vs 56 days, p = .27 log rank, p = .14 Wilcoxon); or abstinence from smoking at 3 months post treatment (11.5% vs 11.1%, p > .99) (Table 1).
Box. Questions Assessing Weight Concerns From the Diagnostic Interview for Children and Adolescents Do you spend a lot of time trying to lose weight by dieting? Have you ever thought you were too fat even though people said you were too thin? Have you ever gone on any eating binges? Did you try to keep from gaining weight by taking laxatives or diuretics? Did you make yourself throw up to keep from gaining weight? Did you exercise a lot to keep your weight down? Did you worry a lot about gaining weight?
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Association of Weight Concerns With Study Outcomes Assessed Separately by Gender
casians than African American girls (68.3% vs 36.8%; c2 = 6.0, p = .014). Caucasian girls endorsed 3 individual items more frequently than African Americans: “Do you spend a lot of time trying to lose weight by dieting?” (50.0% vs 21.1%, c2 = 4.93, p = .026), “Do you exercise a lot to keep your weight down?” (36.7% vs 5.3%, c2 = 6.90, p = .0086), and “Did you worry a lot about gaining weight?” (21.7% vs 0%, Fisher’s exact p = .031). As was seen in the subgroup analyses by gender, endorsement of baseline weight concerns was not associated with study outcomes, and this lack of association was evident for both Caucasian and African American girls. Ethnicity did not modify the effect of baseline weight concerns on weight gain during the study, study completion rate, retention time, or abstinence from smoking at 3 months post treatment (Table 3).
As was true for the full sample, endorsement of baseline weight concerns was not associated with study outcomes for either girls or boys. Table 2 provides the results of this stratified analysis, which includes group differences (weight concerns vs no weight concerns) and associated p values presented separately by gender.
Association of Weight Concerns With Study Outcomes Assessed Separately by Ethnicity for Girls
This analysis was limited to 79 girls who were either African American (n = 19) or Caucasian (n = 60); 2 girls of other ethnicity were excluded from these comparisons. Endorsement of at least 1 of the weight concern questions was significantly more common among CauFigure 1. Participant Enrollment
Eligible per Phone Screen 329
Failed to Show
Consented to Study
170
159 Randomized
Ineligible 39
120
22 - Psychiatric problems 9 - Medical problems Study Sample 115
Incomplete Questionnaires 5
4 - Substance abuse/dependence 2 - Attempting to conceive 2 - Failed to return
Table 1. Association of Weight Concerns With Study Outcomes in the Full Sample (N = 115)a-d Outcome Measures Weight change during study Absoluteb Relativec Study completion rate (%) Median study retention (days) Abstinenced
Weight Concerns (N = 61)
No Weight Concerns (N = 54)
0.84 ± 0.35 kg 1.09 ± 0.50% 41.0% 42 days
0.30 ± 0.42 kg 0.33 ± 0.57% 46.3% 56 days
11.5%
11.1%
P Value t = –0.99, p = .33 t = –1.00, p = .32 c2 = 0.33, p = .57 Log rank p = .27 Wilcoxon p = .14 Fisher’s exact p > .99
a
Outcome measures were available for all participants with the exception of weight change.
b
F inal minus initial weight. Data available were for 59 participants with weight concerns and for 52 participants without weight concerns (111 total).
c
ercent change. Data available were for 59 participants with weight concerns and for 52 participants without weight concerns (111 P total).
d
Defined as no tobacco use at the 3-month follow-up visit.
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Discussion
This study examined several relationships between pretreatment weight concerns, weight gain during treatment, and treatment outcomes among a multiethnic group of teenage smokers enrolled in a smoking cessation trial. Our results do not support that concerns regarding weight are associated with weight gain during cessation treatment or poorer treatment outcome. Moreover, in contrast to adult cessation studies,5 weight gain during smoking cessation treatment was not associated with posttreatment abstinence. The limitations of these findings must be considered when interpreting our results. First, this sample of heavysmoking treatment-seeking adolescents is not likely to be representative of all adolescent smokers attempting to quit. The inclusion was set at a minimum of 10 ciga-
rettes per day to ensure an acceptable risk-benefit ratio for the administration of NRT to this young population. Also, this study was started in 1999, when the few programs that offered cessation for adolescents were research based. Therefore, we likely oversampled very heavy smokers (the most motivated and urgently in need of intervention). The lack of statistical power also precludes definitive conclusions regarding the impact of gender and race/ethnicity on the relationship between weight concerns and smoking cessation outcome. Also, the DICA questions that elicited differences between Caucasians and African Americans might have partially reflected differences in the social perceptions of being overweight, and further studies using culturally sensitive instruments are thus warranted. Finally, the large variability in the mean weight change (among ethnoracial
Table 2. Weight Concerns and Abstinence by Gender (N = 81 Girls, N = 34 Boys)a Weight Concerns No Weight Concerns Gender (N = 50 Girls, N = 11 Boys) (N = 31 Girls, N = 23 Boys) P Value Girls 10% 9.5% p > .99 Boys 18.8% 11.1% p = .65 Study completion rates, % Girls 40% 38.1% c2 = 0.024, p = .88 Various Outcomes Abstinence rates, %
Median retention time, d
Weight change, kgb
Boys Girls
62.5% 42
44.4% 42
Boys
168
56
Girls Boys
0.59 ± 0.27 1.86 ± 0.82
–0.05 ± 0.36 0.09 ± 1.18
c2 = 1.11, p = .29 Log rank p = .89 Wilcoxon p = .67 Log rank p = .32 Wilcoxon p = .38 t = 1.21 p = .23 t = –1.26 p = .22
a
Outcome measures were available for all participants with the exception of weight change.
b
F inal minus initial weight. Data available were for 78 girls (48 with and 30 without weight concerns) and 33 boys (11 with and 22 without weight concerns).
Table 3. Weight Concerns and Study Outcome Measures at 6 Months (3 Months’ Posttreatment Followup) by Ethnicity Among 79 Girls (N = 19 African American, N = 60 Caucasians)a,b
Outcome Abstinence, % Study completion, %
Ethnicity African American Caucasian African American Caucasian
Median retention time, d
African American Caucasian
Weight change, kgb
African American Caucasian
Weight Concerns (N = 7 African Americans, N = 41 Caucasians) 20%
No Weight Concerns (N = 12 African Americans, N = 19 Caucasians) 11.1%
P Value p > .99
8.3% 40%
8.3% 33.3%
p > .99 Fisher’s exact p > .99
39.6%
41.7%
Fisher’s exact p > .99
42
35
42
49
–0.64 ± 0.91
–0.14 ± 0.50
Log rank p = .87 Wilcoxon p = .97 Log rank p = .71 Wilcoxon p = .58 t = 0.45 p = .66
0.86 ± 0.32
.05 ± 0.55
t = –1.26 p = .21
a
Outcome measures were available for all participants with the exception of weight change.
b
F inal minus initial weight. Data available were for all African American girls (7 with and 12 without weight concerns) and 57 Caucasian girls (39 with and 18 without weight concerns).
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and gender subgroups) may have obscured the relationships between weight change and relevant variables. Future studies should strive to obtain larger samples of adolescents to provide more conclusive evidence of the relationships between weight gain, weight concerns, and adolescent smoking cessation. Despite its limitations, this study offers preliminary evidence that weight concerns, though common, might not be substantially associated with cessation outcome for adolescents engaged in treatment. The average weight gain during this study was small, and was not associated with tobacco abstinence. While larger studies are needed to more thoroughly study these relationships, our findings might potentially allay concerns that weight gain during a cessation attempt is inevitable, and encourage adolescents who desire to quit smoking not to defer cessation treatment due to concerns about weight gain.
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