Reducing Both Food Insecurity and Excess Body Weight in Costa Rican Women: A Cluster Randomized Trial

Reducing Both Food Insecurity and Excess Body Weight in Costa Rican Women: A Cluster Randomized Trial

ARTICLE IN PRESS RESEARCH ARTICLE Reducing Both Food Insecurity and Excess Body Weight in Costa Rican Women: A Cluster Randomized Trial Tatiana Mart...

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RESEARCH ARTICLE

Reducing Both Food Insecurity and Excess Body Weight in Costa Rican Women: A Cluster Randomized Trial Tatiana Martínez-Jaikel, PhD,1 Edward A. Frongillo, PhD,2 Christine E. Blake, PhD,2 Maryah S. Fram, PhD,3 Viviana Esquivel-Solís, MSc1

Introduction: The coexistence of food insecurity and excess body weight has been well documented in women. Both food insecurity and excess body weight have multiple consequences for physical and mental health. Concerns have been raised about interventions aimed to reduce food insecurity because these interventions might contribute to excess body weight, particularly in adult women. The purpose of this study was to develop, implement, and evaluate an intervention to simultaneously reduce food insecurity and body weight through alleviating discouragement—which women described as feeling sad, depressed, hopeless, and lacking drive to do important activities, such as finding a job or studying more—by increasing women’s empowerment. Study design: This 2-armed cluster RCT was conducted from February to December 2017. Data were analyzed from January to July 2018.

Setting/participants: Participants were food-insecure women with excess body weight in the Central Canton of the province of Alajuela, Costa Rica.

Intervention: The intensive intervention arm consisted of activities at the individual (12 sessions lasting 2 hours each, 3 follow-up monthly sessions, and 1 closing session), household (1 workshop with the participants’ household and community members and homework with family participation), and community (2 brochures and 1 workshop) levels. The nonintensive control arm consisted of 3 sessions about healthy lifestyles lasting 1 hour each.

Main outcome measures: Outcome measures included BMI, waist circumference, and food insecurity.

Results: A total of 171 participants were enrolled (83 in intensive and 88 in nonintensive control arms). At 6 months, the intensive arm had greater decreases from baseline in BMI ( 0.648, p=0.019), waist circumference ( 2.21, p=0.002), and food insecurity ( 1.35, p=0.009) compared with the nonintensive control arm.

Conclusions: The intensive intervention was effective in simultaneously reducing food insecurity and excess body weight. Educational components should be added to interventions aimed to reduce food insecurity.

Trial registration: This study is registered at www.clinicaltrials.gov NCT03492619. Am J Prev Med 2020;000(000):1−12. © 2020 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

From the 1School of Nutrition, University of Costa Rica, San Jose, Costa Rica; 2Department of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, South Carolina; and 3 College of Social Work, University of South Carolina, Columbia, South Carolina

Address correspondence to: Tatiana Martínez-Jaikel, PhD, School of Nutrition, University of Costa Rica, Ciudad de la Investigacion, Finca 2, Sabanilla 2060, San Jose, Costa Rica. E-mail: [email protected]. 0749-3797/$36.00 https://doi.org/10.1016/j.amepre.2019.11.021

© 2020 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

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INTRODUCTION ousehold food insecurity occurs when “the availability of nutritionally adequate and safe foods or the ability to acquire acceptable foods in socially acceptable ways is limited or uncertain.”1 In 2014, in Costa Rica, 19.9% and 4.4% of people aged 15 years and older were, respectively, moderately to severely and severely food insecure.2 Household food insecurity has many household, social, and physical and mental health consequences including depression and excess body weight.3−6 Excess body weight affects all countries globally.7 Costa Rica has experienced a nutritional transition characterized by reduction of undernutrition and increasing obesity.8 In 2008−2009 in Costa Rica, 59.7% of women aged 20−44 years had excess body weight, reaching 77.3% in those aged 45−64 years.9 Excess body weight has multiple health consequences related to later development of cardiovascular disease, cancer, depression, lack of self-esteem, and premature mortality.7,10,11 Coexistence of food insecurity and excess body weight has been well recognized4,5,12,13 and occurs particularly in women.14−17 For example, adult women in moderately food-insecure households in Brazil had a 49% higher risk of being obese when compared with food-secure counterparts.15 Because food insecurity is linked with resource constraints and undernutrition, many programs provide food directly or through vouchers or cash benefits intended to improve households’ access to adequate nutrition but often are not accompanied by nutrition or health education or address mental health. These programs might contribute to excess body weight, particularly in adult women.17−19 A cluster randomized trial in Mexico providing poor rural households with cash or food transfers showed that the program led to weight gain in women, particularly those already obese.19 Interventions are needed that reduce food insecurity while simultaneously reducing excess body weight. The authors’ previous qualitative research showed that discouragement—which women described as feeling sad, depressed, hopeless, and lacking drive to do important activities, such as finding a job or studying more—is the primary link in the coexistence of food insecurity and excess body weight among Costa Rican women, and that family and existing gender norms contribute to and compound this coexistence.20 Family members may insult women because of their excess weight and do not support them when trying to lose weight. Some women are economically dependent on male partners because traditionally he should be the home provider and women do domestic work and care for children; women’s capacity to

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make food and other choices, dedicate time to self-care, and reach their own dreams and goals is limited. These conditions lead women to have reduced psychological empowerment, defined as “people’s belief that they have the resources, energy, and competence to accomplish important goals.”21 If women believe that they cannot make changes, they will not be motivated to act to improve their lives and will feel discouraged (Appendix Figure 1, available online). This study aimed to develop, implement, and evaluate an intensive intervention seeking to alleviate discouragement by increasing women’s empowerment targeted at the individual, family, and community levels in Alajuela, Costa Rica. The hypothesis was that the intensive intervention, compared with a nonintensive control, would simultaneously reduce food insecurity and excess body weight and improve social support for healthy eating, psychological and economic empowerment, and food and physical activity behaviors.

METHODS The study occurred between February and December 2017. Data analysis occurred from January to July 2018. The study was implemented by the School of Nutrition of the University of Costa Rica, the women’s and employability office of the Municipality of Alajuela, and the local association Agenda de Mujeres, supported by the University of South Carolina. These first 3 institutions have worked together for 12 years conducting healthy lifestyles groups and research in the study location. The study protocol was approved by the IRB at the University of South Carolina and the Ethical-Scientific Committee of the University of Costa Rica. It is registered at clinicaltrials.gov (NCT03492619).

Study Sample Cluster randomization22 was done with the Basic Provision Units of Integrated Healthcare (acronym EBAIS in Spanish), the first level of care providing primary and preventative health care to all in a catchment area (i.e., a geographical area of around 4,000 people that usually lives close to each other). In the Central Canton of Alajuela, there are 53 EBAISs. The 30 EBAISs for the catchment areas with the lowest socioeconomic level and with geographic proximity to the center of Alajuela were selected. For comparability of the 2 arms, matched EBAISs were paired according to participants’ BMI and food insecurity score at recruitment. An author without knowledge of the communities randomly assigned each EBAIS in a pair to either the intensive intervention or nonintensive control with computer-generated random numbers, resulting in 15 EBAISs per arm. The first author implemented the assignments. Cluster randomization helped avoid contamination between the arms. Intervention duration was 6 months. Assessments on individuals were conducted at baseline, 3 months, and 6 months, except the economic empowerment and social support questionnaires, which were only applied at baseline and 6 months. After each assessment, women received a gift incentive (T-shirt, water bottle, and sport bag). www.ajpmonline.org

ARTICLE IN PRESS Martínez-Jaikel et al / Am J Prev Med 2020;000(000):1−12 The sample size was calculated using clustersampsi in Stata, version 14.1. A sample size of 75 women per arm, assuming a power of 0.9, an intraclass correlation of 0.05, an a of 0.05, and an SD of 2.5, which was taken from previous studies in Costa Rica,23 could detect mean differences in body weight of 1.5 kg. With an SD of 5 for food insecurity,24 the sample could detect differences of 3 scale units. Up to 7 per EBAIS were recruited to account for possible attrition. The study began with 83 women in the intensive intervention arm and 88 in the nonintensive control arm, and a mean of 5.7 women per EBAIS. Women were recruited through communal leaders, posters that were placed in the EBAIS, and social media before community assignment to study arms. At recruitment of potential participants, communal leaders were blinded to the study arm to which the community had been randomized; data collectors and participants were not blinded. Eligible women met the following criteria: excess body weight (BMI ≥25), age 18−60 years, food insecure,24 in catchment area of a selected EBAIS, able to read and write, at least 1 other adult household or family member willing to participate fully in the intervention, no diagnosis of diabetes mellitus, and not pregnant. Meetings of interested women were organized to explain the study, measure weight and height, conduct screening interviews, and administer the food insecurity questionnaire.24 Women who were interested but did not meet the criteria were invited to participate in healthy lifestyles sessions offered by the Municipality of Alajuela. For women meeting the criteria, after recruitment and randomization, meetings were organized to invite their participation. Women who decided to participate were administered written informed consent and were invited to the first measurement session. Women in the nonintensive control arm received 3 sessions lasting 1 hour about healthy lifestyles. Sessions were held the same day that women completed questionnaires and anthropometric assessments. The intensive intervention arm consisted of activities at individual, household, and community levels. At the individual level, the intervention comprised 12 sessions lasting 2 hours, 3 followup monthly sessions, 1 workshop with participants’ household and community members, and 1 closing session. It was implemented in 5 different groups of women having about 15 participants each. Session topics were based on previous research23,25,26 and experience of previous groups; sessions related to employability were added. Sessions included 3 components: (1) eating healthy at low cost, including how to cook healthy and inexpensively; (2) psychological empowerment, for example, assertiveness and self-esteem; and (3) development of a life project—defined as a plan about goals that women seek in all the spheres of their lives such as career, family, or social life—focusing on improving employability and recognition of women’s dreams and goals in life. Examples of women’s foci for projects were studying more, finding a job, and starting a micro-business (Table 1). Each session was structured based on stages of interactive group nutritional education27 and consisted of opening and framing (40 minutes), including physical activity and discussion about whether it was easy or difficult to reach last week’s goals and complete the homework; revision of participant’s experiences about the topic to help them examine their behaviors realistically (10 minutes); development of main ideas about the topic (45 minutes); feedback to ensure participants understood the main & 2020

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session’s messages (10 minutes); and setting goals and closing the session (15 minutes). The session “Cooking Healthy and Cheap” took place at the University of Costa Rica so women could experience a university course. After sessions, women received a healthy snack with the recipe. Women invited household members to attend a workshop about household co-responsibility, self-care, and nutrition aimed at changing gender norms and gendered behaviors. A theater performance and a theater forum were used to increase message acceptance. To promote social support, 6 assignments required participation of household members. Two brochures about co-responsibility and self-care were developed that were distributed in the communities by participating women. Community members participated in workshops held after the first 3 months of the individual-level activities. The first author with the professionals of the participating institutions developed the educational matrices and materials of each session and conducted all sessions and workshops in both arms. During sessions, notes were taken to evaluate to what extent sessions were conducted as programmed. All activities were held as planned. Eight sessions were conducted to explain and invite people to participate in the study, 15 educational sessions with the 5 intensive intervention groups (75 sessions), and 3 short educational sessions with 3 nonintensive control groups. Different schedules were offered to promote women’s participation. Women in the intensive intervention arm attended 53.3% of sessions, and 99% of them indicated the sessions were very helpful for them. Two similar workshops were conducted on 2 different days for participants’ convenience, attended by 40 participant women, 34 family members, and 9 community members.

Measures Primary outcomes were changes from baseline to 6 months in food insecurity, BMI, and waist circumference. Secondary outcomes were changes in psychological and economic empowerment, social support, and physical activity and food behaviors. BMI was calculated as weight (kg)/height (m2). Weight was measured (to 0.1 kg) using a Tanita BC-549 scale. Height was obtained at baseline using a portable stadiometer Seca 213 (to 0.1 cm). Waist circumference was measured (to 0.1 cm) at the midpoint between the iliac crest and the lowest rib. The 3 measures were taken twice. When there was a difference of 0.1 kg (weight) or 0.5 cm (height or waist circumference) between 2 measurements, a third was taken. The mean of the 2 closest measurements was used. Enumerators were trained, repeating each measurement 20 times in 2 women with the same characteristics as the study population. The measurements of each person were compared with those taken by an expert anthropometrist. The first author took all waist circumference measurements. The food insecurity scale of household experiences, previous validated in Costa Rica, had 14 items.24 The response categories were never, sometimes, and many times. The scale’s internal consistency reliability (Cronbach’s a) at baseline was 0.917. Empowerment was measured by the agency subscale of the Scale of Personal Agency and Empowerment,28 which was validated in Mexico. It includes the concepts of self-efficacy, selfdetermination, autonomy, and control and has 35 Likert items with 4 responses (1=none, 2=rarely, 3=almost always, 4=always). This subscale had a Cronbach’s a of 0.892 at baseline.

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Table 1. Overview of the Objectives by Session for the Interventions in the Intensive Intervention Arm and Nonintensive Control Arm Session number Intensive intervention arm 0

Name

Presentation

Content

 Presentation of the study and answering questions of the participants  Importance of involving a household member in the intervention  Signing the consent form  Presentation of the participants  Intervention’s goals and calendar of sessions  Making a group contract, including participation in the community intervention  Setting goals

Homework with family participation

1 ‒ Baseline measurement session

Baseline measurements: group organization and setting goals

2

Taking care of my needs, and those of others

3

Impact of food and physical activity in health

4

Eating healthy and saving money Saving money

 Knowing your portion sizes  Strategies for eating healthy at low cost  Discussion about food insecurity experiences  Strategies to save money  Making a budget  Sharing experiences about how to save money

Homework 3: discuss with the family member strategies for saving money in the household, including making a budget

Workshop: cooking healthy and cheap Understanding anxiety

 Healthy low-cost recipes

Homework 4: practicing at home

Saying what you really want to say and making decisions Understanding beauty patterns, body image, and self-esteem

 Communication styles: passive, aggressive, assertive  Assertiveness techniques  Decision-making process  What is self-esteem?  How to love ourselves  How is body image built?  Different beauty patterns through history  Different types of bodies

Homework 5: applying one of the learned techniques with a household member

10

Life project: dreams and goals

Homework 6: share my life project with the selected household member

11

Life project: available resources

      

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The role of sisterhood among women

5

6 7

8

9

 Living conditions of women in Costa Rican society  Taking care of my needs: nutrition, physical activity, and mental health  What can good nutrition and physical activity do for your life?  Food groups  Energy balance: how do we lose weight?

    

Homework 1: explaining the project to the selected household member

Homework 2: discuss with the family member 2 things that you learned during the session

Relaxation exercise What is anxiety? What causes anxiety? What happens when I feel anxiety? How to cope with anxiety

What is a life project? How to make a life project? What are my dreams and goals in life? Making my life project How to find a job How to write a resume Services offered by the employability office

 What is sisterhood  How can women support each other? (continued on next page)

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Table 1. Overview of the Objectives by Session for the Interventions in the Intensive Intervention Arm and Nonintensive ?Control Arm (continued) Session number 3-month measurement session 13 14 15 6-month measurement session Closing session

Nonintensive control arm 0

Name

Content

3-month measurements

 Process evaluation

Follow-up monthly sessions Follow-up monthly sessions Follow-up monthly sessions Final measurements

 Legal advice  Social defense services  Understanding food nutrition labels

Closing activity

 Some study results were presented to the participants  Cultural events carried out by participating women  Participants received a participation certificate

Presentation

 Presentation of the study and answering questions of the participants  Signing the consent form  Presentation of the participants  Intervention’s goals and calendar of sessions  Changing my lifestyle  Setting goals

 Starting your own business  Qualitative interviews

1 ‒ Month 0

Baseline measurements

2 ‒ Month 3

3-month measurements 6-month measurements

   

Closing activity

 Some study results were presented to the participants  Cultural events carried out by participating women  Participants received a participation certificate

3 ‒ Month 6 Closing

Understanding my BMI values How to lose weight Tips to practice physical activity My experiences in the group

Social support was measured by the Social Support and Eating Habits Survey.29 This scale was validated in the U.S and other countries and was created to measure participants’ perceived support from family and friends for healthy eating in the previous 3 months. It has 10 items with ratings made on a 5-point Likert scale from none (1) to very often (5). Items 1−5 and 6−10 represent encouraging and discouraging support for healthy eating, respectively. The Cronbach’s a ranged from 0.786 to 0.906 for the 4 subscales at baseline. The subscales were scored separately for family and friends. Economic empowerment was measured with 3 separate items related to household decision making about food purchasing and contribution to household support30: Who in your family decides which foods to buy in the household?, Who is the person in charge of food shopping in your household?, and Who contributes to

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Homework with family participation

household support? Three measures of economic empowerment at the end of the intervention were also used: (1) number of women that visited the employability office of the Municipality, (2) number of women that engaged in any courses, and (3) number of women that obtained a job. Because no appropriate scale for discouragement was found, psychological and economic empowerment were used as proxies. Higher scores on these reflected women feeling less discouragement. Physical activity was assessed by asking: During the last month, did you engage in physical activity? If women answered affirmatively, they were asked about the type of activity, how many times a week, and how many minutes in each session of physical activity. The METs per week of physical activity were calculated using the Compendium of Physical Activities.31

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To assess food behaviors, an 8-item food frequency questionnaire focused on the most problematic eating behaviors found in previous studies.23,26,32 Women answered in the past 30 days how frequently they consumed each food (times per day, per week, or per month) The answers were recoded to represent average monthly intake. At baseline, participants’ age, marital status, occupation, highest grade of completed education, income, and participation in assistance programs were measured. At the end, they were asked if they used and recommended to family and community members the women’s and employability office. All questionnaires were self-administered but supervised by the researchers to ensure that the women completed the questions correctly. Before the study, all the questionnaires were pretested and revised for a better understanding using a pilot group of 28 women similar to the study population.

Statistical Analysis Intervention effects were analyzed as intent to treat with all available data using multilevel, repeated-measures models that specified EBAIS and individual as nested random effects assuming an exchangeable correlation structure and with arm, visit, and the interaction of arm and visit as fixed categorical effects. The interaction quantified the differences between arms in changes from baseline to 3 months and from baseline to 6 months. Normality was checked using histograms and skew statistics for all outcomes. The food consumption and physical activity variables were positive skew, so square-root transformations were used. As a robustness check, an alternative method of analysis of covariance for such trials, regressing for example the 6-month outcome on the baseline outcome was conducted,33,34 to assess the differences between arms, obtaining similar results for all outcomes. To determine possible differences between people who did or did not complete the 3- or 6-month assessment in the intensive intervention and nonintensive control arms, age, BMI, food insecurity score, and psychological empowerment were compared at baseline and no differences by completion or not were found; furthermore, a sensitivity analysis was done by replacing missing follow-up values for the 4 primary outcomes by the corresponding baseline value and then repeating the analyses. Statistical analyses were conducted using Stata, version 14.1.

RESULTS There were 329 women from 30 EBAIS screened, with 243 meeting study criteria and randomly allocated by cluster to the 2 arms (Figure 1). Overall, 171 participants agreed to participate. The intensive intervention arm had 15 EBAIS (mean size, 5.5 participants; n=83; range, 2−10) and the nonintensive control arm had 15 EBAIS (mean size, 5.9 participants; n=88; range, 3−9). At 3 months, 19.3% and 6.8% did not complete the 3month surveys in the intensive intervention and nonintensive arms, respectively. Around half the attrition in the intensive arm (11.0% of the participants) took place during the first 2 sessions. At 6 months, around 80% in both arms completed the surveys.

The 2 arms were similar at baseline for the primary and secondary outcomes (Table 2). Mean age was 40.1 (SD=10.4) years in the intensive intervention arm and 43.9 (SD=8.8) years in the nonintensive control arm. In both arms, most of the women were living with a partner, had children, completed elementary school, and were homemakers. The intensive intervention arm had greater decreases from baseline to 6 months in BMI, waist circumference, and food insecurity compared with the nonintensive control arm (Table 3). Women in the intensive intervention arm decreased their BMI 0.648 kg/m2 more than did women in the nonintensive control arm (p=0.019). Women in the intensive intervention arm lost 2.44 kg, 1.65 kg (p=0.014) more than women in the nonintensive control arm. Obesity was reduced by 12.6 more percentage points in the intensive intervention arm (p=0.007) compared with the nonintensive control arm. Women in the intensive intervention arm reduced waist circumference 2.21 cm (p=0.002) more than women in the nonintensive control arm. Women in the intensive intervention arm reduced food insecurity 1.35 units (p=0.009) more compared with women in the nonintensive control arm. The intra-cluster correlations for BMI, waist circumference, and food insecurity were 0.059 3, 0.0722, and 0.000559, respectively. In the sensitivity analysis for attrition at 6 months for these outcomes, pvalues were 0.004−0.037, with intervention effects attenuated 19%−26%. The intensive intervention arm also had greater increases in psychological (p=0.041) and economic empowerment, including a greater increase in the contribution to household support (p=0.033), and more women that found a job (p=0.018), compared with the nonintensive control arm. Women in the intensive intervention arm increased their contribution to household support and found a job by, respectively, 18 and 21 percentage points more than women in the nonintensive control arm. The intensive intervention arm used the employability office 12.5 percentage points (p=0.022) more than women in nonintensive control arm; women in the intensive arm also recommended this office more than did women in the nonintensive control arm. Women in the intensive arm used the women’s office 9.6 percentage points (p=0.095) more than women in the nonintensive control arm. They also recommended this office to family and community members 20.5 percentage points (p=0.006) more than did women in the nonintensive control arm. Women in the intervention arm had greater decreases from baseline in consumption of fried foods (p=0.058), sausages (p=0.076), and sugary drinks (p=0.065), and greater increases in the consumption of salads (p=0.063) and beans (p=0.001) compared with women in the www.ajpmonline.org

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Figure 1. CONSORT diagram for the study. EBAIS, Equipos Basicos de Atencion Integral en Salud (Basic Provision Units of Integrated Healthcare).

nonintensive control arm. No differences between the intensive and the nonintensive control arms in social support, exercise, and consumption of fruits, vegetables, and fast foods were found. Except for social support, all of these outcomes also had changes in the expected direction in the nonintensive control arm. From baseline to 3 months, women in the intensive arm had greater changes in the expected direction in BMI (p=0.011); waist circumference (p<0.001); and food consumption of vegetables (p=0.019), salads (p=0.003), fried foods (p=0.004), sugary drinks (p=0.030), beans (p=0.029), and fast foods (p=0.070) compared with & 2020

women in the nonintensive arm (Appendix Table 1, available online).

DISCUSSION This intensive intervention, designed to alleviate discouragement by empowering women and changing gender norms and gendered behaviors for food-insecure women with excess body weight, reduced food insecurity while simultaneously reducing weight. The intensive intervention also improved psychological and economic empowerment and food behaviors.

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Table 2. Characteristics of Study Participants Variables Demographic Age, years, M (SD) Marital status, % Living with partner Widowed/separated/divorced Never married Socioeconomic, % Have children, yes, % Income, fixed Participation in assistance programs, % Educational attainment, % Incomplete elementary school Completed elementary school High school diploma Technical education Completed university Occupation, % Homemaker Domestic help Business owner Salaried Unemployed Student Primary outcomes BMI, kg/m2, M (SD) Waist circumference, cm, M (SD) Food insecurity, range 14‒42, M (SD) Secondary outcomes Psychological empowerment, range 35‒140, M (SD) Social support, range 5‒25, M (SD) Encouraging support family Discouraging support family Encouraging support friends Discouraging support friends Economic empowerment Participation purchase decision, yes, % Participation going shopping, yes, % Contribution household support, yes, % Food consumption, times per month, M (SD) Vegetables Salads Fruits Fried foods Sugar drinks Beans Fast food Exercise METs per week, M (SD)

Intensive intervention (n=83)

Nonintensive control (n=88)

40.1 (10.4)

43.9 (8.8)

61.4 26.5 12.0

63.1 23.8 13.1

91.6 53 21.7

95.2 44 27.4

12 45.8 20.5 10.8 10.8

9.5 57.1 15.5 10.7 7.1

49.4 7.2 12.0 20.5 7.2 3.6

55.9 9.5 7.1 21.4 4.8 1.2

34.3 (6.2) 99.6 (12.4) 20.4 (5.2)

33.9 (5.9) 98.8 (11.8) 20.8 (5.6)

92.2 (13.7)

91.8 (15.0)

13.2 (5.2) 14.6 (5.0) 10.5 (4.7) 12.3 (5.3)

12.8 (6.0) 13.1 (4.7) 10.7 (4.9) 11.2 (4.7)

95.2 94.0 53.0

92.9 88.1 60.7

15.5 (19.4) 16.5 (16.8) 25.7 (23.6) 17.1 (20.0) 34.6 (31.8) 29.0 (23.2) 3.94 (6.8) 6.7 (11.5)

11.3 (12.3) 16.1 (14.2) 22.8 (19.8) 14.8 (16.0) 34.0 (30.7) 33.7 (21.3) 4.6 (10.1) 6.3 (11.1)

Note: M and SDs are presented for continuous variables; percentages are shown for categorical measures. M, mean.

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Table 3. Baseline and 6-Month Differences by Arm and Effects of the Intensive Intervention Baseline Outcomea

Non- intensive controln=84

Intensive interventionn=65

Non- intensive controln=69

Difference in changesb

SEs

p-valuec

34.4 (0.745) 86.1 (2.04) 99.7 (1.53) 20.4 (0.538)

34.0 (0.727) 82.5 (1.99) 99.0 (1.50) 20.8 (0.525)

33.4 (0.751) 83.7 (2.05) 95.5 (1.55) 17.5 (0.560)

33.6 (0.731) 81.7 (2.00) 97.0 (1.51) 19.2 (0.541)

‒0.648 ‒1.65 ‒2.21 ‒1.35

0.277 0.668 0.711 0.513

0.019 0.014 0.002 0.009

92.2 (1.58)

91.1 (1.56)

98.7 (1.69)

93.9 (1.61)

3.70

1.807

0.041

13.2 (0.631) 14.6 (0.507) 10.6 (0.570) 12.1 (0.581)

12.7 (0.623) 13.2 (0.498) 10.7 (0.558) 11.3 (0.553)

14.7 (0.684) 13.4 (0.549) 10.9 (0.632) 11.9 (0.637)

14.0 (0.665) 13.1 (0.536) 11.0 (0.597) 11.5 (0.600)

0.203 ‒1.07 0.057 7 ‒0.512

0.918 0.760 0.903 0.945

0.825 0.157 0.949 0.588

95.2 94.0 53 — — —

93.1 88.4 61.1 — — —

96.0 94.8 68.9 38.0 18.2 27.3

93.1 91.0 59.2 17.0 5.70 24.3

0.763 ‒1.71 17.8 21.0 12.5 3.00

4.28 4.32 8.34 8.85 5.42 7.50

0.858 0.693 0.033 0.018 0.022 0.690

3.18 (0.224) 3.52 (0.244) 4.48 (0.253) 3.51 (0.211) 5.03 (0.307) 4.83 (0.255) 2.81 (0.206) 1.69 (0.130)

2.90 (0.223) 3.67 (0.242) 4.33 (0.251) 3.33 (0.209) 5.11 (0.305) 5.40 (0.253) 2.37 (0.203) 1.69 (0.130)

4.42 (0.248) 4.77 (0.265) 5.84 (0.280) 2.38 (0.233) 2.77 (0.338) 5.62 (0.278) 1.96 (0.226) 1.18 (0.143)

3.73 (0.240) 3.67 (0.242) 5.25 (0.270) 2.91 (0.226) 3.81 (0.327) 4.92 (0.269) 2.12 (0.202) 1.42 (0.139)

0.416 0.689 0.438 ‒0.708 ‒0.964 1.277 ‒0.589 ‒0.241

0.391 0.371 0.437 0.373 0.522 0.388 0.332 0.224

0.288 0.063 0.317 0.058 0.065 0.001 0.076 0.282

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Intensive interventionn=83

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Primary outcomes BMI, kg/m2, M (SE) Weight, kg, M (SE) Waist circumference, cm, M (SE) Food insecurity, range 14‒42, M (SE) Secondary outcomes Psychological empowerment, range 35‒140, M (SE) Social support range 5‒25, M (SE) Encouraging support family Discouraging support family Encouraging support friends Discouraging support friends Economic empowerment Participation purchase decision, yes, % Participation going shopping, yes, % Contribution household support, yes, % Found a job, yes, % Used employability office, yes, % Took courses, yes, % Food consumption, times per month,d M (SE) Vegetables Salads Fruits Fried foods Sugar drinks Beans Sausages Fast food

6-month

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Note: Intraclass correlations for BMI, waist circumference, and food insecurity were 0.0593, 0.0722, and 0.000559, respectively. Boldface indicates statistical significance (p<0.05). a Values are means § SE from the mixed-effects models. b sicos de Atencion Integral en Salud). Multi-level, repeated measures analysis for difference in changes accounting for clustering by EBAIS (Equipos Ba c Two tail p-values. d Results in differences and p-values after square-root transformation. M, mean.

0.007 4.64 70.4 71.1

59.6

71.5

‒12.6

0.095 0.006 5.76 7.43 9.61 20.5 8.6 62.9 — — — —

18.2 83.3

0.753 0.354 ‒0.111 1.55 (0.214)

Exercise, METS per week,d M (SE) Use of services Used women’s office, yes, % Recommended women’s office, yes, % Other Prevalence of obesity, %

1.65 (0.218)

2.44 (0.238)

2.45 (0.218)

SEs Difference in changesb Non- intensive controln=69 Intensive interventionn=65 Non- intensive controln=84 Intensive interventionn=83 Outcomea

Baseline

Table 3. Baseline and 6-Month Differences by Arm and Effects of the Intensive Intervention (continued)

6-month

p-valuec

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Food insecurity may have reduced more in the intensive intervention arm for 2 reasons. First, women learned how to eat healthily at low cost, use strategies to save money, and create a household budget to facilitate better management of existing resources. Although food insecurity comes from financial constraints,35 nutrition education can promote food security.36−38 Second, 38% of women in the intensive intervention arm who did not have a job obtained one, providing new financial resources to alleviate food insecurity. Women in the intensive intervention arm found a job more often than those in the nonintensive control arm. First, these women increased their psychological empowerment and developed new communication and other skills so they could be more secure to seek and accept jobs. Other interventions developing skills, education, and health of individuals allowed participants to seek better employment opportunities.38,39 Second, these women more frequently used and recommended services of the employability office of the Municipality. This office may have helped them to find a job for themselves and also for a household member. Women in the intensive intervention arm reduced BMI, weight, and obesity more than women in the nonintensive control arm. The reduction in weight (2.44 kg) in the intensive intervention arm was greater than that observed at 6 months in other studies with disadvantaged populations. For example, among obese, lowincome Latinos in San Mateo County, a case management intervention had weight loss of 1.6 kg and a combined case management and community worker intervention had 2.1 kg.40 In a 2-arm, 24-month randomized trial in Boston community health centers, at 6 months the weight loss difference between the intervention and the control arm was 1.11 kg.41 A study that offered behavioral weight loss combined with cognitive behavioral depression management to obese women who had depression achieved a 1.8-kg weight loss.42 Changes in weight may occur in part because of changes in consumption of foods such as salads, fried foods, sausages, and sugary drinks. Whereas a study in Mexico demonstrated that using cash and food transfers to decrease food insecurity may exacerbate weight particularly in obese women,19 this intervention reduced food insecurity and body weight. The intensive intervention did not affect social support for healthy eating, some food behaviors, and exercise. Except for social support for healthy eating, these outcomes also changed in the expected direction in the nonintensive arm, which may be because of the 3 educational sessions that women attended during which they appeared motivated to change their behaviors. www.ajpmonline.org

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Limitations Matched pairs of EBAISs were randomized to intervention arms, which were treated equivalently in pretesting and instrumentation. Anthropometric measurements were taken using standard protocols by trained enumerators. The food insecurity scale24 was validated in Costa Rica. The scales measuring secondary outcomes have been validated in Latin American countries but not in Costa Rica; questions may be not necessarily interpreted in the same way in Costa Rica, but before applying the scales the authors cognitively tested and revised them. Attrition was similar at 6 months but higher in the intensive intervention arm at 3 months, likely because of the intensity. Weekly sessions might have prevented women from attending all sessions and also women with greatest need from participating, especially because women experienced difficult living conditions. Women coped with severe food insecurity, difficulties in finding a job, being single mothers, dealing with children’s health and behavioral issues, mourning, imprisoned partners, overload of responsibilities including taking care of elderly and sick people, and in some cases a personal history of depression. Contamination between arms may have occurred despite the design. The geographical area is small, and some women in the intensive intervention arm might have had acquaintances or relatives in the nonintensive control arm and could have transferred some information, underestimating intervention effects.43 This study was conducted with food-insecure women with excess body weight in an urban area of Costa Rica. Findings may not be generalizable women with other characteristics but may be applicable to many Latin American countries that share similar characteristics such as social norms with Costa Rica.

CONCLUSIONS An intensive intervention for women was developed and implemented that simultaneously reduced food insecurity and weight by increasing their psychological and economic empowerment through education, promoting self-esteem and self-efficacy, and changing gendered behaviors in relation to co-responsibility and self-care. This intervention strategy is in contrast to solely providing food or cash transfers, which might contribute to excess body weight.17−19 Further research is needed to investigate if these results are sustained in the long term, changes in social support occur, the intervention strategy is generalizable to other countries with different cultural and economic characteristics, biweekly sessions increase attendance, and reduction of risk of cardiovascular disease is possible. & 2020

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ACKNOWLEDGMENTS The Office of International Affairs and the School of Nutrition of the University of Costa Rica supported this study. Assistance with implementation was provided by Adriana Murillo (School of Nutri~a and Grethel Bolan ~os (coordinators of the tion), Magaly Acun women’s and employability offices, respectively, of the Municipality of Alajuela) and Jeanette Vizcaíno (president of the Agenda de Mujeres). Several volunteers contributed to implement the study. Dr. Emily Mann reviewed an early version of the article. The study protocol was approved by the IRB at the University of South Carolina (IRB number: 00000204). No financial disclosures were reported by the authors of this paper.

SUPPLEMENTAL MATERIAL Supplemental materials associated with this article can be found in the online version at https://doi.org/10.1016/j. amepre.2019.11.021.

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