- Email: [email protected]
Intervention outcomes from a randomised controlled trial of diabetes prevention: Mothers after Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP)
Oral Presentations / Diabetes Research and Clinical Practice 120S1 (2016) S40–S64
S59
Conclusion: Our results indicate the healthy behaviors modification, an essential component in diabetes management, can be effectively strengthened by multidisciplinary care in the accredited diabetes management program. Without health education and dietetic consultation, the usual medical care provided by physicians alone is hard to optimize diabetes care, especially in bettering glycemic control, normalizing triglyceride level and changing healthy lifestyle.
The MAGDA-DPP study demonstrates a modest effect of the intervention in women with prior GDM diagnosis. Although 1kg weight difference is likely to be significant for reducing diabetes risk, the engagement effort required during the first postnatal year is not sustainable in routine health services. It is recommended to implement annual diabetes screening until post-GDM women develop IGT or IFG, before offering an intervention.
OL08-5 Intervention outcomes from a randomised controlled trial of diabetes prevention: Mothers after Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) Sophy TF SHIH1, Sharleen O’REILLY2, Vincent VERSACE3, Edward JANUS4, Timothy SKINNER5, John REYNOLDS6, Carol WILDEY1, Rob CARTER1, James BEST7, Jeremy OATS8, Michael ACKLAND9, Paddy PHILLIPS10, James DUNBAR1, On Behalf of the MAGDA Study Group1. 1Centre for Population Health Research, Faculty of Health, Deakin University, 2Institute of Physical Activity and Nutrition Research, Deakin University, 3Greater Green Triangle Department of Rural Health, Flinders University and Deakin University, 4Department of Medicine, University of Melbourne and Western Health, Sunshine Hospital, St Albans, Victoria, 5School of Psychological and Clinical Sciences, Charles Darwin University, 6 Alfred Health and Faculty of Medicine, Nursing and Health Sciences, Monash University, Australia; 7Lee Kong Chian School of Medicine, Imperial College London and Nanyang Technological University, Singapore; 8Melbourne School of Population and Global Health, University of Melbourne, 9Department of Epidemiology and Preventive Medicine, Monash University, 10Department of Medicine, Flinders University and SA Health, Australia
OL08-6 Program engagement in a randomised controlled trial for diabetes prevention: Mothers after Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) Sophy TF SHIH1, Carol WILDEY1, Vincent VERSACE2, Sharleen O’REILLY3, Rob CARTER1, Edward JANUS4, Timothy SKINNER5, James DUNBAR1, On Behalf of the MAGDA Study Group1. 1Centre for Population Health Research, Faculty of Health, Deakin University, 2Greater Green Triangle Department of Rural Health, Flinders University and Deakin University, 3Institute of Physical Activity and Nutrition Research, Deakin University, 4Department of Medicine, University of Melbourne and Western Health, Sunshine Hospital, St Albans, Victoria, 5School of Psychological and Clinical Sciences, Charles Darwin University, Australia
Incidence of gestational diabetes mellitus (GDM) and type 2 diabetes (T2DM) is increasing worldwide posing an immense burden to healthcare systems. Women with GDM diagnosis have a life-time risk exceeding 70% of developing T2DM. The Mothers after Gestational Diabetes in Australia (MAGDA) study was a randomised controlled trial aiming to assess the effectiveness of a group-based lifestyle modification program for women with GDM diagnosis in their first postnatal year. A total of 573 women were randomised to either the intervention group (n = 284) receiving a structured diabetes prevention program or the control group (n = 289) receiving usual care. The diabetes prevention intervention comprised of 1 individual and 5 group face-to-face sessions delivered by trained healthcare professionals followed by 2 additional follow-up telephone calls. The primary outcome was changes in diabetes risk determined by weight, waist and fasting plasma glucose (FPG). The secondary outcomes included changes in behavioural goals, depression score, and cardiovascular disease risk factors. These outcomes were assessed at baseline and 12 months for all participating women and additionally at 3 months for the intervention participants only. At baseline, 28% and 38% of participants were overweight or obese respectively, while only 10% participants had impaired glucose tolerance (IGT) and 2% impaired fasting glucose (IFG). Results of intention to treat (ITT) analysis show, at 12 months, the intervention groups’ average weight loss was 0.23 kg (95% CI −0.89, 0.43) compared with weight gain of 0.72 kg (95% CI 0.09, 1.35) in the usual care control group. The change difference between groups over 12 months was statistically significant, with 0.95 kg weight loss in the intervention group (95% CI −1.87, −0.14, group by treatment intervention p = 0.04). At three months, the intervention group had lost 0.92 kg ( p = 0.001) compared to the baseline levels. Other significant outcomes at three months were reduction in waist circumference, total cholesterol, high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) (all p < 0.001) in the intervention group. Reduction in waist circumference, total cholesterol and LDL-C were maintained at 12 months, but not the reduction in weight and HDL-C.
Women with gestational diabetes (GDM) are at sevenfold increased risk of developing type 2 diabetes compared with women without GDM. The Mothers after Gestational Diabetes in Australia (MAGDA) study was a multicentre randomized controlled trial assessing the effectiveness of a structured diabetes prevention program (DPP) for women with previous GDM in their first postnatal year. The MAGDA-DPP intervention comprised 1 individual and 5 group sessions delivered by trained healthcare professionals, with 2 follow-up telephone calls. Women aged over 18 years diagnosed with GDM in their most recent pregnancy were recruited using multiple strategies: (i) an antenatal clinic appointment approach (4 metropolitan hospitals); (ii) a postnatal private obstetrician invitation letter; and (iii) a postnatal invitation letter through the National Gestational Diabetes Register (NGDR) to selected postcodes. NGDR-recruited participants were older (p < 0.001) and the babies of women recruited antenatally were younger than the other recruitment methods ( p < 0.001). On average, recruiters spent 22 minutes per woman assessing interest and eligibility. ANOVA results showed no difference in recruitment efforts (number of contacts, time and staff cost) across different recruitment strategies. Recruitment success rates did differ; with the NGDR being the most successful strategy (149/191, 74%), followed by postnatal invitation (36/77, 47%) and antenatal approach (402/1972, 20%) (p < 0.001). Among women randomized to the intervention (n = 284), 66% (n = 188) completed ≥1 session. More specifically, 13% had only an individual session (IS) (n = 37), 53% completed the individual session plus ≥1 group session(s) (GS) (program minimum standard, n = 149), with only 10% completing all 6 sessions (n = 28). 34% of women randomised had no exposure (n = 96), despite an average of 4 contact attempts made by facilitators. On average, group facilitators spent 18 minutes per intervention participant arranging and reminding women about intervention sessions. Of those participants achieving the program minimum standard, the average attendance was 3 sessions, with facilitators averaging 20 minutes with 10 contacts to achieve this. ANOVA tests showed no difference in retention efforts between intervention participants recruited by different strategies. Program attendance by women recruited through antenatal approach, however, was significantly lower than other recruitment methods [IS only (p = 0.04), IS plus ≥1 GS (p = 0.01), and IS plus ≥3 GS (p < 0.001)].
S59
Conclusion: Our results indicate the healthy behaviors modification, an essential component in diabetes management, can be effectively strengthened by multidisciplinary care in the accredited diabetes management program. Without health education and dietetic consultation, the usual medical care provided by physicians alone is hard to optimize diabetes care, especially in bettering glycemic control, normalizing triglyceride level and changing healthy lifestyle.
The MAGDA-DPP study demonstrates a modest effect of the intervention in women with prior GDM diagnosis. Although 1kg weight difference is likely to be significant for reducing diabetes risk, the engagement effort required during the first postnatal year is not sustainable in routine health services. It is recommended to implement annual diabetes screening until post-GDM women develop IGT or IFG, before offering an intervention.
OL08-5 Intervention outcomes from a randomised controlled trial of diabetes prevention: Mothers after Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) Sophy TF SHIH1, Sharleen O’REILLY2, Vincent VERSACE3, Edward JANUS4, Timothy SKINNER5, John REYNOLDS6, Carol WILDEY1, Rob CARTER1, James BEST7, Jeremy OATS8, Michael ACKLAND9, Paddy PHILLIPS10, James DUNBAR1, On Behalf of the MAGDA Study Group1. 1Centre for Population Health Research, Faculty of Health, Deakin University, 2Institute of Physical Activity and Nutrition Research, Deakin University, 3Greater Green Triangle Department of Rural Health, Flinders University and Deakin University, 4Department of Medicine, University of Melbourne and Western Health, Sunshine Hospital, St Albans, Victoria, 5School of Psychological and Clinical Sciences, Charles Darwin University, 6 Alfred Health and Faculty of Medicine, Nursing and Health Sciences, Monash University, Australia; 7Lee Kong Chian School of Medicine, Imperial College London and Nanyang Technological University, Singapore; 8Melbourne School of Population and Global Health, University of Melbourne, 9Department of Epidemiology and Preventive Medicine, Monash University, 10Department of Medicine, Flinders University and SA Health, Australia
OL08-6 Program engagement in a randomised controlled trial for diabetes prevention: Mothers after Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) Sophy TF SHIH1, Carol WILDEY1, Vincent VERSACE2, Sharleen O’REILLY3, Rob CARTER1, Edward JANUS4, Timothy SKINNER5, James DUNBAR1, On Behalf of the MAGDA Study Group1. 1Centre for Population Health Research, Faculty of Health, Deakin University, 2Greater Green Triangle Department of Rural Health, Flinders University and Deakin University, 3Institute of Physical Activity and Nutrition Research, Deakin University, 4Department of Medicine, University of Melbourne and Western Health, Sunshine Hospital, St Albans, Victoria, 5School of Psychological and Clinical Sciences, Charles Darwin University, Australia
Incidence of gestational diabetes mellitus (GDM) and type 2 diabetes (T2DM) is increasing worldwide posing an immense burden to healthcare systems. Women with GDM diagnosis have a life-time risk exceeding 70% of developing T2DM. The Mothers after Gestational Diabetes in Australia (MAGDA) study was a randomised controlled trial aiming to assess the effectiveness of a group-based lifestyle modification program for women with GDM diagnosis in their first postnatal year. A total of 573 women were randomised to either the intervention group (n = 284) receiving a structured diabetes prevention program or the control group (n = 289) receiving usual care. The diabetes prevention intervention comprised of 1 individual and 5 group face-to-face sessions delivered by trained healthcare professionals followed by 2 additional follow-up telephone calls. The primary outcome was changes in diabetes risk determined by weight, waist and fasting plasma glucose (FPG). The secondary outcomes included changes in behavioural goals, depression score, and cardiovascular disease risk factors. These outcomes were assessed at baseline and 12 months for all participating women and additionally at 3 months for the intervention participants only. At baseline, 28% and 38% of participants were overweight or obese respectively, while only 10% participants had impaired glucose tolerance (IGT) and 2% impaired fasting glucose (IFG). Results of intention to treat (ITT) analysis show, at 12 months, the intervention groups’ average weight loss was 0.23 kg (95% CI −0.89, 0.43) compared with weight gain of 0.72 kg (95% CI 0.09, 1.35) in the usual care control group. The change difference between groups over 12 months was statistically significant, with 0.95 kg weight loss in the intervention group (95% CI −1.87, −0.14, group by treatment intervention p = 0.04). At three months, the intervention group had lost 0.92 kg ( p = 0.001) compared to the baseline levels. Other significant outcomes at three months were reduction in waist circumference, total cholesterol, high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) (all p < 0.001) in the intervention group. Reduction in waist circumference, total cholesterol and LDL-C were maintained at 12 months, but not the reduction in weight and HDL-C.
Women with gestational diabetes (GDM) are at sevenfold increased risk of developing type 2 diabetes compared with women without GDM. The Mothers after Gestational Diabetes in Australia (MAGDA) study was a multicentre randomized controlled trial assessing the effectiveness of a structured diabetes prevention program (DPP) for women with previous GDM in their first postnatal year. The MAGDA-DPP intervention comprised 1 individual and 5 group sessions delivered by trained healthcare professionals, with 2 follow-up telephone calls. Women aged over 18 years diagnosed with GDM in their most recent pregnancy were recruited using multiple strategies: (i) an antenatal clinic appointment approach (4 metropolitan hospitals); (ii) a postnatal private obstetrician invitation letter; and (iii) a postnatal invitation letter through the National Gestational Diabetes Register (NGDR) to selected postcodes. NGDR-recruited participants were older (p < 0.001) and the babies of women recruited antenatally were younger than the other recruitment methods ( p < 0.001). On average, recruiters spent 22 minutes per woman assessing interest and eligibility. ANOVA results showed no difference in recruitment efforts (number of contacts, time and staff cost) across different recruitment strategies. Recruitment success rates did differ; with the NGDR being the most successful strategy (149/191, 74%), followed by postnatal invitation (36/77, 47%) and antenatal approach (402/1972, 20%) (p < 0.001). Among women randomized to the intervention (n = 284), 66% (n = 188) completed ≥1 session. More specifically, 13% had only an individual session (IS) (n = 37), 53% completed the individual session plus ≥1 group session(s) (GS) (program minimum standard, n = 149), with only 10% completing all 6 sessions (n = 28). 34% of women randomised had no exposure (n = 96), despite an average of 4 contact attempts made by facilitators. On average, group facilitators spent 18 minutes per intervention participant arranging and reminding women about intervention sessions. Of those participants achieving the program minimum standard, the average attendance was 3 sessions, with facilitators averaging 20 minutes with 10 contacts to achieve this. ANOVA tests showed no difference in retention efforts between intervention participants recruited by different strategies. Program attendance by women recruited through antenatal approach, however, was significantly lower than other recruitment methods [IS only (p = 0.04), IS plus ≥1 GS (p = 0.01), and IS plus ≥3 GS (p < 0.001)].