None listed
Conditions
Brief summary
The primary aim of this study is to investigate the efficacy of simple lifestyle modification (healthy food choices and increased physical activity) in preventing excess weight gain during pregnancy (assessed 6 weeks postpartum). Secondary aims are to prevent prevalence of Gestational Diabetes Mellitus (GDM), identify barriers to healthy lifestyle choices and to provide an evidence base to inform future interventions targeting education and prevention of excess weight gain in the prevention of long-term obesity and prevention or treatment of Gestational Diabetes. The expected outcomes for this study include; 1/ Weight gain that is equal to, or below, recommended weight gain in the intervention group in comparison to the controls. 2/ Reduced prevalence of Gestational Diabetes and/or reduced intensity of treatment if diagnosis does occur in the intervention group. 3/ Lower incidence of increased foetal birth weight or macrosomia in the intervention group. 4/ Improved biological markers of health in the intervention group. 5/ Enhanced self-efficacy, motivation, mood and quality of life in the intervention group that persists long-term (1 year postpartum).
Interventions
Healthy lifestyle information (improved diet, exercise, behaviour modification) during duration of pregnancy. Information will delivered in the form of 4 interactive education modules that focus on healthy eating, regular moderate exercise, identifying and removing barriers to healthy lifestyle behaviours and improving self efficacy. Participants will also receive detailed written information on the content covered in the education modules. The 4 education modules will be delivered between 14
Healthy lifestyle information (improved diet, exercise, behaviour modification) during duration of pregnancy. Information will delivered in the form of 4 interactive education modules that focus on healthy eating, regular moderate exercise, identifying and removing barriers to healthy lifestyle behaviours and improving self efficacy. Participants will also receive detailed written information on the content covered in the education modules. The 4 education modules will be delivered between 14-16 to 26-28 weeks gestation (i.e. 1 module every 2-3 weeks).
Sponsors
Professor Helena Teede
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Women identified as high risk for developing GDM as indicated by the routine clinical risk screening tool at Southern Health within the first 12-14 weeks of pregnancy. Body Mass Index of above 25 kg/m2 (high ethnic risk groups) and above 27kgm2 (caucasion)
Exclusion criteria
Women who have Type 1 or Type 2 diabetes. Women not carrying singleton pregnancies. Women who have an existing chronic illness/disease or contra-indication that prevents or restricts their participation and/or exacerbates their condition when participating in moderate physical activity during pregnancy. Women who have a Body Mass Index of ³ 40kg/m2. Women who have an active psychiatric illness. Women who do not speak English/are not literate or who cannot attend the information session/s.
Outcome results
None listed