Families Defeating Diabetes

Study Overview
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Brief Summary
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No evidence-based, evaluated, population-appropriate resources exist to translate Type 2 diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such large-scale interventions include: the need to identify, then target specific at-risk populations significant time-delays before any program effects on T2DM incidence may manifest. However, women with gestational diabetes (GDM) are a readily identifiable study cohort at significant risk for recurrent GDM and T2DM-hence GDM women provide important opportunities for rigorous, timely diabetes prevention intervention studies. The investigators propose FDD (Families Defeating Diabetes), a Canadian diabetes prevention intervention uniquely targeting women with recent GDM in the context of their families. FDD is a 12 month, randomized, controlled T2DM prevention intervention targeting women with recent GDM, within their family context. Five Canadian sites and 177 women will participate. Multifaceted information and behavioural change support will be provided for diet, weight loss, and activity through: seminar, walking groups, electronic updates, password-protected social networking site. Subjects and controls will be compared for: DM prevention knowledge; diet/activity choices; HbA1C; body habitus at study onset/during study/12 months/24 months. Consenting immediate family members will have protective knowledge/diet/exercise choices/body habitus measures documented at study onset/12 and 24 months.

Official Title
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Families Defeating Diabetes: Canadian Intervention for Family-Centered Diabetes Prevention Following Gestational Diabetes (GDM)

Conditions
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Diabetes Prevention

Intervention / Treatment
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* Other: FDD program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women aged 18-50 with recent GDM able to speak and write English overweight (BMI >25 before pregnancy) significant other family members Exclusion Criteria: women with Types 1 or 2 diabetes women with BMI under 25

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle and behavioural change support<br>Interventional arm will be offered a 12 month lifestyle program translating DM prevention issues to the family milieu | Other: FDD program<br>* FDD is a 12 month lifestyle intervention and behavioural support program delivered in the context of the surrounding family<br>|
| No Intervention: control<br>Control arm will receive standard diabetes prevention care as outlined in the current Canadian diabetes association Clinical Practice Guidelines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of study subjects achieving a 7% weight loss | Weight loss in intervnetional vs control women will be documented by one year post-partum | one year post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, GDM, prevention