Families Defeating Diabetes
This trial is active, not recruiting.
|Sponsor||Lawson Health Research Institute|
|Start date||January 2012|
|End date||March 2017|
|Trial size||180 participants|
|Trial identifier||NCT01425645, RXX|
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.
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Proportion of study subjects achieving a 7% weight loss
time frame: one year post-partum
Male or female participants from 18 years up to 50 years old.
- women aged 18-50 with recent GDM
- able to speak and write English
- overweight (BMI >25 before pregnancy)
- significant other family members
- women with Types 1 or 2 diabetes
- women with BMI under 25
|Official title||Families Defeating Diabetes: Canadian Intervention for Family-Centered Diabetes Prevention Following Gestational Diabetes (GDM)|
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