Families Defeating Diabetes (FDD)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Families Defeating Diabetes: Canadian Intervention for Family-Centered Diabetes Prevention Following Gestational Diabetes (GDM)|
- Proportion of study subjects achieving a 7% weight loss [ Time Frame: one year post-partum ] [ Designated as safety issue: No ]Weight loss in intervnetional vs control women will be documented by one year post-partum
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Lifestyle and behavioural change support
Interventional arm will be offered a 12 month lifestyle program translating DM prevention issues to the family milieu
Other: FDD program
FDD is a 12 month lifestyle intervention and behavioural support program delivered in the context of the surrounding family
No Intervention: control
Control arm will receive standard diabetes prevention care as outlined in the current Canadian diabetes association Clinical Practice Guidelines.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425645
|Contact: Ruth M McManus, MD FRCPC Cert Endofirstname.lastname@example.org|
|St Josephs Health Care||Not yet recruiting|
|London, Ontario, Canada, N6A 4V2|
|Principal Investigator: Ruth M McManus, MD FRCPC|