Families Defeating Diabetes

Not Applicable

Completed

• Conditions: Diabetes Prevention
• Interventions: Other: FDD program

• Registration Number: NCT01425645
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-27
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Study Start: 2012-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle and behavioural change support	FDD program	Interventional arm will be offered a 12 month lifestyle program translating DM prevention issues to the family milieu

Primary Outcome Measures

Name	Time	Method
Proportion of study subjects achieving a 7% weight loss	one year post-partum	Weight loss in intervnetional vs control women will be documented by one year post-partum

Trial Locations

Locations (1)

St Josephs Health Care; 🇨🇦 London, Ontario, Canada