This trial is active, not recruiting.

Condition diabetes prevention
Treatment fdd program
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
(Active Comparator)
Interventional arm will be offered a 12 month lifestyle program translating DM prevention issues to the family milieu
fdd program
FDD is a 12 month lifestyle intervention and behavioural support program delivered in the context of the surrounding family
(No Intervention)
Control arm will receive standard diabetes prevention care as outlined in the current Canadian diabetes association Clinical Practice Guidelines.

Primary Outcomes

Proportion of study subjects achieving a 7% weight loss
time frame: one year post-partum

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title Families Defeating Diabetes: Canadian Intervention for Family-Centered Diabetes Prevention Following Gestational Diabetes (GDM)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.