Families Defeating Diabetes

Diabetes Prevention Clinical Trial

— FDD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425645
• Other study ID #: RXX
• Status: Completed
• Phase: N/A
• First received: August 27, 2011
• Last updated: September 11, 2017
• Start date: January 2012
• Est. completion date: March 1, 2017

Study information

• Verified date: September 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Prevention
• Diabetes, Gestational

Intervention

Other:
• FDD program
FDD is a 12 month lifestyle intervention and behavioural support program delivered in the context of the surrounding family

Locations

Country	Name	City	State
Canada	St Josephs Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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