Families Defeating Diabetes (FDD)

Lawson Health Research Institute

Status: Completed

Conditions: Diabetes Prevention

Treatments: Other: FDD program

Study type: Interventional

Funder types: Other

Identifiers

NCT01425645

RXX

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Lifestyle and behavioural change support

Active Comparator group

Description:

Interventional arm will be offered a 12 month lifestyle program translating DM prevention issues to the family milieu

Treatment:

Other: FDD program

control

No Intervention group

Description:

Control arm will receive standard diabetes prevention care as outlined in the current Canadian diabetes association Clinical Practice Guidelines.