Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2012-01-31
2017-03-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Lifestyle and behavioural change support
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
control
Control arm will receive standard diabetes prevention care as outlined in the current Canadian diabetes association Clinical Practice Guidelines.
No interventions assigned to this group
Interventions
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FDD program
FDD is a 12 month lifestyle intervention and behavioural support program delivered in the context of the surrounding family
Eligibility Criteria
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Inclusion Criteria
* able to speak and write English
* overweight (BMI \>25 before pregnancy)
* significant other family members
Exclusion Criteria
* women with BMI under 25
18 Years
50 Years
ALL
Yes
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Ruth McManus
MD, FRCPC, Cert Endo, Professor of Medicine, UWO
Locations
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St Josephs Health Care
London, Ontario, Canada
Countries
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Other Identifiers
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RXX
Identifier Type: -
Identifier Source: org_study_id
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