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Families Defeating Diabetes (FDD)

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ClinicalTrials.gov Identifier: NCT01425645
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Diabetes Prevention Other: FDD program

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Families Defeating Diabetes: Canadian Intervention for Family-Centered Diabetes Prevention Following Gestational Diabetes (GDM)
Study Start Date : January 2012
Primary Completion Date : March 1, 2017
Study Completion Date : March 1, 2017
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Lifestyle and behavioural change support
Interventional arm will be offered a 12 month lifestyle program translating DM prevention issues to the family milieu
Other: FDD program
FDD is a 12 month lifestyle intervention and behavioural support program delivered in the context of the surrounding family
No Intervention: control
Control arm will receive standard diabetes prevention care as outlined in the current Canadian diabetes association Clinical Practice Guidelines.


Outcome Measures

Primary Outcome Measures :
  1. Proportion of study subjects achieving a 7% weight loss [ Time Frame: one year post-partum ]
    Weight loss in intervnetional vs control women will be documented by one year post-partum


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425645


Locations
Canada, Ontario
St Josephs Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
More Information

Responsible Party: Ruth McManus, MD, FRCPC, Cert Endo, Professor of Medicine, UWO, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01425645     History of Changes
Other Study ID Numbers: RXX
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by Ruth McManus, Lawson Health Research Institute:
gestational diabetes
GDM
prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications