Families Defeating Diabetes (FDD)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2011 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Ruth McManus, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01425645
First received: August 27, 2011
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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 Intervention
Diabetes Prevention
Other: FDD program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Families Defeating Diabetes: Canadian Intervention for Family-Centered Diabetes Prevention Following Gestational Diabetes (GDM)

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Proportion of study subjects achieving a 7% weight loss [ Time Frame: one year post-partum ] [ Designated as safety issue: No ]
    Weight loss in intervnetional vs control women will be documented by one year post-partum


Estimated Enrollment: 180
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425645

Contacts
Contact: Ruth M McManus, MD FRCPC Cert Endo 519-646-6371 ruth.mcmanus@sjhc.london.on.ca

Locations
Canada, Ontario
St Josephs Health Care Not yet recruiting
London, Ontario, Canada, N6A 4V2
Principal Investigator: Ruth M McManus, MD FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
  More Information

No publications provided

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
Study First Received: August 27, 2011
Last Updated: August 29, 2011
Health Authority: Belgium: Bridges group (International diabetes Federation)

Keywords provided by 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

ClinicalTrials.gov processed this record on August 21, 2014