Families Defeating Diabetes (FDD)

This study is not yet open for participant recruitment.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 27, 2011

Last Updated Date

August 29, 2011

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01425645 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Families Defeating Diabetes

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Condition ^ICMJE

Diabetes Prevention

Intervention ^ICMJE

Other: FDD program

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

Study Arm (s)

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

Intervention: Other: FDD program
No Intervention: control
Control arm will receive standard diabetes prevention care as outlined in the current Canadian diabetes association Clinical Practice Guidelines.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

December 2014

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Ruth M McManus, MD FRCPC Cert Endo

519-646-6371

ruth.mcmanus@sjhc.london.on.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01425645

Other Study ID Numbers ^ICMJE

RXX

Has Data Monitoring Committee

Yes

Responsible Party

Ruth McManus, Lawson Health Research Institute

Study Sponsor ^ICMJE

Lawson Health Research Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Lawson Health Research Institute

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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