Families Defeating Diabetes

NCT01425645 | Completed DMC

• 1 other identifier: RXX
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Prevention

Keywords

gestational diabetes; GDM; prevention

Outcome Measures

Primary Outcomes (1)

• Proportion of study subjects achieving a 7% weight loss

  Weight loss in intervnetional vs control women will be documented by one year post-partum

  one year post-partum

Study Arms (2)

Lifestyle and behavioural change support

ACTIVE COMPARATOR

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

Other: FDD program

control

NO INTERVENTION

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

Interventions

FDD program OTHER

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

Lifestyle and behavioural change support

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women aged 18-50 with recent GDM
• able to speak and write English
• overweight (BMI \>25 before pregnancy)
• significant other family members

You may not qualify if:

• women with Types 1 or 2 diabetes
• women with BMI under 25

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St Josephs Health Care

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC, Cert Endo, Professor of Medicine, UWO

Study Record Dates

• First Submitted: August 27, 2011
• First Posted: August 30, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

CA (1)