The MoMMii Study. Diabetes Prevention Intervention on Families With Past Gestational Diabetes

NCT02343354 | Completed

• 1 other identifier: GRT 2014-35
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Women with gestational diabetes (GDM) have increased risk of developing type 2 diabetes; their children show more insulin resistance and diabetes compared to offspring of mother without diabetes in pregnancy. An increased diabetes risk is also observed among partner of adult with prediabetes/type 2 diabetes. The investigators have pilot-tested a program for diabetes risk reduction among women within 5 years of a GDM pregnancy (MoMM program). The investigators are now enhancing the program to engage directly the partner (MoMMii program). In MoMMii, 66 couples with a history GDM in the mother will participate in a multimodal diabetes prevention program that includes healthy meal preparation training, discussion of eating and physical activity behaviours and developing home environments that facilitate healthy habits, pedometer-based step count monitoring, and participation in family-based activities (frisbee, soccer) as well as individual exercise (e.g., use of exercise equipment, floor resistance exercises). Participants will be encouraged to communicate between sessions with study personnel and with one another to create a between family support network. All mothers and fathers will participate in five sessions over six months. The investigators will examine changes in health-related behaviours, blood pressure, glucose levels, and insulin sensitivity/resistance in both mothers and fathers.

Conditions

Gestational Diabetes Mellitus With Baby Delivered

Keywords

behavioural; diabetes prevention; physical activity; healthy eating; gestational diabetes

Outcome Measures

Primary Outcomes (1)

• Change in post 75 gram glucose load 2-hour glucose value in mothers and fathers

  Following an overnight fast and venous blood sampling for fasting glucose, a 75 gram glucose solution will be consumed by the participant and two hours later, venous blood will be sampled for a repeat serum glucose assay. The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.

  20-24 weeks

Secondary Outcomes (8)

• Change in fruit and vegetable consumption in mothers and fathers

  20-24 weeks

• Change in physical activity in mothers and fathers

  20-24 weeks

• Change in insulin resistance measure (HOMA-IR) in mothers and fathers

  20-24 weeks

• Change in insulin sensitivity measure (ISI 0,120) in mothers and fathers

  20-24 weeks

• Change in fasting glucose in mothers and fathers

  20-24 weeks

Study Arms (1)

Nutrition/physical activity intervention

EXPERIMENTAL

There will be five in-person group sessions (3 to 4 weeks appart) with on-site child care. Sessions will include preparation of a healthy meal (hands-on) and discussions of mindful eating, balanced meals, portion sizes, and preparing food at home, under a dietitian's supervision. Sessions will also include a one-hour physical activity information/practice session with a kinesiologist. Participants will track daily step counts with a pedometer and aim to eventually reach more than 10,000 steps/day. They will also receive instruction and demonstration from a kinesiologist of some simple resistance exercises they may perform at home. Between sessions, participants will receive advice and support through a study-specific website, telephone calls and phone applications.

Behavioral: Nutrition/physical activity intervention

Interventions

Nutrition/physical activity intervention BEHAVIORAL

Please see arm description

Also known as: Lifestyle intervention, Diabetes prevention intervention

Nutrition/physical activity intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Prior history of gestational diabetes in the mother
• Ability to speak and read English or French

You may not qualify if:

• Other forms of diabetes (e.g., type 1 diabetes, type 2 diabetes)
• Current use of antihyperglycemic medication
• Pregnancy or attempting to become pregnant
• Chronic condition/ medications that could impact weight (e.g. malignancy, weight loss medications, anti-depressants)
• Current smoker

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• The Lawson Foundation: collaborator

Study Sites (1)

McGill University Health Centre - Royal Victoria Hosptial

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (4)

• Brazeau AS, Meltzer SJ, Pace R, Garfield N, Godbout A, Meissner L, Rahme E, Da Costa D, Dasgupta K. Health behaviour changes in partners of women with recent gestational diabetes: a phase IIa trial. BMC Public Health. 2018 May 2;18(1):575. doi: 10.1186/s12889-018-5490-x.

  PMID: 29716559 BACKGROUND

• Brazeau AS, Leong A, Meltzer SJ, Cruz R, DaCosta D, Hendrickson-Nelson M, Joseph L, Dasgupta K; MoMM study group. Group-based activities with on-site childcare and online support improve glucose tolerance in women within 5 years of gestational diabetes pregnancy. Cardiovasc Diabetol. 2014 Jun 30;13:104. doi: 10.1186/1475-2840-13-104.

  PMID: 24981579 BACKGROUND

• Leong A, Rahme E, Dasgupta K. Spousal diabetes as a diabetes risk factor: a systematic review and meta-analysis. BMC Med. 2014 Jan 24;12:12. doi: 10.1186/1741-7015-12-12.

  PMID: 24460622 BACKGROUND

• Dasgupta K, Da Costa D, Pillay S, De Civita M, Gougeon R, Leong A, Bacon S, Stotland S, Chetty VT, Garfield N, Majdan A, Meltzer S. Strategies to optimize participation in diabetes prevention programs following gestational diabetes: a focus group study. PLoS One. 2013 Jul 4;8(7):e67878. doi: 10.1371/journal.pone.0067878. Print 2013.

  PMID: 23861824 BACKGROUND

Related Links

• MoMM pilot study

MeSH Terms

Conditions

Motor Activity; Diabetes, Gestational

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Kaberi Dasgupta, MD, MSc

  McGill University and McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-Scientist and Director of Clinical Epidemiology, MUHC

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 22, 2015
• Study Start: November 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)