Avoiding Diabetes After Pregnancy Trial in Moms

Summary

Mothers with previous gestational diabetes mellitus (GDM) represent a population at higher risk of future Type 2 diabetes mellitus (T2DM), which is preventable through lifestyle modification. Yet, no formal prevention programs exist for this population. The postpartum period is a particularly vulnerable period for weight gain and unhealthy lifestyle in new mothers due to their competing demands of childcare and breastfeeding. This important time period may thus represent a 'window of opportunity' for women with previous GDM, whereby interventions to improve their lifestyle can be offered. Eligible women will be recruited during pregnancy from four hospitals and invited to participate in a home-based lifestyle intervention program starting from three to six months postpartum. This pilot study will investigate the feasibility and effectiveness of a physical activity and diet intervention. It will also explore the relationship between behaviour change and metabolic markers of T2DM in this high-risk population. Investigators hypothesize that the ADAPT-M program will be feasible and will be associated with an improvement in metabolic T2DM markers, as well as a high rate of satisfaction, adherence, and effectiveness.

Conditions

• Diabetes

Interventions

BEHAVIORAL

Home-based Physical Activity Program with Health Coach

This arm will receive either a trained CDE or R. Kin as a health coach and a home-based physical activity program for 6 months. Health coaches will provide one-on-one motivational interviewing (MI) and goal-setting, and will account for baseline fitness, resources, childcare, and breastfeeding, to be undertaken at participants' homes or in their communities. Prescriptions will be based on minimum recommendations for moderate-intensity exercise for postpartum women. Participants will maintain at least 150 min/week of moderate activity at a target heart rate of 30-80% with a perceived exertion of 12-15 on the Borg Scale. They will also be counseled on resistance training and pelvic floor exercises. They will receive regular telephone-based coaching to advance goals. Phone-calls will be administered on a weekly basis during weeks 2-8 of the intervention, biweekly basis on weeks 10-12, and monthly basis on weeks 16-24.

BEHAVIORAL

Home-based Low-GI Diet Program with Health Coach

This arm will receive a trained CDE health coach and a home-based low-GI diet program for 6 months. Health coaches will provide baseline education during a one-on-one visit and use MI to introduce the dietary intervention. Low GI education will be layered on top of current standard care, which asks women to consume a diet comprised of 45-65% carbohydrates (25 g of dietary fibre), 10-30% protein, and 25-35% fat. As per standard care at the DEPs, this intake will be divided into 3 meals and 2 to 4 snacks. Resources for women will include a low GI dietary food substitution list, a recipe booklet, and a tip sheet on how to lower dietary GI. Women will receive regular telephone-based coaching to advance goals. Phone-calls will be administered on a weekly basis during weeks 2-8 of the intervention, biweekly basis on weeks 10-12, and monthly basis on weeks 16-24.

Sponsors & Collaborators

• The Lawson Foundation

  collaborator OTHER

• Diabetes Canada

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• Mount Sinai Hospital, Canada

  collaborator OTHER

• Michael Garron Hospital

  collaborator OTHER

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Scarborough Rouge Hospital

  collaborator OTHER

• J.P. Bickell Foundation

  collaborator UNKNOWN

• Women's College Hospital

  lead OTHER

Principal Investigators

• Lorraine L Lipscombe, MD, MSc, FRCPC · Women's College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2022-10-31

Completion

2023-01-31

Countries

• Canada

Study Locations