Avoiding Diabetes After Pregnancy Trial in Moms

NCT01918345 | Completed DMC

• 1 other identifier: ADAPT2013
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Diabetes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes, gestational; Prevention & control; Postpartum Period; Mothers; Diet; Diabetic Diet; Exercise; Life Style; Motivation; Health Behavior; Insulin-Secreting Cells; Randomized Controlled Trial; Clinical Trial; Pilot Projects; Feasibility Studies

Outcome Measures

Primary Outcomes (2)

• For the Pilot Phase: Change in baseline-adjusted pancreatic beta-cell function

  Beta-cell function will be measured using the Insulin Secretion Sensitivity Index 2 (ISSI-2), which is an established oral glucose tolerance test (OGTT)-based measure of beta-cell function that has been validated against the disposition index from intravenous glucose tolerance test (ivGTT) and has been used in previous clinical trials. ISSI-2 is the product of insulin secretion \[the ratio of area under-the-insulin-curve (AUCins) to area-under-the-glucose curve (AUCgluc)\] and insulin sensitivity measured by the Matsuda index: ISSI-2 = (AUCins / AUCgluc) × \[10000 / √(Fglu × Fins × Mglu × Mins)\] Where Fglu = fasting glucose; Fins = fasting insulin; Mglu = mean glucose; Mins = mean insulin These measures will be calculated using the glucose and insulin values at baseline, and at 60 and 120 minutes following a 75-gram oral glucose load.

  Assessed at week 1 (baseline) and week 24 (study end) of intervention

• For the Effectiveness Phase: Change in baseline-adjusted weight

  For the effectiveness phase weight is now the primary outcome and change in baseline-adjusted pancreatic beta-cell function a secondary outcome. Weight in kilograms (kg) will be measured using a medical grade scale at the baseline and final health assessment.. We will also measure height in metres (m) using a medical grade stadiometer to calculate body-mass index (BMI, kg/m2). We will analyze the weight and height outcomes as continuous variables. We will then categorize BMI as under/normal weight (\< 25 kg/m2), overweight (25.1-29.9 kg/m2), and obese (≥ 25 kg/m2). Finally, we will also calculate the proportion of participants who return to their pre-pregnancy weight or less, based on self-reported pre-pregnancy weight.

  Assessed at week 1 (baseline) and week 24 (study end) of intervention

Secondary Outcomes (1)

• Feasibility

  Assessed at week 12 (mid-study) and 24 (study end) of intervention

Other Outcomes (1)

• Behaviour change

  Assessed at week 1 (baseline) and week 24 (study end) of intervention

Study Arms (4)

Standard Care (Control)

NO INTERVENTION

This group will receive a one-on-one counseling session during one visit with a Certified Diabetes Educator (CDE), who will provide standard advice on diabetes prevention and healthy lifestyle. They will receive a booklet on exercise and healthy diet as per current Canadian guidelines for healthy eating. This group will also receive a check-in telephone call from the Study Coordinator, half-way through the study. This group will not receive motivational interviewing, health coaching on low GI diet and/or exercise, or additional telephone follow-up.

Diet & Physical Activity Program with Health Coach

EXPERIMENTAL

Participants assigned to this arm will receive a combination of the home-based physical activity program with health coach and the home-based low-GI diet program with health coach, as described in the respective individual arms. The Health Coach for this group will be a CDE.

Behavioral: Home-based Physical Activity Program with Health Coach; Behavioral: Home-based Low-GI Diet Program with Health Coach

Physical Activity Program with Health Coach

EXPERIMENTAL

Participants will be counseled to follow physical activity recommendations for Canadians, which is at least 150 minutes of moderate physical activity per week. Participants will be asked to participate in aerobic, strength training and stretching activities. Health Coaches will use motivational interviewing, goal-setting and problem solving to assist participants in meeting their physical activity goals. More participants will be randomized to this group and the participants will either have CDE or a Registered Kinesiologist (R. Kin) as their health coach.

Behavioral: Home-based Physical Activity Program with Health Coach

Diet Program with Health Coach

EXPERIMENTAL

Participants will be counseled to follow recommendations for Canadians on healthy eating (Canada's Food Guide and Space on Your Plate. Low GI education will be layered on top of Canada's Food Guide recommendations. The goal for participants in the diet group is to lower their dietary GI by 8-10 units. Health Coaches will use motivational interviewing, goal-setting and problem solving to assist participants in meeting their dietary and low GI goals. The health coach for this group will be a CDE.

Behavioral: Home-based Low-GI Diet Program with Health Coach

Interventions

Home-based Physical Activity Program with Health Coach BEHAVIORAL

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.

Diet & Physical Activity Program with Health Coach; Physical Activity Program with Health Coach

Home-based Low-GI Diet Program with Health Coach BEHAVIORAL

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.

Diet & Physical Activity Program with Health Coach; Diet Program with Health Coach

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Physician-diagnosed Gestational Diabetes Mellitus (GDM) during most recent pregnancy based on Canadian Diabetes Association (CDA) diagnostic criteria
• months postpartum after a GDM pregnancy
• During GDM pregnancy, followed by a Diabetes In Pregnancy clinic at one of study sites (i.e. Sunnybrook Health Sciences Centre, Mount Sinai Hospital, St. Michael's Hospital, Toronto East General Hospital)
• English-speaking

You may not qualify if:

• Current diabetes (Type I or Type II) and/or treatment with any anti-diabetic therapy
• Any major illness that may interfere with participation
• Any obstetrical or fetal complication that may interfere with participation
• Involvement in any other clinical trial requiring drug therapy
• History of cardiovascular disease or ECG abnormalities on stress echo cardiogram
• New pregnancy within postpartum period
• Any illness affecting carbohydrate digestion and/or metabolism including kidney disease, hepatitis, HIV/AIDS, celiac disease
• Any other factor likely to limit study adherence, in the opinion of the principal investigator
• (For the Effectiveness Phase ONLY) Participation in the Pilot Phase of the ADAPT-M Study

Sponsors & Collaborators

• Women's College Hospital: lead
• The Lawson Foundation: collaborator
• Diabetes Canada: collaborator
• Unity Health Toronto: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Mount Sinai Hospital, Canada: collaborator
• Michael Garron Hospital: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Scarborough Rouge Hospital: collaborator
• J.P. Bickell Foundation: collaborator

Study Sites (5)

Scarborough Health Network

Scarborough Village, Ontario, M1W 3W3, Canada

Location

Michael Garron Hospital

Toronto, Ontario, M4C 5M5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes, Gestational; Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Lorraine L Lipscombe, MD, MSc, FRCPC

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist, Research Scientist

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 7, 2013
• Study Start: July 1, 2014
• Primary Completion: October 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

CA (5)