Avoiding Diabetes After Pregnancy Trial in Moms (ADAPT-M)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Women's College Hospital
Sponsor:
Collaborators:
The Lawson Foundation
Canadian Diabetes Association
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Mount Sinai Hospital, Canada
Toronto East General Hospital
Information provided by (Responsible Party):
Lorraine Lipscombe, Women's College Hospital
ClinicalTrials.gov Identifier:
NCT01918345
First received: July 31, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Diabetes
Behavioral: Home-based Exercise Program with Health Coach
Behavioral: Home-based Low-GI Diet Program with Health Coach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Avoiding Diabetes After Pregnancy Trial in Moms (ADAPT-M): Pilot and Feasibility Study

Resource links provided by NLM:


Further study details as provided by Women's College Hospital:

Primary Outcome Measures:
  • Change in baseline-adjusted pancreatic beta-cell function [ Time Frame: Assessed at week 1 (baseline) and week 24 (study end) of intervention ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Feasibility [ Time Frame: Assessed at week 24 (study end) of intervention ] [ Designated as safety issue: Yes ]
    Feasibility measures will include recruitment, pre- and post-randomization attrition, adherence and follow-up rates, and symptoms, side effects, and satisfaction of the interventions. Optimal feasibility will be defined as at least 40% recruitment of eligible population, maximum 30% attrition, and at least 80% follow-up assessment. Adherence to exercise will be assessed with the International Physical Activity Questionnaire (IPAQ) administered at baseline, mid-study (week 12 of intervention) and follow-up, which estimates whether activity guidelines are met based on metabolic equivalents (METs). Participant log books will be reviewed to assess diet and exercise adherence. Optimal adherence will be defined as meeting activity guidelines or consuming low GI foods at least 60% of the time for the exercise and diet arms respectively. Safety of interventions will also be assessed based on self-reported symptoms and side effects during telephone follow-up and at study end.


Other Outcome Measures:
  • Behaviour change [ Time Frame: Assessed at week 1 (baseline) and week 24 (study end) of intervention ] [ Designated as safety issue: No ]

    Exercise capacity: The primary endpoint for the exercise intervention will be baseline-adjusted exercise capacity at study end based on peak oxygen consumption (VO2max) from the graded exercise treadmill test. Change in metabolic equivalents (METs) and percent age-predicted fitness will also be calculated based on the Bruce protocol:

    % age-predicted fitness = (100×observed MET)/age-predicted MET, where MET = VO2max / 3.5

    Diet GI: The primary endpoint for the low GI diet intervention will be baseline-adjusted diet GI, which will be calculated using a three-day diet record using the following validated formula:

    Dietary GI = [ΣC×F×GI]/[ΣC×F]

    Where C=quantity of carbohydrate in age-specific portion of food; F=frequency of consumption/day; GI = GI of the food with glucose as the reference (GI=100).



Estimated Enrollment: 180
Study Start Date: June 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Health Counseling
This group will receive a one-on-one counseling session during one visit with a DEP counselor, 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 a CDE at Taddle Creek Family Health Team DEP half-way through the intervention, at three months (12 weeks). This group will not receive motivational interviewing, health coaching on low GI diet and/or exercise, or additional telephone follow-up.
Experimental: Diet & Exercise Program with Health Coach
Participants assigned to this arm will receive a combination of the home-based exercise program with health coach and the home-based low-GI diet program with health coach, as described in the respective individual arms.
Behavioral: Home-based Exercise Program with Health Coach
This arm will receive a trained diabetes education program (DEP) health coach and a home-based exercise program for 24 weeks. Health coaches will provide one-on-one motivational interviewing (MI) and a customized exercise prescription that incorporates goal-setting, and accounts 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 review activity logs and advance goals. Phone-calls will be administered on a weekly basis during weeks 1-8 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 diabetes education program (DEP) health coach and a home-based low-GI diet program for 24 weeks. Health coach 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 review dietary logs and advance goals. Phone-calls will be administered on a weekly basis during weeks 1-8 of the intervention, biweekly basis on weeks 10-12, and monthly basis on weeks 16-24.
Experimental: Exercise Program with Health Coach
Participants in this arm will receive a customized home-based exercise program with health coach for 24 study weeks. Health coaches will provide women with an exercise prescription that accounts for participants' baseline fitness and current lifestyle demands, and is based on minimum recommendations for moderate-intensity exercise for postpartum women, as exercise at a moderate intensity has been shown to be as effective as high-intensity activity in increasing exercise capacity in new mothers. This arm will receive regular phone-based motivational interviewing (MI) from their health coaches.
Behavioral: Home-based Exercise Program with Health Coach
This arm will receive a trained diabetes education program (DEP) health coach and a home-based exercise program for 24 weeks. Health coaches will provide one-on-one motivational interviewing (MI) and a customized exercise prescription that incorporates goal-setting, and accounts 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 review activity logs and advance goals. Phone-calls will be administered on a weekly basis during weeks 1-8 of the intervention, biweekly basis on weeks 10-12, and monthly basis on weeks 16-24.
Experimental: Diet Program with Health Coach
Participants in this arm will receive a customized home-based low-GI diet program with health coach for 24 study weeks. Health coaches will advise women to follow current Canadian nutritional guidelines to support healthy lactation and provide advice to reduce average daily dietary GI by 8-10 units, incorporating personal dietary preferences, food allergies, aversions and traditional/cultural foods. Low GI education will be layered on top of current standard care (Canadian nutritional guidelines for adults). This arm will receive regular phone-based motivational interviewing (MI) from their health coaches to review dietary logs and advance goals.
Behavioral: Home-based Low-GI Diet Program with Health Coach
This arm will receive a trained diabetes education program (DEP) health coach and a home-based low-GI diet program for 24 weeks. Health coach 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 review dietary logs and advance goals. Phone-calls will be administered on a weekly basis during weeks 1-8 of the intervention, biweekly basis on weeks 10-12, and monthly basis on weeks 16-24.

Detailed Description:

Women diagnosed with gestational diabetes mellitus (GDM) are a readily identifiable population at high risk for type 2 diabetes (T2DM) to whom preventive interventions can be offered. There is evidence that T2DM can be prevented with lifestyle modification in older high-risk risk groups. However, preventive trials for women with recent GDM have had limited success in preventing T2DM, in part because they have failed to produce significant behaviour change. New mothers are a unique population with many competing demands and barriers to behaviour change. Home-based health coaching programs may be more effective in women with recent GDM, as they provide greater flexibility, goal-setting, and frequent follow-up, and have been associated with greater adherence and weight loss. Low glycemic-index diets are also associated with greater adherence and improved glycemia, but data are lacking in women with recent GDM.

The ADAPT-M (Avoiding Diabetes after Pregnancy Trial in moms) study will address these gaps by evaluating a home-based exercise and diet intervention that has been designed specifically for new mothers with recent GDM. An internationally renowned team of investigators and collaborators was brought together to create this intervention. This trial has been carefully designed based on our previous work, an extensive literature review, and the input from co-investigators with expertise in diabetes research, gestational diabetes, prenatal and postpartum care, diabetes education programs, home-based exercise coaching, nutrition and diet interventions, and clinical trials. Investigators will work closely with the Clinical Trials Unit of the Applied Health Research Centre (AHRC) of University of Toronto to develop, implement, and evaluate this trial.

This study is important because it addresses a crucial missed opportunity for diabetes prevention in a well-defined, high-risk population. This intervention is unique because it has been specifically tailored to optimize behaviour change by meeting the needs of new mothers. The findings from this study will have implications for diabetes caregivers, policy-makers, and researchers. This work will benefit women with prior GDM and their families by offering a much-needed effective and sustainable program aimed at reducing their risk of diabetes and improving long-term health.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Physician-diagnosed Gestational Diabetes Mellitus (GDM) during most recent pregnancy based on Canadian Diabetes Association (CDA) diagnostic criteria
  • 3-6 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

Exclusion Criteria:

  • 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 graded exercise treadmill test
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918345

Contacts
Contact: Andrea Glenn, MSc, RD 416-351-3732 ext 2321 andrea1.glenn@wchospital.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Julia Lowe, MB.ChB, MSc, FRCP    416-480-6948    julia.lowe@sunnybrook.ca   
Sub-Investigator: Julia Lowe, MB.ChB, MSc, FRCP         
Sponsors and Collaborators
Women's College Hospital
The Lawson Foundation
Canadian Diabetes Association
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Mount Sinai Hospital, Canada
Toronto East General Hospital
Investigators
Principal Investigator: Lorraine L Lipscombe, MD, MSc, FRCPC Women's College Hospital
  More Information

No publications provided

Responsible Party: Lorraine Lipscombe, Endocrinologist, Research Scientist, Women's College Hospital
ClinicalTrials.gov Identifier: NCT01918345     History of Changes
Other Study ID Numbers: ADAPT2013
Study First Received: July 31, 2013
Last Updated: June 18, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Women's College Hospital:
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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014