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Home-based Low-GI Diet Program with Health Coach for Diabetes (ADAPT-M Trial)

N/A
Waitlist Available
Led By Lorraine L Lipscombe, MD, MSc, FRCPC
Research Sponsored by Women's College Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at week 12 (mid-study) and 24 (study end) of intervention
Awards & highlights

ADAPT-M Trial Summary

This trial is investigating whether a physical activity and diet intervention can help improve the lifestyle of mothers with a history of gestational diabetes, in order to prevent them from developing Type 2 diabetes later in life.

Eligible Conditions
  • Diabetes

ADAPT-M Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at week 12 (mid-study) and 24 (study end) of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at week 12 (mid-study) and 24 (study end) of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
For the Effectiveness Phase: Change in baseline-adjusted weight
For the Pilot Phase: Change in baseline-adjusted pancreatic beta-cell function
Secondary outcome measures
Feasibility
Other outcome measures
Behaviour change

ADAPT-M Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Physical Activity Program with Health CoachExperimental Treatment1 Intervention
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.
Group II: Diet Program with Health CoachExperimental Treatment1 Intervention
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.
Group III: Diet & Physical Activity Program with Health CoachExperimental Treatment2 Interventions
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.
Group IV: Standard Care (Control)Active Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home-based Physical Activity Program with Health Coach
2014
N/A
~350
Home-based Low-GI Diet Program with Health Coach
2014
N/A
~350

Find a Location

Who is running the clinical trial?

Women's College HospitalLead Sponsor
100 Previous Clinical Trials
38,458 Total Patients Enrolled
1 Trials studying Diabetes
175 Patients Enrolled for Diabetes
The Lawson FoundationOTHER
15 Previous Clinical Trials
3,637 Total Patients Enrolled
Diabetes CanadaOTHER
10 Previous Clinical Trials
762 Total Patients Enrolled

Frequently Asked Questions

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~32 spots leftby Apr 2025