Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus (HEALD-GDM)

January 12, 2018 updated by: Steven T. Johnson, Athabasca University
To examine the effectiveness of a group-based lifestyle modification program followed by peer-led telephone counselling for type 2 diabetes (T2D) and cardiovascular disease risk reduction. The lifestyle modification program will support daily ambulatory activity and low glycemic index food intake among women with previous gestational diabetes mellitus (GDM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Objective:

To examine the effectiveness of a group-based lifestyle modification program followed by peer-led telephone counselling for type 2 diabetes (T2D) and cardiovascular disease risk reduction. The lifestyle modification program will support daily ambulatory activity and low glycemic index food intake among women with previous GDM.

Methods:

To achieve the study objective, the HEALD-GDM lifestyle modification program already proven effective for adults with T2D among women with previous GDM within 12 months postpartum will be evaluated. Women will take part in either the HEALD-GDM program (intervention) or in usual care (control). To evaluate the effectiveness of HEALD-GDM, a randomized, two-arm, before and after study design is proposed. Potentially eligible participants will be recruited from Diabetes in Pregnancy Clinics in Calgary and Edmonton, Alberta. Following identification of eligible participants, the investigators will randomize 100 participants to either the HEALD-GDM program or to usual care control (i.e., 50 per group). A Canadian Society of Exercise Physiology certified instructor (Exercise Specialist) trained in HEALD-GDM delivery will lead the program. Group-based classes will be held at community recreational centres in Calgary and Edmonton (one site each) in months one and four of the 24-week HEALD-GDM program. Theory-guided peer-led telephone counselling will supplement the program. HEALD-GDM focuses broadly on T2D prevention through lifestyle modification and will be based on a proven effective pedometer-based active living behaviour.

The primary outcome will be change in objectively measured moderate and vigorous physical activity at assessment appointments (baseline and 24 weeks). Secondary outcomes include: 1) body mass, 2) glycemic control (hemoglobin A1c), 3) musculoskeletal and cardiorespiratory fitness, 4) dietary intake, 5) metabolic biomarkers, 6) health-related quality of life (HRQL), social-cognitive mediators and 7) mental health.

Significance:

Evidence for appropriate lifestyle modification programs for this high-risk population is lacking. This study will serve to inform best practices for diabetes and cardiovascular disease risk reduction through known modifiable risk reduction targets such as healthy eating and active living.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Athabasca, Alberta, Canada, T9S 3A3
        • Athabasca University
      • Edmonton, Alberta, Canada
        • Alliance for Canadian Health Outcomes Research in Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • laboratory confirmed previous and recent (within last 12 months) gestational diabetes mellitus • informed consent

Exclusion Criteria:

  • unable to provide informed consent or unwilling to participate in the study
  • unable to read, understand and converse in English
  • contraindications based on the Canadian Society for Exercise Physiology Physical Activity Readiness Questionnaire Plus (PAR-Q+)
  • currently enrolled in other diabetes-related research studies
  • pregnant or planning another pregnancy in the next 12 months (any participants becoming pregnant at any point during the study will only contribute data prior to their pregnancy date)
  • hemoglobin A1c >6.5% or clinical suspicion of type 1 or type 2 diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Intervention
Lifestyle intervention with peer-counseling follow-up
Behavioral: Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus
Other Names:
  • HEALD-GDM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to 6 months of moderate and vigorous physical activity (walking).
Time Frame: 6 months
Accelerometer derived MVPA
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to 6 months in Low Glycemic Index foods.
Time Frame: 6 months
Low glycemic index food intake will be assessed using three-day food records.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Athabasca University

Investigators

  • Principal Investigator: Steven T. Johnson, PhD, Athabasca University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEALD-GDM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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