Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus
HEALD-GDM
1 other identifier
interventional
100
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJanuary 17, 2018
July 1, 2016
2.1 years
May 28, 2015
January 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline to 6 months of moderate and vigorous physical activity (walking).
Accelerometer derived MVPA
6 months
Secondary Outcomes (1)
Change from baseline to 6 months in Low Glycemic Index foods.
6 months
Study Arms (2)
Control
NO INTERVENTIONIntervention
EXPERIMENTALLifestyle intervention with peer-counseling follow-up
Interventions
Eligibility Criteria
You may qualify if:
- laboratory confirmed previous and recent (within last 12 months) gestational diabetes mellitus • informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Athabasca University
Athabasca, Alberta, T9S 3A3, Canada
Alliance for Canadian Health Outcomes Research in Diabetes
Edmonton, Alberta, Canada
Related Publications (1)
Johnson ST, Mladenovic AB, Mathe N, Davenport MH, Butalia S, Qiu W, Johnson JA. Healthy eating and active living after gestational diabetes mellitus (HEALD-GDM): Rationale, design, and proposed evaluation of a randomized controlled trial. Contemp Clin Trials. 2017 Oct;61:23-28. doi: 10.1016/j.cct.2017.07.008. Epub 2017 Jul 9.
PMID: 28700892DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven T. Johnson, PhD
Athabasca University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 29, 2015
Study Start
June 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
January 17, 2018
Record last verified: 2016-07