Diabetes Mellitus Gestational Previous Pregnancy Clinical Trial
Official title:
Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus
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 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.
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