Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus
Condition: Diabetes Mellitus Gestational Previous Pregnancy
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

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).
    

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.
    

Intervention name(s): Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus
Intervention type(s): Behavioral
Other intervention name(s): HEALD-GDM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention