A Randomized Clinical Trial Using a Postnatal Lifestyle Modification Program to Improve Diet, Adiposity and Metabolic Outcome in Mothers With Gestational Diabetes and Their Offspring
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Proportion achieving body weight goal
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The study aims to adapt a lifestyle modification program to engage GDM women early in the postnatal period to evaluate its effectiveness in reducing adiposity and metabolic parameters in the mother. Women will be randomized to receive a structured intervention or standard care.
Detailed Description
A complex intervention based on a proven lifestyle modification program (LMP) will be delivered to participants randomized to the intervention arm, starting in the early postnatal period. The intervention will consist of individualized face-to-face counseling on diet and weight management, meeting with exercise instructor, followed by telephone contact. Control will receive standard postnatal education materials and usual care provided by government health service.
Investigators
Professor Ronald C.W. Ma
Professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Women who developed gestational diabetes in their most recent pregnancy
- •GDM is diagnosed according to the WHO 2013 criteria of FBG ≥ 5.1mmol/l, or 1 hour glucose ≥10.0mmol/l, or 2 hour glucose ≥ 8.5mmol/l during 75g OGTT performed at 24-28 weeks of pregnancy
- •Singleton pregnancy
- •Reside normally in Hong Kong
- •Able to communicate in Chinese
- •Willing to give consent and follow study procedures
Exclusion Criteria
- •Subjects with pre-existing diabetes (T1D or T2D)
- •Subjects with life-threatening conditions including malignancy that is not in remission
- •Subjects with known psychiatric conditions including depression
- •Substance abuse or use of illicit substances
- •Subjects with significant renal impairment (eGFR\<60ml/min at baseline) or non-diabetic renal disease (e.g. biopsy-proven glomerulonephritis or obstructive uropathy)
- •Subjects on chronic corticosteroids treatment
- •Subjects with known myocardial infarction within the preceding 3 months
- •Major physical disability
- •Participation in other intervention trials
- •Surgical or medical interventions to treat obesity
Outcomes
Primary Outcomes
Proportion achieving body weight goal
Time Frame: Baseline, 12 months
3% body weight change at 12 months if pre-pregnant BMI ≥ 23kg/m2, or for those with pre-pregnant BMI \<23 kg/m2, either back to pre-pregnant weight or maintaining within BMI \<23 kg/m2
Secondary Outcomes
- Change in diabetes risk(Baseline, 12 months)
- Changes in fasting glucose(Baseline, 12 months)
- Changes in physical activity(Baseline, 12 months)
- Changes in quality of life indices(Baseline, 12 months)
- % of achieving dietary intervention goal(Baseline, 8weeks, 12 months)