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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Proportion achieving body weight goal
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Pregnancy at any point during the intervention period
研究组 & 干预措施
Lifestyle Modification Program
Women randomised into the intervention group received the 1-year lifestyle modification program.
干预措施: Lifestyle Modification Program (Behavioral)
Control
Women randomised into the control arm received standard postnatal care.
结局指标
主要结局
Proportion achieving body weight goal
时间窗: 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
次要结局
- 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)
研究者
Professor Ronald C.W. Ma
Professor
Chinese University of Hong Kong