A Lifestyle Intervention Program for the Prevention of Type 2 Diabetes Mellitus Among South Asian Women With Prior Gestational Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,612
- 试验地点
- 20
- 主要终点
- Proportion of women with a change of glycaemic category, at or prior to final visit
研究概览
简要总结
Investigators have taken the learning from various programs to develop a new lifestyle program (LIVING) that has a high probability of being feasible, acceptable and cost-effective in the South Asian context for women with prior Gestational Diabetes Mellitus (GDM). Investigators will optimize this intervention using an iterative, systems-based and user-centered approach. The intervention will be delivered by auxiliary nurse midwives or their equivalent in each participating hospital, representing a strategy of within-system task-shifting to augment scalability and sustainability. Investigators will then evaluate this in a Randomised Controlled Trial (RCT) to determine whether it will reduce the incidence of Type 2 Diabetes Mellitus (T2DM), in a manner that is affordable, acceptable and scalable. This project focuses on generating new knowledge around implementation of a preventive strategy embedded within existing health systems, using mixed-methods evaluation to inform on cost-effectiveness, acceptability and scalability. It represents a case study into "Integrated Innovation TM" incorporating a science component (a program based on behavior change theory that supports a multi-level approach to prevention by combining individually targeted strategies with social support), a social component (an innovative workforce strategy) and a sustainability component (a systems perspective for integration with existing health system infrastructure).
详细描述
Burden: Diabetes Mellitus is a major public health concern for both the developed and the developing countries. Globally 246 million people are affected with diabetes, and this will rise to 300 million by 2025. In India, around 25% of the 25 million pregnancies are associated with GDM, and this is increasing rapidly over time. Reported prevalence rates for GDM in Sri Lanka and Bangladesh are 13% and 10% respectively, although the Bangladesh estimate varied from 9.7% to 12.9% when different criteria were used.
Knowledge gap: There is knowledge gap on whether a resource- and culturally-appropriate lifestyle intervention program will be more effective and cost effective relative to usual care in delaying or preventing incidence of T2D among women in South Asia. Evidence from developed countries indicates that a low-intensity lifestyle intervention, integrated with antenatal care in the health system, optimizes healthy diet and attenuates physical activity decline in early pregnancy.
Study Design: An open-label parallel group pragmatic individual RCT with blinded primary endpoint adjudication will be performed. The RCT will be preceded by an intervention development and optimization phase.
Study Setting: This is an individual RCT in 1414 women from 24 hospitals (approx) in India (700 participants from 10-12 hospitals), Bangladesh (350 participants from 4 hospitals) and Sri Lanka (350 participants from 4 hospitals).
Sample Size: The inclusion of 1414 women with GDM from 24 hospitals (~60/hospital) will provide 90% power (2α=0.05) to detect a relative risk of ≤0.65, assuming that the control group cumulative incidence for change in glycaemic category will be at least 20% (median follow-up 24 months), and allowing for 20% drop out from trial (data) follow-up. A key secondary outcome is body weight; inclusion of 1414 women will provide 90% power to detect a difference of 1.8kg (assuming mean body weight of 64.2kg [sd 10.4]) in a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria will be the absence of T2DM (i.e. confirmation of NGT, IFG or IGT) at 3 to 18 months post-partum OGTT.
排除标准
- •Exclusion criteria will be limited to:
- •Travel time to hospital more than 2 hours (unless individual circumstances will not impede hospital attendance for study visits), lack of access to a mobile telephone, use of steroids during pregnancy (other than for lung maturation of the baby), confirmed case of Type 2 Diabetes, likelihood of moving residence in the next 3 years, refused consent .
研究组 & 干预措施
Intervention
Participants randomized in to the intervention group will receive group sessions, monthly phone calls, and telephonic prompts (text/voice recording).
干预措施: Life style Intervention (Behavioral)
Control
Control group participants will be referred to their usual doctor for ongoing management, with no attempt made to influence this. They will not get any part of the intervention but will receive the usual care (if any exists). Any abnormal OGTT results during the follow-up visits will be provided to the patient and their doctor. This is entirely consistent with current usual care.
结局指标
主要结局
Proportion of women with a change of glycaemic category, at or prior to final visit
时间窗: 3 years
From Normal Glucose Tolerance to Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or T2DM; or Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) to Type 2 Diabetes Mellitus (T2DM).
次要结局
- Changes in fasting blood glucose as assessed by OGTT(3 years)
- Change in body weight as assessed by the standard study weighing scale(3 years)
- Change in waist circumference (in cm) as assessed by the standard study measuring tape(3 years)
- Change in systolic blood pressure (SBP) as assessed by Omron BP measuring machine(3 years)
- Change in physical activity level as assessed by Modified Global Physical Activity Questionnaire (MGPAQ)(3 years)
- Change in dietary habits as assessed by Intake 24 (a 24-hour recall questionnaire)(3 years)