The Heat Study: A 2-year Lifestyle Intervention in Overweight Women to Determine Optimal Approaches for Successful Maintenance of Weight Loss
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
The purpose of this trial is to determine the most cost effective programme for overweight and obese individuals to maintain weight loss over a 2 year period.
详细描述
Although short term weight loss is often achievable in overweight individuals, long term maintenance is generally poor. The researchers urgently need new information regarding the most cost effective programme(s) for maintenance of weight loss. This study will recruit 200 women and compare two approaches for providing support: one with intensive health professional support, the other peer group support facilitated by a research nurse with frequent 'weigh- ins'. The researchers will also compare two different diets one a high carbohydrate, high fibre, low glycaemic index diet versus one relatively high in monounsaturated fat and protein and low in glycaemic load.
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
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants
- •Aged 25 to 70
- •Those who have intentionally lost more than or equal to 5% of initial body weight in the previous 6 months will be recruited
- •Objective evidence that volunteers were overweight or obese and have lost weight will be obtained from doctors records
排除标准
- •Presence of major illness including cancers
- •Established cardiovascular disease or stroke
- •Gestational diabetes
- •Renal disease
- •Malabsorption disorders
- •Thyroid disorders
- •Major psychiatric disorders
- •Taking weight loss medication or medications known to cause weight gain
- •Planning a pregnancy in the next 2 years
- •Those who do not intend to be in the area for the next 2 years
结局指标
主要结局
Weight
时间窗: 2 years
次要结局
- Body composition(2 years)
- Waist circumference and blood pressure(2 years)
- Lipid profile and glucose and insulin(2 years)
- Dietary intake(2 years)
- Physical fitness(2 years)
- Change in mood state(2 years)
研究者
Rachael Taylor
PhD student
University of Otago