Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Weight change
研究概览
简要总结
A study to determine the effectiveness of two weight loss maintenance interventions in Counterweight Plus, a structured weight management programme.
详细描述
Introduction
Long-term maintenance of non-surgical weight loss remains the most significant problem in obesity treatment. This study will compare the effectiveness of two different weight loss maintenance strategies used as part of the Counterweight Plus weight management programme. This study will also evaluate the behavioural impact of the Counterweight Plus interventions and include process evaluations and cost analysis.
Methods: 80 patients and 10 practitioners will be recruited into the study. Main inclusion criteria for patients are:
Completed Counterweight Plus, which includes 12-20 weeks total diet replacement (TDR), 8 weeks food reintroduction (FR) and achieved >10kg weight loss. All participants will be followed up for 18 months in total.
Results: The primary outcome of this study is the difference in weight change between the two groups at 6 months. Frequency of use of behavioural strategy will be quantified for both practitioners and patients during voice recorded consultations. The relationship between weight change and the use of behavioural strategy will be assessed.
Hypothesis
This study will establish if the novel intermittent use of formula diet strategy is more effective at preventing weight regain in comparison to usual care. It will also provide evidence of the frequency of use of behavioural strategies within routine Counterweight Plus delivery, as well as establishing the cost of the intervention.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Counterweight Plus Total Diet Replacement and Food Reintroduction stages and achieved >10kg weight loss
排除标准
- •People currently participating in another clinical research trial (not including BEYOND Weight Loss study)
研究组 & 干预措施
Continuous energy restriction
1 x formula food (202-209kcal) meal replacement per day
干预措施: Continuous energy restriction (Dietary Supplement)
Intermittent energy restriction
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
干预措施: Intermittent energy restriction (Dietary Supplement)
结局指标
主要结局
Weight change
时间窗: Baseline, 26 weeks
Difference between the two groups in change in body weight (kg)
次要结局
- Acceptability(Baseline, 26 weeks, 52 weeks, 78 weeks)
- Cost of interventions(78 weeks)
- Weight change(Baseline, 52 weeks, 78 weeks)
- Behavioural strategies(78 weeks)
- Eating behaviours(Baseline, 26 weeks, 52 weeks, 78 weeks)
- Quality of life(Baseline, 26 weeks, 52 weeks, 78 weeks)