A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care
试验速览
- 阶段
- 不适用
- 入组人数
- 380
- 试验地点
- 3
- 主要终点
- Changes in weight, waist circumference and percent body fat at 12 months.
研究概览
简要总结
The purpose of this study is to conduct a randomised controlled trial to assess the sustained effects on weight, selected risk factors and sense of well-being of offering individualized weight management advice in the primary care setting to patients who wish to lose weight; and to identify the key factors influencing the success of the intervention.
详细描述
Primary care could make a substantial impact on the increasing prevalence of overweight and obesity and their associated adverse impact on health. The lack of a proven intervention may deter health professionals in primary care from providing support to their overweight patients as few obese people recall receiving weight control advice from a health professional.
In this study we aim to conduct a large scale randomised controlled trial to assess the effectiveness of a longer-term structured lifestyle support programme provided by a research nurse and the provision of pedometers compared to usual care in overweight/ obese adults who wish to lose weight. We will assess the degree of weight loss over a period of 12 months as well as related factors such as changes in waist circumference, quality of life and cost-effectiveness of the interventions.
The research is highly relevant to policy making at both national and local levels.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or over
- •BMI ≥ 25 kg/m2
- •GP confirmation
排除标准
- •pregnant or lactating women
- •patients with renal failure, pacemakers or cancer
- •participating in other research affecting weight
- •Ability to complete questionnaires
- •Ability to give consent
结局指标
主要结局
Changes in weight, waist circumference and percent body fat at 12 months.
时间窗: 12 months
次要结局
- Weight, waist circumference, and percent body fat at 6 months.(0 and 6 months)
- BMI, blood pressure, resting heart rate; obesity and weight related quality of life, Rosenberg measure of self-esteem changes at 12 months.(0 and 12 months)