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
- 2
- 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
研究组 & 干预措施
Structured lifestyle support
Intervention group-structured lifestyle support.
干预措施: Structured lifestyle support (Other)
Usual care for weight management
This is the control group, and they will receive "usual care" for weight management at their GP practice.
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)