A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 380
- Locations
- 2
- Primary Endpoint
- Changes in weight, waist circumference and percent body fat at 12 months.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years or over
- •BMI ≥ 25 kg/m2
- •GP confirmation
Exclusion Criteria
- •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
Arms & Interventions
Structured lifestyle support
Intervention group-structured lifestyle support.
Intervention: 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.
Outcomes
Primary Outcomes
Changes in weight, waist circumference and percent body fat at 12 months.
Time Frame: 12 months
Secondary Outcomes
- 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)