A Trial of One to One Weight Management in Primary Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Other: Structured lifestyle support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Structured lifestyle support<br>Intervention group-structured lifestyle support. | Other: Structured lifestyle support<br>* The intervention group will meet with a research nurse on 14 occasions over the 1 year research study, for structured lifestyle support, including dietary, physical activity and behavioral advice. They will also receive a pedometer.<br>|
| No Intervention: Usual care for weight management<br>This is the control group, and they will receive usual care for weight management at their GP practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weight, waist circumference and percent body fat at 12 months. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Randomised controlled trial, Primary Care, Weight, Cardiovascular Risk, Diabetes, Quality of life