A Trial of One to One Weight Management in Primary Care

Not Applicable

• Conditions: Overweight; Obesity
• Interventions: Other: Structured lifestyle support

• Registration Number: NCT00891943
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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 Timeline

• Status Verified: 2009-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Study Start: 2009-06
• Last Update Submitted: 2010-04-08
• Last Update Posted: 2010-04-09
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured lifestyle support	Structured lifestyle support	Intervention group-structured lifestyle support.

Primary Outcome Measures

Name	Time	Method
Changes in weight, waist circumference and percent body fat at 12 months.	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Several GP practices in the Camden and Westminster area.; 🇬🇧 London, United Kingdom

London School of Hygiene and Tropical Medicine; 🇬🇧 London, United Kingdom