Overview

This trial is active, not recruiting.

Conditions obesity, overweight
Treatment structured lifestyle support
Sponsor London School of Hygiene and Tropical Medicine
Collaborator NHS Camden
Start date June 2009
End date December 2010
Trial size 380 participants
Trial identifier NCT00891943, Sponsors number:PHPEPW71, phpepw71

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Other)
Intervention group-structured lifestyle support.
structured lifestyle support
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.
(No Intervention)
This is the control group, and they will receive "usual care" for weight management at their GP practice.

Primary Outcomes

Measure
Changes in weight, waist circumference and percent body fat at 12 months.
time frame: 12 months

Secondary Outcomes

Measure
Weight, waist circumference, and percent body fat at 6 months.
time frame: 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.
time frame: 0 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care
Principal investigator Kiran Nanchahal, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2010.
Information provided to ClinicalTrials.gov by London School of Hygiene and Tropical Medicine.