A Trial of One to One Weight Management in Primary Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care|
- Changes in weight, waist circumference and percent body fat at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Weight, waist circumference, and percent body fat at 6 months. [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Structured lifestyle support
Intervention group-structured lifestyle support.
Other: 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: Usual care for weight management
This is the control group, and they will receive "usual care" for weight management at their GP practice.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891943
|London School of Hygiene and Tropical Medicine|
|London, United Kingdom, WC1E 7HT|
|Several GP practices in the Camden and Westminster area.|
|London, United Kingdom|
|Principal Investigator:||Kiran Nanchahal, MSc||London School of Hygiene and Tropical Medicine|