A Trial of One to One Weight Management in Primary Care
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|ClinicalTrials.gov Identifier: NCT00891943|
Recruitment Status : Unknown
Verified April 2009 by London School of Hygiene and Tropical Medicine.
Recruitment status was: Active, not recruiting
First Posted : May 1, 2009
Last Update Posted : April 9, 2010
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight||Other: Structured lifestyle support||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
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.
- Changes in weight, waist circumference and percent body fat at 12 months. [ Time Frame: 12 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|