A Trial of One to One Weight Management in Primary Care
A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, WC1E 7HT
- London School of Hygiene and Tropical Medicine
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London, United Kingdom
- Several GP practices in the Camden and Westminster area.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Structured lifestyle support
Intervention group-structured lifestyle support.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Changes in weight, waist circumference and percent body fat at 12 months.
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Weight, waist circumference, and percent body fat at 6 months.
Time Frame: 0 and 6 months
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0 and 6 months
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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
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0 and 12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kiran Nanchahal, MSc, London School of Hygiene and Tropical Medicine
Publications and helpful links
General Publications
- Noble LM, Godfrey E, Al-Baba L, Baez G, Thorogood N, Nanchahal K. Treatment fidelity in the Camden Weight Loss (CAMWEL) intervention assessed from recordings of advisor-participant consultations. BMC Obes. 2018 Sep 10;5:24. doi: 10.1186/s40608-018-0203-7. eCollection 2018.
- McCambridge J, Sorhaindo A, Quirk A, Nanchahal K. Patient preferences and performance bias in a weight loss trial with a usual care arm. Patient Educ Couns. 2014 May;95(2):243-7. doi: 10.1016/j.pec.2014.01.003. Epub 2014 Jan 13.
- Nanchahal K, Power T, Holdsworth E, Hession M, Sorhaindo A, Griffiths U, Townsend J, Thorogood N, Haslam D, Kessel A, Ebrahim S, Kenward M, Haines A. A pragmatic randomised controlled trial in primary care of the Camden Weight Loss (CAMWEL) programme. BMJ Open. 2012 May 4;2(3):e000793. doi: 10.1136/bmjopen-2011-000793. Print 2012.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- phpepw71
- Sponsors number:PHPEPW71
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