A Trial of One to One Weight Management in Primary Care
Primary Purpose
Obesity, Overweight
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Structured lifestyle support
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Randomised controlled trial, Primary Care, Weight, Cardiovascular Risk, Diabetes, Quality of life
Eligibility Criteria
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
Sites / Locations
- London School of Hygiene and Tropical Medicine
- Several GP practices in the Camden and Westminster area.
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Structured lifestyle support
Usual care for weight management
Arm Description
Intervention group-structured lifestyle support.
This is the control group, and they will receive "usual care" for weight management at their GP practice.
Outcomes
Primary Outcome Measures
Changes in weight, waist circumference and percent body fat at 12 months.
Secondary Outcome Measures
Weight, waist circumference, and percent body fat at 6 months.
BMI, blood pressure, resting heart rate; obesity and weight related quality of life, Rosenberg measure of self-esteem changes at 12 months.
Full Information
NCT ID
NCT00891943
First Posted
April 30, 2009
Last Updated
April 8, 2010
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
NHS Camden
1. Study Identification
Unique Protocol Identification Number
NCT00891943
Brief Title
A Trial of One to One Weight Management in Primary Care
Official Title
A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
NHS Camden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Obesity, Overweight, Randomised controlled trial, Primary Care, Weight, Cardiovascular Risk, Diabetes, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Structured lifestyle support
Arm Type
Other
Arm Description
Intervention group-structured lifestyle support.
Arm Title
Usual care for weight management
Arm Type
No Intervention
Arm Description
This is the control group, and they will receive "usual care" for weight management at their GP practice.
Intervention Type
Other
Intervention Name(s)
Structured lifestyle support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in weight, waist circumference and percent body fat at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Weight, waist circumference, and percent body fat at 6 months.
Time Frame
0 and 6 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiran Nanchahal, MSc
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
London School of Hygiene and Tropical Medicine
City
London
ZIP/Postal Code
WC1E 7HT
Country
United Kingdom
Facility Name
Several GP practices in the Camden and Westminster area.
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30214815
Citation
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.
Results Reference
derived
PubMed Identifier
24492159
Citation
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.
Results Reference
derived
PubMed Identifier
22561352
Citation
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.
Results Reference
derived
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A Trial of One to One Weight Management in Primary Care
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