Clinical trial NCT00891943: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Overweight
Keywords: Obesity
Overweight
Randomised controlled trial
Primary Care
Weight
Cardiovascular Risk
Diabetes
Quality of life
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: NHS Camden
First posted: 2009-05-01
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in weight, waist circumference and percent body fat at 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Weight, waist circumference, and percent body fat at 6 months.
timeFrame: 0 and 6 months
measure: BMI, blood pressure, resting heart rate; obesity and weight related quality of life, Rosenberg measure of self-esteem changes at 12 months.
timeFrame: 0 and 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London School of Hygiene and Tropical Medicine
city: London
country: United Kingdom
facility: Several GP practices in the Camden and Westminster area.
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Kiran Nanchahal, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.