A Trial of One to One Weight Management in Primary Care

NCT ID: NCT00891943

Last Updated: 2010-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Structured lifestyle support

Intervention group-structured lifestyle support.

Group Type OTHER

Structured lifestyle support

Intervention Type OTHER

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.

Usual care for weight management

This is the control group, and they will receive "usual care" for weight management at their GP practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Camden

OTHER_GOV

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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London School of Hygiene and Tropical Medicine

Principal Investigators

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Kiran Nanchahal, MSc

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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London School of Hygiene and Tropical Medicine

London, , United Kingdom

Site Status

Several GP practices in the Camden and Westminster area.

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 30214815 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24492159 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22561352 (View on PubMed)

Other Identifiers

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Sponsors number:PHPEPW71

Identifier Type: -

Identifier Source: secondary_id

phpepw71

Identifier Type: -

Identifier Source: org_study_id

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