NCT00891943

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 9, 2010

Status Verified

April 1, 2009

Enrollment Period

1.5 years

First QC Date

April 30, 2009

Last Update Submit

April 8, 2010

Conditions

ObesityOverweight

Keywords

ObesityOverweightRandomised controlled trialPrimary CareWeightCardiovascular RiskDiabetesQuality of life

Outcome Measures

Primary Outcomes (1)

  • Changes in weight, waist circumference and percent body fat at 12 months.

    12 months

Secondary Outcomes (2)

  • Weight, waist circumference, and percent body fat at 6 months.

    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.

    0 and 12 months

Study Arms (2)

Structured lifestyle support

OTHER

Intervention group-structured lifestyle support.

Other: Structured lifestyle support

Usual care for weight management

NO INTERVENTION

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

Interventions

Structured lifestyle supportOTHER

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.

Structured lifestyle support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or over
  • BMI ≥ 25 kg/m2
  • GP confirmation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

Several GP practices in the Camden and Westminster area.

London, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 30214815DERIVED

  • 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.

    PMID: 24492159DERIVED

  • 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.

    PMID: 22561352DERIVED

MeSH Terms

Conditions

ObesityOverweightBody WeightDiabetes Mellitus

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Kiran Nanchahal, MSc

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 9, 2010

Record last verified: 2009-04

Locations

GB(2)