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A Trial of One to One Weight Management in Primary Care

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ClinicalTrials.gov Identifier: NCT00891943
Recruitment Status : Unknown
Verified April 2009 by London School of Hygiene and Tropical Medicine.
Recruitment status was:  Active, not recruiting
First Posted : May 1, 2009
Last Update Posted : April 9, 2010
Sponsor:
Collaborator:
NHS Camden
Information provided by:
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE May 1, 2009
Last Update Posted Date April 9, 2010
Study Start Date  ICMJE June 2009
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
Changes in weight, waist circumference and percent body fat at 12 months. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00891943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
  • Weight, waist circumference, and percent body fat at 6 months. [ Time Frame: 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. [ Time Frame: 0 and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of One to One Weight Management in Primary Care
Official Title  ICMJE A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE Other: 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.
Study Arms  ICMJE
  • Structured lifestyle support
    Intervention group-structured lifestyle support.
    Intervention: Other: Structured lifestyle support
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 30, 2009)
380
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00891943
Other Study ID Numbers  ICMJE phpepw71
Sponsors number:PHPEPW71
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ms Kiran Nanchahal, London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE NHS Camden
Investigators  ICMJE
Principal Investigator: Kiran Nanchahal, MSc London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP