A Trial of One to One Weight Management in Primary Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
NHS Camden
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00891943
First received: April 30, 2009
Last updated: April 8, 2010
Last verified: April 2009

April 30, 2009
April 8, 2010
June 2009
December 2010   (final data collection date for primary outcome measure)
Changes in weight, waist circumference and percent body fat at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00891943 on ClinicalTrials.gov Archive Site
  • Weight, waist circumference, and percent body fat at 6 months. [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial of One to One Weight Management in Primary Care
A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Overweight
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.
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
380
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00891943
phpepw71, Sponsors number:PHPEPW71
No
Ms Kiran Nanchahal, London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
NHS Camden
Principal Investigator: Kiran Nanchahal, MSc London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
April 2009

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