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Clinical Trials/NCT00891943
NCT00891943
Unknown
N/A

A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care

London School of Hygiene and Tropical Medicine2 sites in 1 country380 target enrollmentJune 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
London School of Hygiene and Tropical Medicine
Enrollment
380
Locations
2
Primary Endpoint
Changes in weight, waist circumference and percent body fat at 12 months.
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
December 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

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

Time Frame: 12 months

Secondary Outcomes

  • 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 Sites (2)

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