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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:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Obesity Overweight Other: Structured lifestyle support

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care
Study Start Date : June 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Structured lifestyle support
Intervention group-structured lifestyle support.
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.
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.


Outcome Measures

Primary Outcome Measures :
  1. Changes in weight, waist circumference and percent body fat at 12 months. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Weight, waist circumference, and percent body fat at 6 months. [ Time Frame: 0 and 6 months ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891943


Locations
United Kingdom
London School of Hygiene and Tropical Medicine
London, United Kingdom, WC1E 7HT
Several GP practices in the Camden and Westminster area.
London, United Kingdom
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
NHS Camden
Investigators
Principal Investigator: Kiran Nanchahal, MSc London School of Hygiene and Tropical Medicine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ms Kiran Nanchahal, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00891943     History of Changes
Other Study ID Numbers: phpepw71
Sponsors number:PHPEPW71
First Posted: May 1, 2009    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: April 2009

Keywords provided by London School of Hygiene and Tropical Medicine:
Obesity
Overweight
Randomised controlled trial
Primary Care
Weight
Cardiovascular Risk
Diabetes
Quality of life

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms