A Trial of One to One Weight Management in Primary Care

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00891943
• Other study ID #: phpepw71
• Secondary ID: Sponsors number:
• Status: Active, not recruiting
• Phase: N/A
• First received: April 30, 2009
• Last updated: April 8, 2010
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2009
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: England: NHS Camden
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 380
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	London School of Hygiene and Tropical Medicine	London
United Kingdom	Several GP practices in the Camden and Westminster area.	London

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	NHS Camden

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weight, waist circumference and percent body fat at 12 months.		12 months	No
Secondary	Weight, waist circumference, and percent body fat at 6 months.		0 and 6 months	No
Secondary	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	No

External Links

•   CAMWEL weight loss trial website