A Trial of One to One Weight Management in Primary Care
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Obesity Overweight |
Other: Structured lifestyle support |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care |
- Changes in weight, waist circumference and percent body fat at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 380 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| 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 | |
| Principal Investigator: | Kiran Nanchahal, MSc | London School of Hygiene and Tropical Medicine |
More Information
Additional Information:
No publications provided
| 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 |
| Study First Received: | April 30, 2009 |
| Last Updated: | April 8, 2010 |
| Health Authority: | England: NHS Camden |
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:
|
Obesity Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013