A Trial of One to One Weight Management in Primary Care
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 30, 2009 | ||||
| Last Updated Date | April 8, 2010 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in weight, waist circumference and percent body fat at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00891943 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Trial of One to One Weight Management in Primary Care | ||||
| Official Title ICMJE | A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 380 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00891943 | ||||
| Other Study ID Numbers ICMJE | phpepw71, Sponsors number:PHPEPW71 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ms Kiran Nanchahal, London School of Hygiene and Tropical Medicine | ||||
| Study Sponsor ICMJE | London School of Hygiene and Tropical Medicine | ||||
| Collaborators ICMJE | NHS Camden | ||||
| Investigators ICMJE |
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| Information Provided By | London School of Hygiene and Tropical Medicine | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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