HealtheTech Lifestyle Program
| Tracking Information | |||||
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| First Received Date ICMJE | September 2, 2005 | ||||
| Last Updated Date | May 14, 2012 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
HealtheLifestyle participants will have greater weight loss | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00146510 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
HealtheLifestyle Program will increase efficacy of products | ||||
| 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 | HealtheTech Lifestyle Program | ||||
| Official Title ICMJE | HealtheLifestyle Behavioral Intervention Clinical Trial | ||||
| Brief Summary | The purpose of the study is to determine the efficacy of resting metabolic rate (RMR) using BodyGem and BalanceLog in helping overweight and obese individuals manage their weight. |
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| Detailed Description | The study plans are to develop and test the efficacy of a practical, structured, and time-limited behavioral intervention (HealtheLifestyle Program) as a supplement to standard HealtheTech products. Approximately 130 participants will be recruited and randomized to either the HealtheTech Program (focusing on calorie and exercise goals using the BalanceLog for tracking), the HealtheLifestyle Program (using step counters, monthly email letters and calls providing information on activity, nutrition, and weight loss), or a delayed treatment program (after 3 months undergo the intervention above). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| 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 | ||||
| Enrollment ICMJE | 130 | ||||
| Completion Date | February 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: healthy adult men and women, 18-60 years - Exclusion Criteria: not currently participating in a structured diet or exercise program - |
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00146510 | ||||
| Other Study ID Numbers ICMJE | CI-0126 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | The Cooper Institute | ||||
| Collaborators ICMJE | HealtheTech | ||||
| Investigators ICMJE |
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| Information Provided By | The Cooper Institute | ||||
| Verification Date | May 2012 | ||||
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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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