Randomized Trial of Tapas Acupressure for Weight Loss Maintenance (LIFE)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 6, 2007 | ||||
| Last Updated Date | October 4, 2011 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
weight [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
weight [ Time Frame: 18 months ] | ||||
| Change History | Complete list of historical versions of study NCT00526565 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
psychosocial measures, exercise, food frequency, and food cravings variables [ Time Frame: randomization, and @ months 12 and 18 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Trial of Tapas Acupressure for Weight Loss Maintenance | ||||
| Official Title ICMJE | Randomized Trial of Tapas Acupressure for Weight Loss Maintenance | ||||
| Brief Summary | This randomized clinical trial evaluates the efficacy of TAT(Tapas Acupressure Technique) compared to a Social Support (SS) group for the primary outcome of weight loss maintenance. We recruit obese adults from the Kaiser Permanente Northwest managed care setting. Those who meet eligibility criteria are entered into an intensive six-month weekly group-based behavioral weight loss program. Those who meet threshold weight loss criteria (n=~288) are randomly assigned to either TAT instruction or social support group. Participants in both groups attend the same schedule of group meetings with parallel contact hours. Participants in the TAT group are advised to practice the technique at home. Participants are weighed and questionnaires administered at entry, randomization, and at 12 and 18 months post entry. The main outcome measure is weight at 18 months. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Elder CR, Gullion CM, Debar LL, Funk KL, Lindberg NM, Ritenbaugh C, Meltesen G, Gallison C, Stevens VJ. Randomized trial of Tapas Acupressure Technique for weight loss maintenance. BMC Complement Altern Med. 2012 Mar 15;12:19. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 472 | ||||
| Completion Date | February 2011 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Exclusion criteria for the Phase I weight loss program
|
||||
| Gender | Both | ||||
| Ages | 30 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00526565 | ||||
| Other Study ID Numbers ICMJE | R01 AT003928-01A1, R01AT003928-01A1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kaiser Permanente | ||||
| Study Sponsor ICMJE | Kaiser Permanente | ||||
| Collaborators ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Kaiser Permanente | ||||
| Verification Date | October 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||