Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT00069732
Status:
TERMINATED
Last Update Posted:
2010-02-12
First Post:
2003-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Two Complementary and Alternative Medical Treatments for Maintenance of Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064906', 'term': 'Qigong'}], 'ancestors': [{'id': 'D001945', 'term': 'Breathing Exercises'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 90}}, 'statusModule': {'overallStatus': 'TERMINATED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2010-02-11', 'studyFirstSubmitDate': '2003-09-30', 'studyFirstSubmitQcDate': '2003-10-02', 'lastUpdatePostDateStruct': {'date': '2010-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-03', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Overweight', 'Weight loss maintenance', 'CAM therapy', 'Qigong', 'Acupressure', 'Traditional Chinese Medicine'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to pilot test in a group of overweight-obese individuals the feasibility and acceptability and indications of efficacy of two CAM treatments, qigong, and acupressure-TAT, for improving long term maintenance of weight loss.', 'detailedDescription': 'The prevalence of obesity is at epidemic proportions, 60% of US adults are overweight or obese. Obesity contributes to chronic diseases (diabetes, cardiovascular disease \\[CVD\\], hypertension, cancer, and osteoarthritis) and to escalating health care costs. Weight loss can have a substantial impact on reducing these conditions. Substantial efforts have been made in developing effective short-term weight loss programs using behavioral treatments. However, long-term maintenance of weight loss continues to be problematic - many individuals regain the weight lost within a year. Innovative intervention options are critically needed to help people successfully maintain weight loss and to fight the obesity epidemic. Complementary and alternative medicine (CAM) approaches-mind-body, energy healing, and Traditional Chinese Medicine (TCM) approaches may hold great promise for helping improve the maintenance of weight loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 25-35 kg/m 2\n* Reside in Portland metropolitan area\n* Willing to complete the 12-week weight loss program\n* Willing to accept random assignment to one of the three maintenance treatment conditions\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Medical conditions or treatments that would be contraindicated using a diet \\& exercise weight loss treatment\n* Cancer\n* Significant GI disease inappropriate for diet and physical activity intervention\n* Diabetes dependent on insulin or oral hypoglycemic medications\n* Psychiatric hospitalization in past 2 years\n* Conditions that require limitation of physical activity\n* Congestive Heart Failure\n* Cardiovascular Disease (stroke, MI, CABG, ASCVD)\n* Taking weight loss medications currently or within past 6 months\n* Previous history of complementary or alternative medicine (CAM) weight loss treatment\n* Current acupressure, or Qi Gong, or acupuncture\n* Reported consumption of more than 21 alcoholic drinks per week\n* Planning to leave the area prior to the end of the program\n* Body weight change \\> 10 pounds in the 6 months prior to Screening visit one\n* Pregnant, breast feeding, or planning pregnancy prior to the end of participation\n* Current participation in another clinical trial\n* Investigator discretion for safety or adherence reasons\n* Household member of another CAM WT participant\n* Unavailable for group sessions'}, 'identificationModule': {'nctId': 'NCT00069732', 'briefTitle': 'Study of Two Complementary and Alternative Medical Treatments for Maintenance of Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Pilot of Two CAM Treatments for Maintenance of Weight Loss', 'orgStudyIdInfo': {'id': 'R21AT001190-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21AT001190-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21AT001190-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21AT001190-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'qigong', 'type': 'BEHAVIORAL'}, {'name': 'acupressure-TAT', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Center for Health Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Patricia J Elmer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Health Research, Northwest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}]}}}