Study of Two Complementary and Alternative Medical Treatments for Maintenance of Weight Loss

NCT ID: NCT00069732

Last Updated: 2010-02-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Detailed Description

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

qigong

Intervention Type: BEHAVIORAL

acupressure-TAT

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI 25-35 kg/m 2
• Reside in Portland metropolitan area
• Willing to complete the 12-week weight loss program
• Willing to accept random assignment to one of the three maintenance treatment conditions
• Willing to provide informed consent

Exclusion Criteria

• Medical conditions or treatments that would be contraindicated using a diet & exercise weight loss treatment
• Cancer
• Significant GI disease inappropriate for diet and physical activity intervention
• Diabetes dependent on insulin or oral hypoglycemic medications
• Psychiatric hospitalization in past 2 years
• Conditions that require limitation of physical activity
• Congestive Heart Failure
• Cardiovascular Disease (stroke, MI, CABG, ASCVD)
• Taking weight loss medications currently or within past 6 months
• Previous history of complementary or alternative medicine (CAM) weight loss treatment
• Current acupressure, or Qi Gong, or acupuncture
• Reported consumption of more than 21 alcoholic drinks per week
• Planning to leave the area prior to the end of the program
• Body weight change > 10 pounds in the 6 months prior to Screening visit one
• Pregnant, breast feeding, or planning pregnancy prior to the end of participation
• Current participation in another clinical trial
• Investigator discretion for safety or adherence reasons
• Household member of another CAM WT participant
• Unavailable for group sessions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Principal Investigators

Patricia J Elmer, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Health Research, Northwest

Locations

Center for Health Research

Portland, Oregon, United States

Countries

United States

Other Identifiers

R21AT001190-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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R21AT001190-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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