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

Obesity Clinical Trial

Official title:

Pilot of Two CAM Treatments for Maintenance of Weight Loss

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00069732
• Other study ID #: R21AT001190-01A1
• Secondary ID: R21AT001190-01A1
• Status: Terminated
• Phase: Phase 2
• First received: September 30, 2003
• Last updated: February 11, 2010

Study information

• Verified date: February 2010
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• qigong

• acupressure-TAT

Locations

Country	Name	City	State
United States	Center for Health Research	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	National Center for Complementary and Integrative Health (NCCIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States,