Clinical trial NCT00069732: Study of Two Complementary and Alternative Medical Treatments for Maintenance of Weight Loss
Official title: Pilot of Two CAM Treatments for Maintenance of Weight Loss
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Keywords: Overweight
Weight loss maintenance
CAM therapy
Qigong
Acupressure
Traditional Chinese Medicine
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2003-10-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Center for Health Research
state: Oregon
Study officials:
affiliation: Center for Health Research, Northwest
name: Patricia J Elmer, PhD
role: PRINCIPAL_INVESTIGATOR
References: