ObesityPhase 2NCT00069732
Study of Two Complementary and Alternative Medical Treatments for Maintenance of Weight Loss
A Phase 2 study testing qigong and acupressure-TAT in people with Obesity, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- qigong and acupressure-TAT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot of Two CAM Treatments for Maintenance of Weight Loss
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.
Read the 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
- Being tested
- qigong, acupressure-TAT
- Keywords
- Overweight, Weight loss maintenance, CAM therapy, Qigong, Acupressure, Traditional Chinese Medicine
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qigongBehavioural
acupressure-TATBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Patricia J Elmer, PhD, Principal investigator, Center for Health Research, Northwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069732
- Sponsor's protocol ID
- R21AT001190-01A1
- Other IDs
- R21AT001190-01A1
- Status last verified
- Feb 2010
- First submitted
- 30 Sep 2003
- Last updated
- 12 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Two CAM Treatments for Maintenance of Weight Loss
- ClinicalTrials.gov ID
- NCT00069732
- Acronym / sponsor ID
- R21AT001190-01A1
- Conditions
- Obesity
- Keywords
- Overweight, Weight loss maintenance, CAM therapy, Qigong, Acupressure, Traditional Chinese Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 90 participants
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- First posted
- 3 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qigong | Behavioural | – |
| acupressure-TAT | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia J Elmer, PhD principal investigator
Center for Health Research, Northwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing qigong and acupressure-TAT in people with Obesity, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2010.