ObesityAcupObesityNCT02269371
Auricular Acupuncture in the Treatment of Obesity
A study testing Auricular Acupuncture in people with Obesity, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial summary
Male and female DoD beneficiaries ages 18 years or older, who are referred for a standard of care weight loss intervention for treatment of obesity will be recruited. Subjects will be randomized into one of two groups receiving either a standard of care weight loss intervention plus auricular acupuncture at Shen Men… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Auricular Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female DoD beneficiaries, aged 18 years or older, with a Body Mass Index of 30 or greater who were referred to a standard of care weight loss intervention
Who cannot join
- Pregnant women Patients who are taking weight loss medication Uncontrolled hypothyroidism Absence of their ear Active cellulitis of their ear Ear anatomy precluding identification of acupuncture landmarks and use of hearing aids that preclude the insertion of needles
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Las Vegas, Nevada, 89191
About this study
Official title: Auricular Acupuncture in the Treatment of Obesity: a Randomized, Placebo-controlled, Trial
Male and female DoD beneficiaries ages 18 years or older, who are referred for a standard of care weight loss intervention for treatment of obesity will be recruited. Subjects will be randomized into one of two groups receiving either a standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point or receiving a standard of care weight loss intervention plus sham auricular acupuncture. Subjects will receive treatment in accordance with their randomization group for 12 weeks then have one additional follow up visit at week 24. The following measures will be obtained: height, weight, waist circumference, and Body Mass Index will be calculated.
Read the detailed description
Screening Visit:
Obtain signed Informed Consent document and HIPAA Authorization. Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria and to verify the inclusion/exclusion criteria including previous encounter, vital signs review, medication list, co-morbidities, demographics, problems list, and note any prior acupuncture received.
Record: Date of birth, age, gender, race, ethnicity, last 4 of social security number, name of standard of care weight loss intervention, current email address, height (in inches), weight (in pounds), waist circumference (in inches) measurement, previous bariatric surgery, and body mass index calculated.
Visit 1-Week 1: (1st week of standard of care weight intervention)
Subjects will be randomized into 1 of 2 groups and treated:
- Group 1: Standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point in each ear. The 3 needles will remain in each ear for 15 minutes.
- Group 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. The 3 needles will remain in each ear for 15 minutes.
All subjects, regardless of randomization group, will be instructed to have no heavy meals, no excessive hot or cold foods, no heavy exercise or intercourse, and no alcohol for 24 hours after this visit.
Visit 2-12 (Week 2-12 of standard of care weight intervention):
Subjects will be given treatment according to their randomization group. The acupuncture needles will be applied and remain in each ear for 15 minutes.
Record: weight, waist circumference measurement, and document compliance for standard of care weight loss intervention (i.e. attendance and measurements from class).
All subjects, regardless of randomization group, will be instructed to have no heavy meals, no excessive hot or cold foods, no heavy exercise or intercourse, and no alcohol for 24 hours after this visit.
Visit 13 (Week 24/12 weeks post visit 12):
Record: weight, and waist circumference measurement.
Subjects will be asked the following questions:
- Do you follow a regular routine of physical exercise? Yes/No *If yes, what type of exercise (mark all that apply):
- Aerobic (cardiovascular endurance, e.g. cycling, swimming, walking, hiking)
- Anaerobic (strength or resistance, e.g. weight lifting, sprinting, interval training)
- Flexibility (stretching, e.g. yoga, pilates, gymnastics) On average, how many times per week do you exercise?
- 0-1
- 2-4
- 5+ How many minutes on average is each exercise session?
- 10-20
- 20-30
- 30-60
- 60 At what level of intensity?
- Light
- Moderate
- Heavy How would you rate the "health" of your eating habits?
- Poor
- Fair
- Average
- Good
- Excellent
- Conditions
- Obesity
- Being tested
- Auricular Acupuncture, Sham Acupuncture
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupunctureOther
Also called acupuncture
Standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point in each ear.
Sham AcupunctureOther
Also called sham
Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1: Standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point in each ear. Receives: Other: Auricular Acupuncture |
| Group 2 | Sham comparator | Group 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. Receives: Other: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
As assessed by weight in pounds. Weight change between baseline and week 24. Positive number equals pounds lost.
Measured: baseline to week 24 (12 wks post visit 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Crawford, Mike O'Callaghan Military Hospital
- Investigators
- Clinton Borchardt, MD, Principal investigator, Mike O'Callaghan Federal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269371
- Sponsor's protocol ID
- FWH20140089H
- Acronym
- AcupObesity
- Status last verified
- Jun 2024
- First submitted
- 14 Oct 2014
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture in the Treatment of Obesity: a Randomized, Placebo-controlled, Trial
- ClinicalTrials.gov ID
- NCT02269371
- Acronym / sponsor ID
- AcupObesity / FWH20140089H
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Male and female DoD beneficiaries ages 18 years or older, who are referred for a standard of care weight loss intervention for treatment of obesity will be recruited. Subjects will be randomized into one of two groups receiving either a standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point or receiving a standard of care weight loss intervention plus sham auricular acupuncture. Subjects will receive treatment in accordance with their randomization group for 12 weeks then have one additional follow up visit at week 24. The following measures will be obtained: height, weight, waist circumference, and Body Mass Index will be calculated.
Detailed description
Screening Visit:
Obtain signed Informed Consent document and HIPAA Authorization. Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria and to verify the inclusion/exclusion criteria including previous encounter, vital signs review, medication list, co-morbidities, demographics, problems list, and note any prior acupuncture received.
Record: Date of birth, age, gender, race, ethnicity, last 4 of social security number, name of standard of care weight loss intervention, current email address, height (in inches), weight (in pounds), waist circumference (in inches) measurement, previous bariatric surgery, and body mass index calculated.
Visit 1-Week 1: (1st week of standard of care weight intervention)
Subjects will be randomized into 1 of 2 groups and treated:
- Group 1: Standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point in each ear. The 3 needles will remain in each ear for 15 minutes.
- Group 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. The 3 needles will remain in each ear for 15 minutes.
All subjects, regardless of randomization group, will be instructed to have no heavy meals, no excessive hot or cold foods, no heavy exercise or intercourse, and no alcohol for 24 hours after this visit.
Visit 2-12 (Week 2-12 of standard of care weight intervention):
Subjects will be given treatment according to their randomization group. The acupuncture needles will be applied and remain in each ear for 15 minutes.
Record: weight, waist circumference measurement, and document compliance for standard of care weight loss intervention (i.e. attendance and measurements from class).
All subjects, regardless of randomization group, will be instructed to have no heavy meals, no excessive hot or cold foods, no heavy exercise or intercourse, and no alcohol for 24 hours after this visit.
Visit 13 (Week 24/12 weeks post visit 12):
Record: weight, and waist circumference measurement.
Subjects will be asked the following questions:
- Do you follow a regular routine of physical exercise? Yes/No *If yes, what type of exercise (mark all that apply):
- Aerobic (cardiovascular endurance, e.g. cycling, swimming, walking, hiking)
- Anaerobic (strength or resistance, e.g. weight lifting, sprinting, interval training)
- Flexibility (stretching, e.g. yoga, pilates, gymnastics) On average, how many times per week do you exercise?
- 0-1
- 2-4
- 5+ How many minutes on average is each exercise session?
- 10-20
- 20-30
- 30-60
- 60 At what level of intensity?
- Light
- Moderate
- Heavy How would you rate the "health" of your eating habits?
- Poor
- Fair
- Average
- Good
- Excellent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Auricular AcupunctureGroup 1: Standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point in each ear. |
| Group 2 | Sham comparator | Other: Sham AcupunctureGroup 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female DoD beneficiaries, aged 18 years or older, with a Body Mass Index of 30 or greater who were referred to a standard of care weight loss intervention
Key exclusion criteria (1 listed)
- Pregnant women Patients who are taking weight loss medication Uncontrolled hypothyroidism Absence of their ear Active cellulitis of their ear Ear anatomy precluding identification of acupuncture landmarks and use of hearing aids that preclude the insertion of needles
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 |
|---|---|---|
| Auricular AcupunctureAlso: acupunctureStandard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point in each ear. | Other | Group 1 |
| Sham AcupunctureAlso: shamStandard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. | Other | Group 2 |
Primary outcome
Weight Change
Time frame: baseline to week 24 (12 wks post visit 12)
As assessed by weight in pounds. Weight change between baseline and week 24. Positive number equals pounds lost.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Clinton Borchardt, MD principal investigator
Mike O'Callaghan Federal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupuncture in people with Obesity, run by Mike O'Callaghan Military Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Aug 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Weight Change (time frame: baseline to week 24 (12 wks post visit 12)). It is what the study was designed to measure, not a finding.
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 6 Aug 2024.