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Auricular Acupuncture in the Treatment of Obesity (AcupObesity)

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ClinicalTrials.gov Identifier: NCT02269371
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
JillClark, Mike O'Callaghan Military Hospital

Brief 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, 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.

Condition or disease Intervention/treatment Phase
Obesity Other: Auricular Acupuncture Other: Sham Acupuncture Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Auricular Acupuncture in the Treatment of Obesity: a Randomized, Placebo-controlled, Trial
Study Start Date : February 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
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.
Other: Auricular Acupuncture
Standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point in each ear.
Other Name: acupuncture

Sham Comparator: Group 2
Group 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear.
Other: Sham Acupuncture
Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear.
Other Name: sham




Primary Outcome Measures :
  1. greater weight loss [ Time Frame: 22 weeks ]
    As assessed by weight, waist circumference, and body mass index calculations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

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

Exclusion:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269371


Locations
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United States, Nevada
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Las Vegas, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
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Principal Investigator: Clinton Borchardt, MD Mike O'Callaghan Federal Medical Center

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Responsible Party: JillClark, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT02269371     History of Changes
Other Study ID Numbers: FWH20140089H
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms