Auricular Acupuncture in the Treatment of Obesity

NCT02269371 | Completed Results

• 1 other identifier: FWH20140089H
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Weight Change

  As assessed by weight in pounds. Weight change between baseline and week 24. Positive number equals pounds lost.

  baseline to week 24 (12 wks post visit 12)

Study Arms (2)

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.

Other: Auricular Acupuncture

Group 2

SHAM COMPARATOR

Group 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear.

Other: Sham Acupuncture

Interventions

Auricular Acupuncture OTHER

Standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point in each ear.

Also known as: acupuncture

Group 1

Sham Acupuncture OTHER

Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear.

Also known as: sham

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Las Vegas, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Acupuncture, Ear; Acupuncture Therapy; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Auriculotherapy

Results Point of Contact

• Title: Jill M. Clark, MBA/HCM
• Organization: Mike O'Callaghan Federal Medical Center

jill.clark.3.ctr@us.af.mil

7026533298

Study Officials

• Clinton Borchardt, MD

  Mike O'Callaghan Federal Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 21, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)