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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.
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:
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Group 2 | Sham Comparator | Group 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Clinton Borchardt, MD | Mike O'Callaghan Federal Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Federal Hospital/Nellis Air Force Base | Las Vegas | Nevada | 89191 | United States |
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Male and female Department of Defense beneficiaries ages 18 years or older were recruited at the Mike O'Callaghan Federal Medical Center. No special populations were recruited. The recruitment began April 2015 and ended February 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Group 2 | Group 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. Sham Acupuncture: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Auricular Acupuncture) | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Change | As assessed by weight in pounds. Weight change between baseline and week 24. Positive number equals pounds lost. | participants analyzed are those who completed the study and did not withdraw | Posted | Mean | Full Range | pounds | baseline to week 24 (12 wks post visit 12) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill M. Clark, MBA/HCM | Mike O'Callaghan Federal Medical Center | 7026533298 | jill.clark.3.ctr@us.af.mil |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| D015670 | Acupuncture Therapy |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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|
| Sham Acupuncture | Other | Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. |
|
|
| BG001 |
| Group 2 (Sham Acupuncture) |
Group 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. Sham Acupuncture: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Group 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear.
Sham Acupuncture: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear.
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Group 2 | Group 2: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. Sham Acupuncture: Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear. | 0 | 36 | 0 | 36 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |