Trial Outcomes & Findings for Auricular Acupuncture in the Treatment of Obesity (NCT NCT02269371)
NCT ID: NCT02269371
Last Updated: 2024-08-06
Results Overview
As assessed by weight in pounds. Weight change between baseline and week 24. Positive number equals pounds lost.
COMPLETED
NA
82 participants
baseline to week 24 (12 wks post visit 12)
2024-08-06
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
36
|
|
Overall Study
COMPLETED
|
29
|
25
|
|
Overall Study
NOT COMPLETED
|
17
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Auricular Acupuncture in the Treatment of Obesity
Baseline characteristics by cohort
| Measure |
Group 1 (Auricular Acupuncture)
n=46 Participants
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.
|
Group 2 (Sham Acupuncture)
n=36 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.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline to week 24 (12 wks post visit 12)Population: participants analyzed are those who completed the study and did not withdraw
As assessed by weight in pounds. Weight change between baseline and week 24. Positive number equals pounds lost.
Outcome measures
| Measure |
Group 1
n=25 Participants
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.
|
Group 2
n=26 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.
|
|---|---|---|
|
Weight Change
|
7 pounds
Interval 0.0 to 42.4
|
15.1 pounds
Interval 0.0 to 37.4
|
Adverse Events
Group 1
Group 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jill M. Clark, MBA/HCM
Mike O'Callaghan Federal Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place