Auricular Acupuncture in the Treatment of Obesity: a Randomized, Placebo-controlled, Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Weight Change
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
- •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
排除标准
- •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
结局指标
主要结局
Weight Change
时间窗: 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.
次要结局
未报告次要终点
研究者
Paul Crawford
Principal Investigator
Mike O'Callaghan Military Hospital