Randomized Trial of Tapas Acupressure for Weight Loss Maintenance
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 472
- 主要终点
- weight
研究概览
简要总结
This randomized clinical trial evaluates the efficacy of TAT(Tapas Acupressure Technique) compared to a Social Support (SS) group for the primary outcome of weight loss maintenance. We recruit obese adults from the Kaiser Permanente Northwest managed care setting. Those who meet eligibility criteria are entered into an intensive six-month weekly group-based behavioral weight loss program. Those who meet threshold weight loss criteria (n=~288) are randomly assigned to either TAT instruction or social support group. Participants in both groups attend the same schedule of group meetings with parallel contact hours. Participants in the TAT group are advised to practice the technique at home. Participants are weighed and questionnaires administered at entry, randomization, and at 12 and 18 months post entry. The main outcome measure is weight at 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for the Phase I weight loss program:
- •Men and women
- •At least 30 years of age
- •BMI 30-50 kg/m2 (inclusive)
- •Weight <400 lbs
- •Reside in Portland metropolitan area including Vancouver/Clark County, Washington
- •Willing and able to participate in all aspects of the intervention
- •Willing to attend the group-based weight loss program for 6 months
- •Willing to follow a reduced calorie healthy dietary pattern
- •Willing to exercise on a regular basis
- •Willing to lose 10 pounds during the 6-month weight loss program
- •Willing to accept random assignment to one of the two maintenance interventions
- •Willing to provide informed consent
排除标准
- •for the Phase I weight loss program
- •Medical conditions or treatments that would be contraindicated using a diet and exercise weight loss treatment
- •Treatment for cancer (except for non-melanoma skin cancer) currently or in the past 2 years
- •Diabetes treated with insulin; does not exclude diet-controlled, controlled with sulfonylurea (glyburide, glipizide, etc.) with primary physician's approval, or controlled with other oral agents (metformin, precose, glitazone.)
- •Psychiatric hospitalization in past 2 years
- •Conditions that require limitation of physical activity
- •Congestive heart failure
- •Cardiovascular disease (stroke, MI, CABG, angioplasty/stent) in the past 2 years
- •Taking weight loss medications currently or within past 6 months
- •Any history of weight loss surgery or scheduled surgery for weight loss.
- •Liposuction in the past 12 months
- •Prior acupuncture or acupressure treatments for weight loss
- •Planning to leave the area prior to the end of the program
- •Body weight change > 20 pounds in the past 6 months
- •Pregnant, breast feeding, or planning pregnancy prior to the end of participation
- •Current participation in another clinical trial
- •Investigator discretion for safety or adherence reasons
- •Household member (living at the same address) of another participant in this study
- •LIFE clinical trial staff member or family member of LIFE trial staff person
研究组 & 干预措施
1
TAT (Tapas Acupressure Technique)
干预措施: Tapas Acupressure Technique (Behavioral)
2
SS (Professionally facilitated social support groups)
干预措施: Social support (Behavioral)
结局指标
主要结局
weight
时间窗: 18 months
次要结局
- psychosocial measures, exercise, food frequency, and food cravings variables(randomization, and @ months 12 and 18)