An Evaluation of the Efficacy of a Group Treatment Intervention for Weight Regain After Bariatric Surgery-A Pilot Project
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Weight Regain After Bariatric Surgery
研究概览
简要总结
There are three different phases to this study:
- Screening phase to determine if you are eligible to participate in the study.
- Study phase, which will entail diet and activity, exercise and then finally self monitoring goals.
- End of treatment phase where you will be asked to complete questionnaires.
详细描述
The purpose of this study is to determine the feasibility of a group treatment program for individuals experiencing weight regain after bariatric surgery and to evaluate the effectiveness of the group treatment program. There is little information on programs to assist patients who experience weight regain after bariatric surgery. This treatment program will focus on behavioral changes and activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weight regain post-RYGB of at least 5 kg since reaching their weight nadir.
- •Male or Female age 18 -
- •Undergone RYGB 12 - 36 month prior.
- •Ability to read, write and understand English.
- •Experienced at least a 25% total weight loss since surgery.
- •BMI at least 27 kg/m.
- •Weight regain of no more than half of excess body weight. These cases will be referred back to the surgeon.
排除标准
- •Taking Weight-suppressing medication (e.g. phentermine, bupropion)
- •On medications known to cause weight gain
- •Change in smoking status with past three months
- •Change in antidepressant or other psychotropic medication or dosage in past six weeks
- •Change in psychotherapy status in past six weeks
- •Current purging behaviors occurring more than once per week over the past six weeks (vomiting or laxative/diuretic use for the purpose of weight loss
- •Current alcohol abuse or dependence or illicit drug use in past three months
- •Active bipolar or psychotic spectrum disorder
- •Current suicidality or homicidality
- •Severe neuropsychological disease (history of seizure, uncontrolled hypertension
- •Condition associated with cognitive dysfunction (e.g. Alzheimer's dementia, other neurological conditions)
- •Medically unstable condition or one which the investigators feel put the participant at risk in the study
- •Functional limitations-not able to walk 2 block without assistance
- •Exercise is contra-indicated (e.g., severe cardiovascular disease, uncontrolled hypertension, hematocrit.<30%, chronic kidney disease, severe pulmonary disease
结局指标
主要结局
Weight Regain After Bariatric Surgery
时间窗: 6 months
The overall goal of the project is to collect pilot data for a RO1 application. The primary outcome will be kg lost and BMI units lost from pre- to post-treatment. The effect size (Mean1 - Mean2 / pooled s.d.) of the intervention will be determined for within subject and between subject differences. It is hypothesized that a moderate effect size (.5) will be demonstrated and that has been selected a priori as the criteria for pursuing a larger-scale randomized clinical trial.
次要结局
- Daily caloric intake(6 months)
- Daily protein intake(6 months)
- Number of minutes of physical activity(6 months)
- Presence of disordered eating behaviors(6 months)