The Effect of Measuring Resting Metabolic Rate (RMR) in the Context of Moderate or Intensive Behavior Modification Treatment on Weight Loss
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- This study is designed to gain experience with the HealtheTech measurement system (BalanceLog) in the context of a clinical trial and to develop the related treatment protocols
研究概览
简要总结
This study is designed to gain experience with the HealtheTech measurement system (BalanceLog) in the context of a clinical trial and to develop the related treatment protocols. In this study the aim is to evaluate two interventions, one moderate and the other intensive behavioral management. The development and evaluation of a HealtheTech protocol across these two treatment settings will provide useful data about implementation (e.g., technical issues, clinical issues, participant satisfaction) and outcomes (weight loss, retention). These data can provide empirical and clinical support for practice guidelines.
详细描述
Study Duration: The duration of the study is approximately one year (51 weeks), divided into four phases: 1) Pre-study, 2) Baseline, 3) Intervention, and 4) Maintenance. Participants will be oriented to the procedures and equipment during the pre-study phase (first 3 weeks). During the baseline and intervention phases (24 weeks), participants will be undergoing weight loss treatment. Participants will maintain their weight loss during the maintenance phase (24 weeks).
Subject Recruitment and Selection : Participants will be 80 participants (BMI of 25 to 43 kg/m2) age > 21 years who have access to a personal computer (PC). The anticipated gender balance in the study group will be 80% females and 20% males. Forty participants will be recruited at the University of Pennsylvania and 40 at St. Luke's Hospital in New York City. Participants will be randomly assigned to a moderate or intensive intervention (described below).
Research Design : This study is divided into four phases:
Phase 1 (Pre-study): Screening medical and nutritional evaluation, RMR measurement, Balance Log orientation. There will be 3 weeks in which participants learn how to use the BalanceLog Pro technology, including transferring information to the clinic (i.e., at week -3 become familiar with logging and establish a Balance Log Pro account, log meals and activity and upload data to the Balance Log Pro at week -2, learn how to use special Balance Log functions such as adding foods and receive feedback via email concerning Balance Log Pro upload at week -1). In order to be randomized, participants will need to be proficient in the use of technology so that that treatment can focus on inducing weight loss rather than learning the software.
Phase 2 (Baseline): All participants will participate in weekly individual meetings with the dietitian (R.D.) for 6 weeks. This is designed to establish a solid base for the study and provide a good start on weight loss.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 25 to 43 kg/m2
- •age > 21 years
- •access to a personal computer (PC)
排除标准
- •BMI above/below 25-43 kg/m2
- •age < 21 years
- •no access to a personal computer (PC)
- •type 2 diabetes
- •participants taking medications known to affect weight, appetite or energy expenditure
结局指标
主要结局
This study is designed to gain experience with the HealtheTech measurement system (BalanceLog) in the context of a clinical trial and to develop the related treatment protocols
时间窗: 12 months
次要结局
未报告次要终点