Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 2
- 主要终点
- weight change
研究概览
简要总结
The prevalence of obesity in young adults has been increasing, and excessive body weight have been linked to numerous chronic conditions including cardiovascular disease, diabetes, many forms of cancer, and numerous musculoskeletal problems. This study will focus of the development and evaluation of interventions that may be appropriate for young adults (age 18-35 years) to improve weight loss outcomes following a 24 month intervention. The primary aim of this study is to examine whether an enhanced weight loss intervention (EWLI) that includes technology components results in improved weight loss in young adults (18-35 years of age) compared to a standard behavioral weight loss intervention (SBWP) over a period of 24 months. Eligible participants will also be assessed for body composition, body fat distribution, fitness, physical activity, dietary intake, and behavioral/psychosocial measures that may be predictive of behavior change. Assessments will occur at 0, 6, 12, 18, and 24 months. Subjects will participate in a 24 month behavioral weight loss program that includes a reduction in energy intake and moderate-to-vigorous intensity exercise (progressively increasing from 100 to 300 minutes per week). The technologies added to EWLI are text messaging, a wearable device that provides feedback on physical activity, and access to a website to monitor dietary behaviors.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-35 years of age
- •Intending to be available for a 24 month intervention
- •An active cellular telephone that is capable of receiving text messaging
- •A computer and internet connectivity that can be used for the BodyMedia Fit system
- •Body mass index (BMI) between 25.0-39.9 kg/m2
- •The ability to provide medical clearance to participate in this study from their primary care physician
- •The ability to complete the baseline graded exercise test, and clearance from the study physician to participate in this study after reviewing the results from this study
排除标准
- •Unable to provide informed consent
- •Household member on study staff
- •Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); current or planned enrollment in another diet/PA/weight loss intervention study
- •Report regular use of systemic steroids, prescription weight loss drugs. "Regular use" is defined as "taking this medication most days of the week for the previous month"
- •Current treatment for eating disorder
- •Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
- •Current treatment for malignancy (other than non-melanoma skin cancer)
- •Currently pregnant or gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, actively planning pregnancy within the next 24 months
- •Investigator discretion
- •Currently taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers)
- •Report losing >5% of current body weight in the previous 6 months
- •Currently treated for psychological issues, or taking psychotropic medications within the previous 6 months
- •Report taking medication that could affect metabolism or change body weight
- •Current treatment for diabetes mellitus
结局指标
主要结局
weight change
时间窗: Change from baseline to 24 months
Body weight will be assessed on a digital scale to assess change in body weight over the 24 month intervention period.
次要结局
- cardiorespiratory fitness(0, 6, 12, 18, 24 months)
- dietary intake(0, 6, 12, 18, 24 months)
- physical activity energy expenditure(0, 6, 12, 18, 24 months)
- body composition(0, 6, 12, 18 24 months)
- psychosocial and behavioral measures(0, 6, 12, 18, 24 months)
研究者
John M. Jakicic, PhD
Professor
University of Pittsburgh