SMART: A Social and Mobile Weight Control Program for Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 2
- 主要终点
- Change in weight status
研究概览
简要总结
The Social/Mobile Approach to Reduce Weight (SMART) study is a 24-month randomized control trial designed to evaluate the hypothesis that weight status at 24 months will be significantly better for the SMART intervention recipients than for those who receive the comparison condition.
详细描述
The focus of the SMART study is to develop an intervention to promote weight loss in overweight or obese young adults. The investigators will recruit college and university students to evaluate the effects of SMART on weight status and other metabolic, behavioral and psychosocial outcomes up to and including 24 months.
The Primary aim of the study is to evaluate between condition differences in weight status at 24 months.
Secondary aims will assess the impact of the SMART intervention on: Diet, physical activity, sedentary behaviors, quality of life and depression at 6, 12, 18 and 24 months; Anthropometric measures (BP, waist circumference) at 6, 12, 18 and 24 months; Differences in weight status at 6, 18 and 24 months; Level of satisfaction and amount of use of the intervention components.
These aims will be applied to overweight/obese young adults. Among overweight/obese young adults, the investigators will determine whether SMART produces 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 35 years
- •Intending to be available for a 24 month intervention
- •Full-time student enrollment at one of the designated San Diego college or university campuses: UCSD, SDSU, and CSU San Marcos
- •Facebook user or willingness to begin using Facebook
- •Owns personal computer
- •Owns mobile phone and uses text messaging
- •Willing to attend required research measurement visits in San Diego over the 2 year RCT
- •Participants must meet overweight and obesity criteria: 25 < BMI <35 kg/m2
- •English-speaking
- •Able to ambulate unassisted
排除标准
- •Those unable to provide informed consent
- •Those with a BMI of <25 kg/m2 or >35 kg/m2
- •Those who have a household member on the study staff
- •Those with any comorbidities of obesity who require immediate sub-specialist referral including pseudo-tumor cerebri, sleep apnea/hypoventilation syndrome, orthopedic problems, and meeting American Diabetes Association criteria for diabetes
- •Cardiovascular event within the last 6 months
- •Systolic BP at screening of >160 mmHg OR diastolic BP > 100 mmHg
- •Current treatment for malignancy other than non-melanoma skin cancer
- •Psychiatric or medical condition that prohibit compliance with study protocol, prescribed dietary changes and/or moderate physical activity
- •Current treatment for eating disorder
- •Taking medications that alter weight
- •Regular use of systemic steroids
- •Currently pregnant, gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months or intending to get pregnant over the next two years
- •Enrolled in or planning to enroll in another weight loss program
- •Past or planned (within the next 24 months) weight loss surgery
- •Current participation in a commercial weight loss program
- •Investigator discretion
- •Non-English speaking
- •Not able to ambulate unassisted
结局指标
主要结局
Change in weight status
时间窗: 24 months
次要结局
未报告次要终点
研究者
Kevin Patrick, MD, MS
Professor
University of California, San Diego