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临床试验/NCT03907462
NCT03907462已完成不适用

SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 638 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
638
试验地点
2
主要终点
Change in Weight

研究概览

简要总结

The SMART 2.0 study is a 24-month trial designed to evaluate the impact of the intervention with technology and personal health coaching or with technology alone on objectively measured weight among overweight young adults in a university setting over 24 months compared to a control group. The investigators hypothesize that both interventions will significantly improve weight compared to the control group, and the group receiving personal health coaching will experience the greatest improvement.

详细描述

Weight gain is an important issue for young adults. Throughout the transition from adolescence to early adulthood, young adults encounter multiple stressors and influences that can contribute to weight gain. In turn, weight gain leads to increased risk of cardiovascular disease, diabetes, and other health issues. Thus, there is a critical need to advance our understanding of how to develop and deploy multimodal, technology-based weight-loss interventions that have the potential for long-term effects and widespread dissemination among young adults.

The SMART 2.0 study is a 24-month (96 week) parallel-group randomized control trial designed to evaluate the impact of the interventions on objectively measured weight in kg over 24 months compared to a control group. The study will recruit 642 overweight/obese young adults aged 18-35 at universities in San Diego, CA. Participants will be randomly assigned to one of three groups for a 24-month study period. The three groups include: 1) SMART 2.0 with a consumer-level wearable and scale, text messaging, social media, and technology-based health coaching; 2) SMART 2.0 with a consumer-level wearable and scale, text messaging, and social media; and 3) a control group with a consumer-level wearable and scale alone. Theory- and evidence-based content will be framed around a minimum goal of 5-10% weight loss through increased energy expenditure, decreased energy intake, and adequate sleep. Additionally, participants will be encouraged to lose 1 to 2 pounds per week until they reach a body mass index (BMI) below 25 kg/m2. Once a participant reaches a BMI less than 25 kg/m2 the goal will be to maintain their weight loss.

SMART 2.0 uses a fully integrated system of modalities that includes: 1) a popular consumer-level wearable (e.g., Fitbit Charge 3), wireless scale (e.g., Aria Scale), and corresponding app (e.g., the Fitbit app); 2) a highly tailored and interactive text messaging system; 3) multiple social media streams (e.g., Facebook, Facebook Messenger, Instagram, and Twitter); and 4) social network mechanisms of influence. The consumer-level devices and app will be used to self-monitor behavior, and their data will be passively acquired in real-time. Algorithms will be used to automatically deliver text messages to support individually tailored goal setting, performance feedback, and goal review in a highly dynamic style that reflects participants' behavioral progress towards achieving a minimum goal of 5% weight loss. Participants will be encouraged to share their data and behavioral progress with others via social networking tools. Social network mechanisms of influence will be used both within the study-space, to elicit participant-to-participant and health coach-to-participant support, as well as outside the study-space, to invoke social support and accountability from strong ties known to be important for long-term behavior change. Additionally, one group will receive monthly technology-mediated and real-time personal health coaching that is theory- and evidence-based.

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
Double (Investigator, 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

入选标准

  • Age 18 to 35 years
  • Intending to be available for a 24 month intervention
  • Affiliated with either University of California, San Diego (UCSD), San Diego State University (SDSU), or California State University, San Marcos (CSUSM) as a student, faculty, or staff
  • Willing and able to use social media
  • Willing and able to use a smartphone and text messaging
  • Willing and able to use the wearable, scale, and corresponding app
  • Willing and able to attend measurement visits over the 2 year intervention
  • Willing and able to engage in moderate to vigorous physical activity
  • Overweight or obese, but not severely obese (25 >= BMI < 40 kg/m2)

排除标准

  • Any comorbidities of obesity that require a clinical referral including eating disorders, pseudotumor cerebri, sleep apnea or hypoventilation syndrome, orthopedic problems, and meeting American Diabetes Association criteria for diabetes
  • Psychiatric or medical conditions that prohibit compliance with the study protocol
  • Had a cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
  • Currently being treated for a malignancy (other than non-melanoma skin cancer)
  • Currently being treated and/or have an eating disorder
  • Planning to have a weight loss surgery in the next 24 months (e.g., liposuction, lap band, gastric bypass)
  • Pregnant, gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, or actively planning pregnancy within the next 24 months
  • Prescribed physical activity and/or dietary changes
  • Prescribed medications that alter weight
  • Enrolled in or planning to enroll in a weight loss program during the study period
  • Lost more than 15 pounds within the past 3 months

结局指标

主要结局

Change in Weight

时间窗: Baseline, 24 months

Objectively measured weight in kilograms.

次要结局

  • Change in Body Mass Index(Baseline, 24 months)
  • Percent Weight Change(Baseline, 24 months)
  • Percentage of Participants Who Lost at Least 3% of Their Weight From Baseline(Baseline, 24 months)
  • Percentage of Participants Who Lost at Least 5% of Their Weight From Baseline(Baseline, 24 months)
  • Change in Waist Circumference(Baseline, 24 months)
  • Change in Waist-to-hip Ratio(Baseline, 24 months)
  • Change in Bone Mineral Density(Baseline, 24 months)
  • Change in Systolic Blood Pressure(Baseline, 24 months)
  • Change in Diastolic Blood Pressure(Baseline, 24 months)
  • Change in Cardiorespiratory Fitness(Baseline, 24 months)
  • Change in Flexibility(Baseline, 24 months)
  • Change in Grip Strength(Baseline, 24 months)
  • Physical Activity(For 7 days, at 24 months)
  • Anxiety(Baseline, 24 months)
  • Self-esteem(Baseline, 24 months)
  • Quality of Well-being(Baseline, 24 months)
  • Body Image(Baseline, 24 months)
  • Change in Body Composition(Baseline, 24 months)
  • Change in Physical Activity(Baseline, 24 months)
  • Sleep(Through study completion, up to 24 months)
  • Change in Sleep(Baseline, 24 months)
  • Resting Heart Rate(Through study completion, up to 24 months)
  • Change in Resting Heart Rate(Baseline, 24 months)
  • Sedentary Behavior(For 7 days, at 24 months)
  • Change in Sedentary Behavior(Baseline, 24 months)
  • Diet History Questionnaire III(Baseline, 24 months)
  • Weight Management Practices(Baseline, 24 months)
  • Strategies for Weight Management Questionnaire(Baseline, 24 months)
  • Assessment of Eating Behaviors(Baseline, 24 months)
  • Daily Meal Patterns(Baseline, 24 months)
  • Healthy Eating: Change Strategies(Baseline, 24 months)
  • Physical Activity: Change Strategies(Baseline, 24 months)
  • Physical Activity Neighborhood Environment(Baseline, 24 months)
  • Social Support for Healthy Eating Habits(Baseline, 24 months)
  • Social Support for Physical Activity(Baseline, 24 months)
  • Depression(Baseline, 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Job Godino

Assistant Professor

University of California, San Diego

研究点 (2)

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