NCT06489262招募中不适用
Efficacy Trial of Healthy Together "Juntos": A Family-based Digital Lifestyle Intervention for Hispanic Adolescents and Their Parents
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index (BMI) in adolescents
研究概览
简要总结
The purpose of this study is to assess the efficacy of a family-based digital (web and mobile phone-based) program known as Healthy Together ("Juntos") in preventing increases in body mass index and improving moderate-to-vigorous physical activity, diet quality, and percentage body fat among Hispanic adolescents.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lives with participating biological parent or legal guardian;
- •Self-identifies as Hispanic;
- •Is between the ages of 12-15years old;
- •Has access to a smartphone;
- •Does not meet recommendations for physical activity as determined by a validated 2-item screener;
- •Does not meet recommendations for daily fruit and vegetable intake (proxy for diet quality) as determined by a validated 2-item screener;
- •Exceeds recommendations for screen time (proxy for sedentary behavior) as determined by a validated 6-item screener
- •Is the biological parent or legal guardian of and lives with the adolescent;
- •Self-identifies as Hispanic;
- •Has access to a smartphone;
排除标准
- •Has BMI <5th (underweight) or ≥95th percentile (obesity);
- •Has a parent-reported chronic medical condition (e.g., type 2 diabetes) that requires more intensive intervention;
- •Has parent-reported responses on a physical activity readiness questionnaire (PAR-Q) that indicates a serious health issue, and a physician does not approve participation;
- •Has a parent-reported cognitive or developmental delay (e.g., Down Syndrome) that may interfere with understanding program materials.
- •Provides PAR-Q responses that indicate a serious health issue and a physician does not approve participation;
- •Reports family plans to move out of South Florida during the study follow-up period
结局指标
主要结局
Change in Body Mass Index (BMI) in adolescents
时间窗: Baseline and up to 12 months
Will be measured in kg/m\^2
次要结局
- Change in Diet Quality in adolescents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool(Baseline and up to 12 months)
- Change in Moderate-to-Vigorous Physical Activity (MVPA) in parents(Baseline and up to 12 months)
- Change in Health-related Positive Parenting Practices measured by the Parenting Strategies for Eating and Activity Scale(Baseline and up to 12 months)
- Change in Percentage of Body Fat in adolescents(Baseline and up to 12 months)
- Change in Moderate-to-Vigorous Physical Activity (MVPA) in adolescents(Baseline and up to 12 months)
- Change in Diet Quality in parents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool(Baseline and up to 12 months)
- Change in Percentage of Body Fat in parents(Baseline and up to 12 months)
- Change in Parenting Practices measured by the Parental involvement Scale(Baseline and up to 12 months)
- Change in Communication measured by Parent Adolescent Communication Scale(Baseline and up to 12 months)
- Change in Body Mass Index (BMI) in parents(Baseline and up to 12 months)
研究者
Sara StGeorge
Associate Professor
University of Miami
研究点 (1)
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