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临床试验/NCT03986190
NCT03986190已完成不适用

Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents

University of Miami1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in Adolescents Physical Activity

研究概览

简要总结

The purpose of the study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile phone-based) program to improve physical activity levels and quality dietary intake among Hispanic parent-adolescent dyads.

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 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Female and male adolescents whose primary caregiver self-identifies as Hispanic
  • •Adolescent is between the ages of 12-15;
  • •Adolescent lives with an adult primary caregiver willing to participate;
  • •Both parent and adolescent have smartphone/mobile device with internet access;
  • •Adolescent does not meet recommendations for fruit and vegetable intake (proxy for overall diet quality) as determined by a validated two-item screener;
  • •Adolescent does not meet physical activity guidelines as determined by responses on a validated two-item screener AND self-reports engaging in >2 hours/day of screen time (proxy for overall sedentary behavior) using three items.

排除标准

  • •Adolescent's body mass index for age and gender is ≥ 95th percentile ("obese" range);
  • •Adolescent has a chronic medical condition (e.g., type 2 diabetes) that requires intensive lifestyle modification;
  • •Adolescent has a diagnosed developmental delay that would interfere with understanding program materials;
  • •Parent or adolescent has a diagnosed medical or psychiatric condition and is currently taking medications that would interfere with changes to physical activity or diet (e.g., adolescent is diagnosed with Attention Deficit Hyperactivity Disorder and is currently on stimulant medication);
  • •Family is planning to move out of the South Florida during the study follow-up period

研究组 & 干预措施

Healthy Juntos Intervention Condition

Experimental

Parent-adolescent dyads randomized to the Healthy Juntos intervention condition will access a program that includes didactic, behavioral, and positive parenting content from their smartphones for 8 weeks.

干预措施: Healthy Juntos (Behavioral)

Control Group

No Intervention

This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites which they may access at their discretion.

结局指标

主要结局

Change in Adolescents Physical Activity

时间窗: Baseline, up to 2 months

Adolescents will self-report physical activity using the Youth Activity Profile.

Change in Adolescent Sedentary Behavior

时间窗: Baseline, 2 months

Adolescents will self-report sedentary behavior using the Youth Activity Profile.

Change in Adolescents Dietary Intake (Sugar)

时间窗: Baseline, up to 2 months

Adolescent-parent dyads will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.

Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables)

时间窗: Baseline, 2 months

Adolescents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute.

次要结局

  • Change in Parents Dietary Intake (Sugar)(Baseline, up to 2 months)
  • Change in Parent Physical Activity.(Baseline, up to 2 months)
  • Change Parent Sedentary Behavior(Baseline, up to 2 months)
  • Change in Parents Dietary Intake (i.e., Fruits/Vegetables)(Baseline, up to 2 months)

研究者

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

Sara StGeorge

Assistant Professor of Public Health Sciences

University of Miami

研究点 (1)

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