Targeting Added Sugar to Improve Dietary Intake in High-risk Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Added Sugar Intake
研究概览
简要总结
Teens consume more added sugar than any other age group. Too much added sugar is associated with poor diet quality, obesity risk, and negative cardiometabolic outcomes. Behavioral interventions to improve dietary intake are needed, but are currently lacking for this age group. This study aims to test how feasible, acceptable, and effective a 12-week contextually-tailored health coaching program, called Sip & Snack Better (SSB), is in reducing added sugar in teens, compared to a technology-only comparison. It will provide important information on how to improve dietary intake and reduce added sugar in teens. Additionally, measuring diet is very challenging in teens, so this study will also test the use of an objective biomarker (called the carbon isotope ratio (CIR)) as a measure of added sugar intake before, during, and after the 12-week study.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent is 18 years or older, and the legal guardian of the adolescent
- •Adolescent is between the ages of 12 and 16 years
- •Parents and adolescents have the ability to read, write, and understand English
- •Adolescents have a cell phone and are willing to use it to receive text messages and answer survey questions
- •Parents and adolescents live in the Philadelphia region and can attend in-person visits at the research center in North Philadelphia
- •Parents and adolescents can access video communication platforms (i.e., Zoom) via phone or computer
- •Parents and adolescents are willing to be randomized to either treatment condition
- •Adolescents exceed daily recommendations for added sugar intake (as assessed by dietary screener)
排除标准
- •Adolescent has a medical condition that influences weight status or added sugar intake (e.g., Type 1 or Type 2 diabetes)
- •Adolescent has a psychological or psychiatric condition that prevents study participation without individualized support (e.g., autism spectrum disorder)
- •Adolescent has been diagnosed with or has received/is receiving treatment for an eating disorder
- •Adolescent has been diagnosed with or has received/is receiving treatment for depression
- •Adolescent has dietary restrictions, dietary prescriptions, or dietary goals given by a health care provider that would influence weight or added sugar intake
研究组 & 干预措施
Health Coaching Behavioral Intervention
Behavioral intervention using health coaching and technology to improve dietary intake
干预措施: Sip & Snack Better (SSB) Intervention (Behavioral)
Technology-Only Comparison
Digitally-delivered nutrition education only comparison arm
干预措施: Sip & Snack Better (SSB) Tech-Only Comparison (Other)
结局指标
主要结局
Changes in Added Sugar Intake
时间窗: Baseline to 12-weeks
Change in added sugar intake will be assessed using the carbon isotope ratio (CIR) as a objective measure of added sugar intake via breath, blood, and hair samples taken at baseline and post-intervention. Intent-to-treat analyses will be conducted using linear regression models to examine changes in CIR between intervention and control participants. A lower (i.e., more negative) CIR value indicates lower added sugar intake.
Intervention Feasibility
时间窗: Baseline to 12-weeks
Feasibility will be assessed by session attendance (\>75%) and retention (\>80%) over the 12-week study.
Intervention Acceptability
时间窗: Baseline to 12-weeks
Participants will report acceptability (\>80% rating of 4 or 5 on Likert scale questions) on a post-intervention acceptability questionnaire
次要结局
- Changes in Diet Quality(Baseline to 12-weeks)