Digital Intervention to Improve Diet Quality in Adolescents With Overweight or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Diet Quality
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of a mobile health intervention in adolescents (14-17 years) with overweight or obesity.
The main question[s] it aims to answer are: 1) is a digital-based diet quality intervention for adolescents with overweight or obesity feasible and 2) is there preliminary effectiveness in improving diet quality?
Participants will:
- Complete three-day 24-hour dietary recalls
- Collect urine samples
- Wear a continuous glucose monitor, sleep tracker, and physical activity tracker
Researchers will compare control and intervention groups to see if diet quality and meal timing traits improve as assessed by 24-hour dietary recalls, a novel urine biomarker, and continuous glucose monitoring (CGM).
详细描述
Background:
Improving diet quality is an essential component for the treatment of adolescent obesity. Pediatric providers are recommended to incorporate nutrition recommendations as part of adolescent obesity treatment, but time and knowledge are barriers. Digital-based interventions have been shown to improve fruit and vegetable intake in adolescents. However, it is unknown if a digital-based diet quality intervention is feasible or effective for adolescents with overweight or obesity.
Objectives: (primary and important secondary objectives) The overarching objective of this pilot study is to demonstrate if a digital-based diet quality intervention for adolescents with overweight or obesity is feasible and if there is preliminary effectiveness that diet quality and meal timing traits improves as assessed by 24-hr dietary recalls, a novel urine biomarker, and continuous glucose monitoring (CGM).
Study Design:
A two-arm pilot randomized controlled trial (RCT) falling under the preparation phase of the Multiphase Optimization Strategy (MOST) framework.
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
- None
盲法说明
Due to the nature of this pilot work, masking is not feasible.
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 14-17 years old.
- •At risk for diet quality that is poor or needs improvement (HEI score < 80) determined by participants baseline 24-hour diet recall data.
- •Body mass index between the 85th and 99th percentile for age and sex on at least two occasions at least six months apart in the medical record in the last five years.
- •Have access to a phone capable of receiving text messages.
排除标准
- •History of an eating disorder diagnosis (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder, avoidant restrictive food intake disorder).
- •History of a condition that may alter dietary intake (e.g., diabetes, Celiac's disease, phenylketonuria, cystic fibrosis).
- •Regularly taking medications that may result in weight loss, appetite stimulation or suppression, and/or fluctuations in fluid status.
- •Currently being followed by a registered dietitian.
- •Pregnant or lactating females.
- •Have a parent, guardian, or family member that works for the Division of Gastroenterology, Hepatology, and Nutrition at CHOP.
结局指标
主要结局
Diet Quality
时间窗: 6 weeks
For aim 1, the primary outcome will be change in overall Healthy Eating Index (HEI) 2020 score. The HEI-2020 ranges from 0-100; a greater score indicates greater adherence to the 2020 - 2025 Dietary Guidelines for Americans and better diet quality. HEI-2020 scores will be derived from dietary data collected through three 24-hour dietary recalls at baseline and follow-up and processed using Nutrient Data System for Research software.
次要结局
- Urinary Concentration of Sodium (Na)(6 weeks)
- Urinary Concentration of Potassium (K)(6 weeks)