Helping Educate and Advance Learning Through Healthy Bite-Sized Eating Strategies

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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: 1. Complete three-day 24-hour dietary recalls 2. Collect urine samples 3. 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).

Conditions:

Adolescent Obesity Adolescent Overweight Diet, Healthy

Study Start (Actual) 2024-08-01

Primary Completion (Estimated) 2024-11-01

Study Completion (Estimated) 2025-11-01

Enrollment (Estimated) 70

Study Type INTERVENTIONAL

Phase NA

Locations:

📍 Philadelphia, Pennsylvania, United States

Eligibility Criteria

Description

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Ages Eligible for Study: 14 Years to 17 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-10-09
First Submitted that Met QC Criteria2023-10-09
First Posted2023-10-13

Study Record Updates

Last Update Submitted that Met QC Criteria2024-05-24
Last Update Posted2024-05-28
Last Verified2024-05