COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Digital Intervention to Improve Diet Quality in Adolescents With Overweight or Obesity

Quick Facts

Study Start:2024-10-01
Study Completion:2025-06-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06082830

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Aged 14-17 years old.
  2. * At risk for diet quality that is poor or needs improvement (HEI score \< 80) determined by participants baseline 24-hour diet recall data.
  3. * 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.
  4. * Have access to a phone capable of receiving text messages.
  1. * History of an eating disorder diagnosis (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder, avoidant restrictive food intake disorder).
  2. * History of a condition that may alter dietary intake (e.g., diabetes, Celiac's disease, phenylketonuria, cystic fibrosis).
  3. * Regularly taking medications that may result in weight loss, appetite stimulation or suppression, and/or fluctuations in fluid status.
  4. * Currently being followed by a registered dietitian.
  5. * Pregnant or lactating females.
  6. * Have a parent, guardian, or family member that works for the Division of Gastroenterology, Hepatology, and Nutrition at CHOP.

Contacts and Locations

Principal Investigator

Jonathan A Mitchell, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Jonathan A Mitchell, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

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

Study Start Date2024-10-01
Study Completion Date2025-06-14

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2025-06-14

Terms related to this study

Additional Relevant MeSH Terms

  • Adolescent Obesity
  • Adolescent Overweight
  • Diet, Healthy