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

NCT06082830 | Completed

• 2 other identifiers: 23-020988UL1TR001878
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Complete three-day 24-hour dietary recalls
2. 2.Collect urine samples
3. 3.Wear a continuous glucose monitor, sleep tracker, and physical activity tracker

Conditions

Adolescent Obesity; Adolescent Overweight; Diet, Healthy

Outcome Measures

Primary Outcomes (1)

• Diet Quality

  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.

  6 weeks

Secondary Outcomes (2)

• Urinary Concentration of Sodium (Na)

  6 weeks

• Urinary Concentration of Potassium (K)

  6 weeks

Study Arms (2)

Control

NO INTERVENTION

The control arm will not receive any intervention materials.

Intervention

EXPERIMENTAL

The trial duration will be four weeks. The intervention arm includes five components: personalized goal, meal timing, nutrition skills, home food environment, and engagement strategies. The specific number, design and content of the text messages for each component will be prepared and vetted by the investigators and by adolescents and parents through CHOP's Family Partners Program prior to study launch. The text messages will be sent through the REDCap Twilio integration.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

The intervention arm includes five components: 1. Personalized goal: Participants will complete an interview with a registered dietitian to review their baseline diet quality data and establish their personalized dietary goals. 2. Meal timing: Participants will receive information on why eating later at night is detrimental and specific strategies on how to limit eating past 8pm in the evening. 3. Nutrition skills: Participants will receive nutrition education and cooking skills text messages, using adolescent specific guidance from the Dietary Guidelines for Americans. 4. Home food environment: Participants will receive text messages on how to better select and prepare foods in the home environment (e.g., fruit and vegetable availability). 5. Engagement strategies: Researchers will design and implement text messages that recognize participant time and effort (e.g., text badges in recognition of completing the first study week).

Intervention

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jonathan A Mitchell, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of this pilot work, masking is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: October 1, 2024
• Primary Completion: June 14, 2025
• Study Completion: June 14, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)