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

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. 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

Interventions

BEHAVIORAL

Intervention

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).

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Children's Hospital of Philadelphia

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2025-06-14

Completion

2025-06-14

Countries

• United States

Study Locations