Clinical trial NCT06082830: Helping Educate and Advance Learning Through Healthy Bite-Sized Eating Strategies
Official title: Digital Intervention to Improve Diet Quality in Adolescents With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Obesity
Adolescent Overweight
Diet, Healthy
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: National Center for Advancing Translational Sciences (NCATS)
name: National Institutes of Health (NIH)
First posted: 2023-10-13
Enrollment: 210
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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).

Detailed description: 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.

Setting/Participants:

This is a single site study. Adolescents (N=70, aged 14-17 years) at risk for diet quality that is low or in need of improvement (Healthy Eating Index (HEI) \< 80) and with a history of having overweight or obesity (body mass index (BMI) between the 85th and 99th percentile on at least two occasions six months apart in the medical record in the last five years) will be invited to participate. Clinical measurements will be acquired at the Children's Hospital of Philadelphia (CHOP). Diet, urine, blood glucose, physical activity, and sleep data collection will take place in the home setting.

Study Interventions and Measures:

Adolescents and their parents will be randomized to receive a) usual care or b) a nutrition intervention with personal goals, meal timing, nutrition skills, and home food environment intervention components. The content for each component will be delivered through text messaging. Three 24-hr dietary recalls and the first morning urine void on two separate occasions will be collected at baseline and follow-up. HEI-2020 scores will be calculated and change in HEI-2020 will be the primary outcome. The urine Na:K will be quantified and change in Na:K will be the secondary outcome.

Eligibility criteria: 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.

Primary outcomes:
measure: Diet Quality
timeFrame: 6 weeks
Secondary outcomes:
measure: Urinary Concentration of Sodium (Na)
timeFrame: 6 weeks
measure: Urinary Concentration of Potassium (K)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jonathan A Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References: