Adolescent ObesityHEALTHY BITESNCT06082830
Helping Educate and Advance Learning Through Healthy Bite-Sized Eating Strategies
A study testing Intervention in people with Adolescent Obesity and Adolescent Overweight, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Adolescent Obesity, Adolescent Overweight, Diet, Healthy
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 14 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
Official title: Digital Intervention to Improve Diet Quality in Adolescents With Overweight or Obesity
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?
Read more
Participants will:
- Complete three-day 24-hour dietary recalls
- Collect urine samples
- 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).
Read the 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.
- Conditions
- Adolescent Obesity, Adolescent Overweight, Diet, Healthy
- Being tested
- Intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The intervention arm includes five components:
- Personalized goal: Participants will complete an interview with a registered dietitian to review their baseline diet quality data and establish their personalized dietary goals.
- 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.
- Nutrition skills: Participants will receive nutrition education and cooking skills text messages, using adolescent specific guidance from the Dietary Guidelines for Americans.
- 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).
- 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Outcome measure data were collected for adolescents only, not caregivers.
Measured: 6 weeks
Secondary outcomes (2)
Urinary Concentration of Sodium (Na)
For aim 2, outcome 2 will be change in urinary Na. Participants will collect their urine from their first morning voids at baseline and follow-up. The urine will be sent to CHOP for biobanking and proton nuclear magnetic resonance (NMR) will be used to measure Na. This provides an objective measure of high sodium (e.g., processed foods) in the diet. Outcome measure data were collected for adolescents only, not caregivers.
Measured: 6 weeks
Urinary Concentration of Potassium (K)
For aim 2, outcome 3 will be change in urinary K. Participants will collect their urine from their first morning voids at baseline and follow-up. The urine will be sent to CHOP for biobanking and proton nuclear magnetic resonance will be used to measure K. This provides an objective measure of high potassium (e.g., fruits and vegetables) in the diet. Outcome measure data were collected for adolescents only, not caregivers.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Oct 2024
- Primary completion14 Jun 2025
- Study completion14 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jonathan A Mitchell, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082830
- Sponsor's protocol ID
- 23-020988
- Other IDs
- UL1TR001878
- Acronym
- HEALTHY BITES
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2023
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participants will be asked to collect their first morning void on two occasions at baseline and follow-up. Participants will be provided with towelette(s) and a pre-labeled urine collection cup and provided with sex-specific instructions to collect clean-catch urine. Samples will be shipped from participants' homes to the CHOP Biorepository Center for processing, aliquoting, and biobanking. De-identified samples will be shipped to Penn State University for proton nuclear magnetic resonance (NMR) analysis.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intervention to Improve Diet Quality in Adolescents With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06082830
- Acronym / sponsor ID
- HEALTHY BITES / 23-020988
- Conditions
- Adolescent Obesity, Adolescent Overweight, Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 14 Jun 2025 (actual)
- Study completion
- 14 Jun 2025 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Complete three-day 24-hour dietary recalls
- Collect urine samples
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control arm will not receive any intervention materials. |
| Intervention | Experimental | Behavioral: InterventionThe 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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). | Behavioural | Intervention |
Primary outcome
Diet Quality
Time frame: 6 weeks
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. Outcome measure data were collected for adolescents only, not caregivers.
2 secondary outcomes
Urinary Concentration of Sodium (Na)
Time frame: 6 weeks
Urinary Concentration of Potassium (K)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The participants will be asked to collect their first morning void on two occasions at baseline and follow-up. Participants will be provided with towelette(s) and a pre-labeled urine collection cup and provided with sex-specific instructions to collect clean-catch urine. Samples will be shipped from participants' homes to the CHOP Biorepository Center for processing, aliquoting, and biobanking. De-identified samples will be shipped to Penn State University for proton nuclear magnetic resonance (NMR) analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan A Mitchell, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Adolescent Obesity and Adolescent Overweight, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Quality (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.