NCT07027865

Brief Summary

Teens consume more added sugar than any other age group. Too much added sugar is associated with poor diet quality, obesity risk, and negative cardiometabolic outcomes. Behavioral interventions to improve dietary intake are needed, but are currently lacking for this age group. This study aims to test how feasible, acceptable, and effective a 12-week contextually-tailored health coaching program, called Sip \& Snack Better (SSB), is in reducing added sugar in teens, compared to a technology-only comparison. It will provide important information on how to improve dietary intake and reduce added sugar in teens. Additionally, measuring diet is very challenging in teens, so this study will also test the use of an objective biomarker (called the carbon isotope ratio (CIR)) as a measure of added sugar intake before, during, and after the 12-week study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

June 24, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

May 20, 2025

Last Update Submit

May 4, 2026

Conditions

Keywords

dietary intakeadded sugaradolescentsbehavior changedietary intake assessment

Outcome Measures

Primary Outcomes (3)

  • Changes in Added Sugar Intake

    Change in added sugar intake will be assessed using the carbon isotope ratio (CIR) as a objective measure of added sugar intake via breath, blood, and hair samples taken at baseline and post-intervention. Intent-to-treat analyses will be conducted using linear regression models to examine changes in CIR between intervention and control participants. A lower (i.e., more negative) CIR value indicates lower added sugar intake.

    Baseline to 12-weeks

  • Intervention Feasibility

    Feasibility will be assessed by session attendance (\>75%) and retention (\>80%) over the 12-week study.

    Baseline to 12-weeks

  • Intervention Acceptability

    Participants will report acceptability (\>80% rating of 4 or 5 on Likert scale questions) on a post-intervention acceptability questionnaire

    Baseline to 12-weeks

Secondary Outcomes (1)

  • Changes in Diet Quality

    Baseline to 12-weeks

Other Outcomes (3)

  • Feasibility of Breath CIR

    Baseline to 12-weeks

  • Predictive Accuracy of the Carbon Isotope Ratio (CIR) as an indicator of Added Sugar and Sugar Sweetened Beverage Intake

    Baseline to 12-weeks

  • CIR Biomarker Acceptability

    Baseline to 12-weeks

Study Arms (2)

Health Coaching Behavioral Intervention

EXPERIMENTAL

Behavioral intervention using health coaching and technology to improve dietary intake

Behavioral: Sip & Snack Better (SSB) Intervention

Technology-Only Comparison

OTHER

Digitally-delivered nutrition education only comparison arm

Other: Sip & Snack Better (SSB) Tech-Only Comparison

Interventions

Participants (teens 12-16 years) and their parent or legal guardian will participate in a 12-week health coaching intervention to reduce added sugar intake. Parents and teens will participate in 6 health coaching sessions (in weeks 1, 3, 5, 7, 9, and 12; 30-45 minutes, online via Zoom). Teens will participate in four in-person groups sessions (in weeks 2, 4, 6, and 8) and receive text-messages to reinforce intervention content.

Health Coaching Behavioral Intervention

Participants (teens 12-16 years) and their parent or legal guardian will participate in a 12-week technology-only comparison arm. Parents and teens will receive information about added sugar intake and healthy eating once via email or text message (based on preference) in weeks 1, 3, 5, 7, 9, and 12. Teens will receive informational text messages 3 times per week .

Technology-Only Comparison

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent is 18 years or older, and the legal guardian of the adolescent
  • Adolescent is between the ages of 12 and 16 years
  • Parents and adolescents have the ability to read, write, and understand English
  • Adolescents have a cell phone and are willing to use it to receive text messages and answer survey questions
  • Parents and adolescents live in the Philadelphia region and can attend in-person visits at the research center in North Philadelphia
  • Parents and adolescents can access video communication platforms (i.e., Zoom) via phone or computer
  • Parents and adolescents are willing to be randomized to either treatment condition
  • Adolescents exceed daily recommendations for added sugar intake (as assessed by dietary screener)

You may not qualify if:

  • Adolescent has a medical condition that influences weight status or added sugar intake (e.g., Type 1 or Type 2 diabetes)
  • Adolescent has a psychological or psychiatric condition that prevents study participation without individualized support (e.g., autism spectrum disorder)
  • Adolescent has been diagnosed with or has received/is receiving treatment for an eating disorder
  • Adolescent has been diagnosed with or has received/is receiving treatment for depression
  • Adolescent has dietary restrictions, dietary prescriptions, or dietary goals given by a health care provider that would influence weight or added sugar intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

RBM14 protein, humanSSB protein, humanMethods

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2025

First Posted

June 19, 2025

Study Start

June 24, 2025

Primary Completion

April 23, 2026

Study Completion

April 23, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations