Center for Obesity Research and Education
Philadelphia, Pennsylvania, 19140, United States
NCT Number: NCT07027865
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.
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Notify Me12 year–16 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19140, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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 .
Time frame: Baseline to 12-weeks
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.
Time frame: Baseline to 12-weeks
Feasibility will be assessed by session attendance (>75%) and retention (>80%) over the 12-week study.
Time frame: Baseline to 12-weeks
Participants will report acceptability (>80% rating of 4 or 5 on Likert scale questions) on a post-intervention acceptability questionnaire
Time frame: Baseline to 12-weeks
Changes in diet quality will be assessed via Healthy Eating Index (HEI) derived from three 24-hour dietary recalls at baseline and post-intervention. HEI is scored on a scale from 0 to 100 with higher scores indicating higher diet quality.
Time frame: Baseline to 12-weeks
Feasibility of breath CIR to capture intervention adherence will be assessed via completion rates of breath samples (>80%). The sampling protocol collects three breath samples on five random sampling days at baseline and in weeks 3, 6, 9, and 12 (15 total breath samples over 12-weeks).
Time frame: Baseline to 12-weeks
Area under the curve (AUC) models will be used to determine how well each CIR sample type (blood, breath, hair, nails) captured changes in added sugar and sugar-sweetened beverage intake (derived from 24-hour dietary recalls). AUC ranges from 0 -1 and a higher AUC indicates better model fit.
Time frame: Baseline to 12-weeks
Participants will report on a scale of 1-5 how anxious or stressed they are before the collection (1= Very stressed or anxious, 5= Not at all stressed or anxious). After collection, participants will report on a scale of 1-5 how comfortable they felt during the collection (1= very uncomfortable, 5= very comfortable) and how difficult or burdensome they found the collection method (1=very difficult or very burdensome, 5=not at all difficult or burdensome). After all data are collected participants will rank the collection methods in order of preference (1= top choice, 4= last choice) and report (yes/no) if they would be willing to provide each type again in a subsequent study (breath, blood, hair, nail).
Temple University
Other
Targeting Added Sugar to Improve Dietary Intake in High-risk Adolescents
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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