# Biomarker Assessment of Adherence and Effectiveness in a Randomized Controlled Trial to Reduce Added Sugar Intake in Adolescents

> **NIH NIH R03** · TEMPLE UNIV OF THE COMMONWEALTH · 2024 · $139,504

## Abstract

PROJECT ABSTRACT
Added sugar (AS) is a critically important dietary target for intervention in adolescents; it contains excess
calories with no nutritional value and is independently associated with chronic disease risk. Adolescents
consume more AS than any other age group and are at a unique phase in the life course where improving diet
could have a significant influence on overall health into adulthood. However, capturing dietary change remains
a paramount challenge in the field of nutrition and this is particularly true for overconsumed nutrients like AS
that are highly susceptible to reporting error and social desirability bias. The challenge of dietary self-report is
also pronounced in behavioral trials where issues like participant burden, repeated measures, and small
sample sizes have significant impacts on the ability to accurately assess outcomes. The carbon stable isotope
ratio (CIR) is a low-burden and valid measure of AS and sugar-sweetened beverage (SSB) intake that
warrants additional investigation in dietary interventions. Most of the evidence on CIR to date is derived from
controlled feeding studies and observational trials using blood and hair CIR. Breath CIR has recently been
validated as a measure of short and long-term AS intake and provides an exciting new avenue to explore AS
intervention adherence and effectiveness in behavioral trials. Thus, the purpose of this R03 is to examine CIR
from breath as an indicator of intervention adherence (i.e., short-term intake) and intervention effectiveness
(i.e., change over time). Additionally, this study aims to assess the differential feasibility, acceptability, and
sensitivity to change among CIR from breath, blood, and hair samples to inform work in future trials. This R03
study will be mapped onto a randomized controlled trial (RCT) in an ongoing K01 study. Adolescents (n=70)
12-16 years will be randomized to a 12-week behavioral intervention to reduce AS intake (n=35), or a
nutritional education comparison (n=35). This R03 study will 1) Assess the feasibility and efficacy of using daily
breath CIR (fasting morning, postprandial afternoon, and evening) to capture intervention adherence via
repeated sampling over 12-weeks (at baseline, and in weeks 3, 6, 9, and 12); 2) Examine AS intervention
effectiveness based on changes in breath CIR from baseline to end-of-intervention (12-weeks) between
intervention and control participants; and 3) Compare feasibility, acceptability, and sensitivity to change of
breath, blood, and hair CIR to capture change in AS over 12 weeks. This R03 will enhance the impact of the
PI's existing K01 by adding innovative breath CIR measures and analyses, which will provide robust evidence
for objectively assessing AS intervention adherence and effectiveness. Additionally, this study will test
assessment approaches that could reduce participant burden and eliminate reliance on dietary self-report,
resulting in more efficacious strategies for populations at grea...

## Key facts

- **NIH application ID:** 10985627
- **Project number:** 1R03HL171171-01A1
- **Recipient organization:** TEMPLE UNIV OF THE COMMONWEALTH
- **Principal Investigator:** Gina L. Tripicchio
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $139,504
- **Award type:** 1
- **Project period:** 2024-08-16 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10985627

## Citation

> US National Institutes of Health, RePORTER application 10985627, Biomarker Assessment of Adherence and Effectiveness in a Randomized Controlled Trial to Reduce Added Sugar Intake in Adolescents (1R03HL171171-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10985627. Licensed CC0.

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