Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children

The overall objective of this application is to pilot test an mHealth nutrition intervention within pediatric clinics serving Latino families and evaluate its potential for implementation. The investigators hypothesize the intervention will improve child diet quality and will be feasible for use within the clinic setting. To test this hypothesis, the investigators will pursue 3 specific aims and 1 exploratory aim:

1. Aim 1: Pilot Nutricity with 40 Latino families (English or Spanish speaking) vs. 40 waitlist control in primary care clinics and estimate differences in child diet quality at 3 month's post Nutricity exposure. Preliminary data will inform power calculations for a future larger Nutricity intervention.
2. Aim 2: Evaluate other individual (dyad) level factors including reach, engagement, and changes in secondary effectiveness outcomes (e.g. nutrition literacy, BMI, skin carotenoid, psychosocial constructs) at 3 months post exposure.
3. Aim 3: Evaluate organizational-level factors (adoption, implementation, and organizational-level maintenance) in Latino-serving pediatric clinics that may support or inhibit future uptake of Nutricity. The investigators will seek to understand the context of interventions and scalability to other clinics using mixed methods.
4. Exploratory Aim 1: Explore the relationship among nutrition literacy, psychosocial constructs and diet quality outcomes; and explore how engagement and satisfaction influence outcomes.

Study Overview

• Status: Completed
• Conditions: Diet Quality
• Intervention / Treatment: Behavioral: Nutricity

Detailed Description

There are three phases of participation in this study:

Phase 1 (Baseline): Participating parent and child dyads will be asked to come to the clinic or research lab 1 time for procedures and assessments that will help the investigator assess nutrition knowledge and eligibility. Assessment collected at this time will include: 1) Height/Weight: Parent and child will have their height and weight measured; 2) Demographics: survey with questions including items such as name, date of birth and race; 3)Two Nutrition Questionnaires: Nutrition Literacy Assessment Instrument (NLit, measures nutrition knowledge of nutrition and health, energy sources in food, household food measurement, food labels/numbers, food groups and consumer skills) and a food intake screening survey; 4)24-hour Recall: Parents will be asked questions about their child's current diet over the last 24 hours. For children who eat meals at school or daycare, researchers may ask parents to provide forms for the child's teacher or daycare provider to record the meals they eat while there. Parents will also be asked to do two additional recall during the study that will be done with researchers over the phone; 5)Resonance Raman Spectroscopy (Veggie Meter): During this assessment, the veggie meter will apply gentle pressure to the pad of the child's fingertip to put it in close contact with light, to detect and measure carotenoid in the blood. Three, 10-45 second measurements are taken and averaged for the recorded score. Phase 2 (Nutricity): During this phase participants will use their smartphone or tablet to access the Nutricity website to potentially increase nutrition literacy and set nutrition goals by text message. Participants will have their own user name and password to access the site. This phase will last approximately 3 months. Phase 3 (End Study): Participant dyads will be asked to come to the research lab 1 time to perform the same procedures and assessments completed in the baseline visit as well as one exit survey.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age (of parent) > 18 years;
• Parent or guardian of a child between 1-5 years old;
• Hispanic/Latino;
• English or Spanish speaking;
• Primary food decision-maker for the home;
• Internet connectivity at home (smart phone is adequate);
• Owns a device for accessing internet at home.

Exclusion Criteria:

• Overt cognitive or psychiatric illness;
• Visual impairments that preclude viewing educational materials and using a tablet/device;
• Child illness requiring a highly restrictive diet, such as type 1 diabetes, renal disease, celiac disease, etc.;
• Another parent/guardian-child dyad in the household is enrolled in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 12 weeks of mobile intervention (website and text messaging)	Behavioral: Nutricity; Nutricity is a bilingual (English/Spanish) mobile website supplemented by an automated text-messaging system.
Placebo Comparator: Waitlist; No intervention for 12 weeks, or until completion of 2nd study visit	Behavioral: Nutricity; Nutricity is a bilingual (English/Spanish) mobile website supplemented by an automated text-messaging system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diet quality (Healthy Eating Index) (child)	Healthy Eating Index (HEI) calculated from nutrient data derived from 2, 24-hour recalls. Healthy Eating Index (HEI) scores range from 0 to 100. A score of 100 means a better outcome, reflecting that foods align with key dietary recommendations and dietary patterns published in the Dietary Guidelines.	Baseline and at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition Literacy (parent)	Measured by the Nutrition Literacy Assessment Instrument (score ranges 0 to 42). Scores are interpreted as: >39 good, 29-38: moderate, ≤ 28: poor.	Baseline and at 3 months
Body Mass Index (child)	Calculated from measured height and weight. Body Mass Index can range from ≤18.5 to ≥30. A Body Mass Index between 18.5 and 24.9 is within the Healthy Weight range.	Baseline and at 3 months
Skin Carotenoid	Assesses carotenoid status, a biomarker of fruit and vegetable intake. Scale ranges between 0 and 800. A higher score means a better outcome.	Baseline and at 3 months
Feeding Behaviors of Parent and Children	Behavioral Pediatrics Feeding Assessment Scale (BPFAS): A 35-item parent report of child mealtime and feeding behaviors- this scale examines the frequency of child and parent behaviors on a Likert scale (1=never and 5=always) and whether or not each item is a problem with "yes" or "no".	Baseline and at 3 months
Mediation of Children's Media Use	A 16-item parent report of frequency of mediation of children's media use on a Likert scale (1=never and 5=always).	Baseline and at 3 months
Parent Self-Efficacy	Uses a valid 9-item survey, grouping parents into 3 categories (0-<1.5 not at all/slightly confident; 1.5 - <2.5 very confident; 2.5 - 3 extremely confident).	Baseline and at 3 months
Parent Nutrition Attitudes	Attitudes of parents toward healthy eating. Measured using an 8-item measure, scored on a range of -2 to +2, with positive scores corresponding with positive attitudes.	Baseline and at 3 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Heather Gibbs, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00149178

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No