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

NCT06266468 | Completed

• 1 other identifier: STUDY00149178
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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. 4.Exploratory Aim 1: Explore the relationship among nutrition literacy, psychosocial constructs and diet quality outcomes; and explore how engagement and satisfaction influence outcomes.

Conditions

Diet Quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Nutrition Literacy (parent)

  Baseline and at 3 months

• Body Mass Index (child)

  Baseline and at 3 months

• Skin Carotenoid

  Baseline and at 3 months

• Feeding Behaviors of Parent and Children

  Baseline and at 3 months

• Mediation of Children's Media Use

  Baseline and at 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

12 weeks of mobile intervention (website and text messaging)

Behavioral: Nutricity

Waitlist

PLACEBO COMPARATOR

No intervention for 12 weeks, or until completion of 2nd study visit

Behavioral: Nutricity

Interventions

Nutricity BEHAVIORAL

Nutricity is a bilingual (English/Spanish) mobile website supplemented by an automated text-messaging system.

Intervention; Waitlist

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Officials

• Heather Gibbs, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention study model is a 2-arm randomized control trial with a 1:1 allocation of participants to the treatment group (Nutricity) or the control group (usual care without Nutricity). After 12 weeks in the control group, participants will be introduced to Nutricity.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 20, 2024
• Study Start: February 21, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

US (1)