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

Diet Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06266468
• Other study ID #: STUDY00149178
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University of Kansas Medical Center
• Contact: Heather Gibbs, PhD
• Phone: 9139459138
• Email: hgibbs[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.;
• Child BMI =95%ile (obese children are referred for more intensive therapy).

Related Conditions & MeSH terms

• Diet Quality

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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