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: Enrolling by invitation

Administrative data

• NCT number: NCT06266468
• Other study ID #: STUDY00149178
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• 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.;

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
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

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