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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06266468
Enrollment
162
Registered
2024-02-20
Start date
2024-02-21
Completion date
2025-06-16
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Quality

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. 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.

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.

Interventions

BEHAVIORALNutricity

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

Sponsors

University of Kansas Medical Center
Lead SponsorOTHER
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The intervention study model is a 2-arm randomized control trial with a 1:1 allocation of parent/child dyad 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Child: Change in Diet Quality (Healthy Eating Index) From Baseline to 3 MonthsBaseline to 3 monthsChange in diet quality (Healthy Eating Index) from baseline to 3 months. 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. A positive change indicates a better outcome.

Secondary

MeasureTime frameDescription
Parent: Nutrition LiteracyBaseline, 3 monthsMeasured by the Nutrition Literacy Assessment Instrument (score ranges 0 to 42). Scores are interpreted as: \>39 good, 29-38: moderate, ≤ 28: poor.
Child: Body Mass IndexBaseline, 3 monthsCalculated from measured height and weight. Values can be plotted on the CDC's BMI-for-age growth charts to determine BMI-for-age percentile. Healthy Weight is between 5th percentile to less than 85th percentile.
Child: Skin CarotenoidBaseline, 3 monthsAssesses carotenoid status, a biomarker of fruit and vegetable intake. Scale ranges between 0 and 800. A higher score means a better outcome.
Parent: Feeding Behaviors of Parent and Children (BPFAS)Baseline, 3 monthsFeeding 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". Four scores are reported as 1) Frequency of Child Behavior (ranges 1-5, higher indicates more problem behaviors), 2) Number of Problematic Child Behaviors (ranges 0-25, higher indicates more problem behavior), 3) Frequency of Parent Behavior (ranges 1-5, higher indicates more problem behavior), and 4)Number of Problematic Parent Behaviors (ranges 0-10, higher indicates more problem behavior).
Parent: Mediation of Children's Media UseBaseline, 3 monthsA 16-item parent report of frequency of mediation of children's media use on a Likert scale (1=never and 5=always). Higher scores indicate higher parental mediation of children's media use.
Parent : Self-EfficacyBaseline, 3 monthsUses 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).
Parent: Nutrition AttitudesBaseline, 3 monthsAttitudes 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHeather Gibbs, PhD

University of Kansas Medical Center

Participant flow

Recruitment details

A total of 81 parent-child dyads (162 participants), were enrolled and randomized between 02/21/2024 and 03/13/2025. Each dyad consisted of one parent/caregiver and one child. Dyads were recruited through pediatric primary care clinics using multiple strategies (e.g. direct referrals, medical record review).

Baseline characteristics

Characteristic
Age, Continuous
Child Participants
2.58 Years
STANDARD_DEVIATION 1.4
Age, Continuous
Parent Participants
32.1 Years
STANDARD_DEVIATION 6.3
Child: Diet Quality (Healthy Eating Index)65.3 Range from 0 to 100
STANDARD_DEVIATION 12.2
Ethnicity (NIH/OMB)
Child Participants
Hispanic or Latino
70 Participants
Ethnicity (NIH/OMB)
Child Participants
Not Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Child Participants
Unknown or Not Reported
7 Participants
Ethnicity (NIH/OMB)
Parent Participants
Hispanic or Latino
39 Participants
Ethnicity (NIH/OMB)
Parent Participants
Not Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Parent Participants
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
Child Participants
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Child Participants
Asian
0 Participants
Race (NIH/OMB)
Child Participants
Black or African American
0 Participants
Race (NIH/OMB)
Child Participants
More than one race
2 Participants
Race (NIH/OMB)
Child Participants
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Child Participants
Unknown or Not Reported
19 Participants
Race (NIH/OMB)
Child Participants
White
35 Participants
Race (NIH/OMB)
Parent Participants
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Parent Participants
Asian
0 Participants
Race (NIH/OMB)
Parent Participants
Black or African American
0 Participants
Race (NIH/OMB)
Parent Participants
More than one race
2 Participants
Race (NIH/OMB)
Parent Participants
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Parent Participants
Unknown or Not Reported
39 Participants
Race (NIH/OMB)
Parent Participants
White
17 Participants
Sex: Female, Male
Child Participants
Female
23 Participants
Sex: Female, Male
Child Participants
Male
17 Participants
Sex: Female, Male
Parent Participants
Female
30 Participants
Sex: Female, Male
Parent Participants
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 800 / 82
other
Total, other adverse events
0 / 800 / 82
serious
Total, serious adverse events
0 / 800 / 82

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026