Diet QualityNCT06266468

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

A study testing Nutricity in people with Diet Quality, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Diet Quality
What is being tested?: Nutricity
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 162 participants
Where: 1 siteUnited States
Study dates: 21 Feb 2024to 16 Jun 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

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:

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

Read the 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.

Conditions: Diet Quality
Being tested: Nutricity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06266468
Study group	Role	What they receive
Intervention	Experimental	12 weeks of mobile intervention (website and text messaging) Receives: Behavioral: Nutricity
Waitlist	Placebo comparator	No intervention for 12 weeks, or until completion of 2nd study visit Receives: Behavioral: Nutricity

What is being measured

The primary outcome is the main question the study is designed to answer.

Child: Change in Diet Quality (Healthy Eating Index) From Baseline to 3 Months
Change 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.
Measured: Baseline to 3 months

Secondary outcomes (7)

Parent: Nutrition Literacy
Measured by the Nutrition Literacy Assessment Instrument (score ranges 0 to 42). Scores are interpreted as: >39 good, 29-38: moderate, ≤ 28: poor.
Measured: Baseline, 3 months
Child: Body Mass Index
Calculated 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.
Measured: Baseline, 3 months
Child: 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.
Measured: Baseline, 3 months
Parent: Feeding Behaviors of Parent and Children (BPFAS)
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". 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).
Measured: Baseline, 3 months
Parent: 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). Higher scores indicate higher parental mediation of children's media use.
Measured: Baseline, 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).
Measured: Baseline, 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.
Measured: Baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 202416 Jun 2025

First posted20 Feb 2024
Study start21 Feb 2024
Primary completion16 Jun 2025
Study completion16 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diet QualityStudies of the same condition, open and under way.
More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06266468
Sponsor's protocol ID: STUDY00149178
Other IDs: P20GM139733
Status last verified: Aug 2026
First submitted: 11 Jan 2024
Last updated: 27 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diet Quality trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children
ClinicalTrials.gov ID: NCT06266468
Acronym / sponsor ID: STUDY00149178
Conditions: Diet Quality
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 21 Feb 2024 (actual)
Primary completion: 16 Jun 2025 (actual)
Study completion: 16 Jun 2025 (actual)
First posted: 20 Feb 2024 (actual)
Results: Posted 27 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.
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.
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.
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:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Intervention	Experimental	Behavioral: Nutricity12 weeks of mobile intervention (website and text messaging)
Waitlist	Placebo comparator	Behavioral: NutricityNo intervention for 12 weeks, or until completion of 2nd study visit

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NutricityNutricity is a bilingual (English/Spanish) mobile website supplemented by an automated text-messaging system.	Behavioural	Intervention, Waitlist

Primary outcome

Child: Change in Diet Quality (Healthy Eating Index) From Baseline to 3 Months
Time frame: Baseline to 3 months
Change 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.

7 secondary outcomes

Parent: Nutrition Literacy
Time frame: Baseline, 3 months
Child: Body Mass Index
Time frame: Baseline, 3 months
Child: Skin Carotenoid
Time frame: Baseline, 3 months
Parent: Feeding Behaviors of Parent and Children (BPFAS)
Time frame: Baseline, 3 months
Parent: Mediation of Children's Media Use
Time frame: Baseline, 3 months
Parent : Self-Efficacy
Time frame: Baseline, 3 months
Parent: Nutrition Attitudes
Time frame: Baseline, 3 months

Results and safety

Results posted to the registry on 27 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	80	72
Waitlist	82	78

Primary outcome: Child: Change in Diet Quality (Healthy Eating Index) From Baseline to 3 Months

Time frame: Baseline to 3 months. Mean (Standard Deviation). Unit: Change in Healthy Eating Index Score

Measure	Intervention n = 36	Waitlist n = 39
Value	0.806 (10.8)	-1.97 (11.7)

Population analysed: 81 child participants enrolled. Missing data at follow up reflected in counts.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment date through 3 month data collection visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Waitlist	0 of 82 (0%)	0 of 82 (0%)	0 of 82

Limitations and caveats (from the sponsor): Data will be carried forward into a larger randomized controlled trial. Thus, analysis of the effect is not reported here and will be reported upon completion of the larger trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diet Quality

Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Active, not recruiting
Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery
Gastric Carcinoma, Gastroesophageal Junction Adenocarcinoma
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heather Gibbs, PhD principal investigator

University of Kansas Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nutricity in people with Diet Quality, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child: Change in Diet Quality (Healthy Eating Index) From Baseline to 3 Months (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06266468.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.