Clinical trial NCT06266468: Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children
Official title: Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diet Quality
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.;

Primary outcomes:
measure: Change in Diet quality (Healthy Eating Index) (child)
timeFrame: Baseline and at 3 months
Secondary outcomes:
measure: Nutrition Literacy (parent)
timeFrame: Baseline and at 3 months
measure: Body Mass Index (child)
timeFrame: Baseline and at 3 months
measure: Skin Carotenoid
timeFrame: Baseline and at 3 months
measure: Feeding Behaviors of Parent and Children
timeFrame: Baseline and at 3 months
measure: Mediation of Children's Media Use
timeFrame: Baseline and at 3 months
measure: Parent Self-Efficacy
timeFrame: Baseline and at 3 months
measure: Parent Nutrition Attitudes
timeFrame: Baseline and at 3 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Heather Gibbs, PhD
role: PRINCIPAL_INVESTIGATOR
References: