Nutricity for Healthy Eating

Overseen By Heather Gibbs, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Cognitive illness, Psychiatric illness, Visual impairments, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health program called Nutricity to determine if it can improve the eating habits of young Latino children. Researchers aim to find out if a website and text messages can help families choose healthier foods. Participants will join one of two groups: one will use the Nutricity program for 12 weeks, while the other will be on a waitlist. Families who speak English or Spanish, have a child aged 1-5, and are the primary decision-makers for food purchases might be a good fit. As an unphased trial, this study offers families the chance to contribute to innovative research that could make healthy eating more accessible.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on nutrition and diet, so it's unlikely that medication changes are required.

What prior data suggests that the Nutricity intervention is safe for use in pediatric clinics?

Research has shown that Nutricity, a mobile health nutrition program, has been studied for usability. Specific safety information from past studies is limited. However, because researchers are testing Nutricity with families, it is likely considered low-risk.

It is important to note that Nutricity is not a drug or medical device. It is a program that uses mobile technology to improve diet quality. Such programs are usually safe because they focus on education and support rather than medications or surgeries.

Some studies have used similar mobile and web-based programs to encourage healthy eating. These programs generally do not raise serious safety concerns. They aim to promote healthy habits, which are naturally safe.

In summary, while direct safety data for Nutricity is limited, similar programs have been well-tolerated, suggesting that Nutricity is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Nutricity is unique because it leverages digital technology to promote healthy eating habits through a mobile intervention involving a website and text messaging. Unlike traditional methods that might include dietary counseling or in-person sessions, Nutricity delivers personalized guidance directly to users’ devices, making it more accessible and potentially more engaging for individuals. Researchers are excited about this approach because it can offer real-time support and motivation, which might lead to better adherence to healthy eating practices and more sustainable lifestyle changes.

What evidence suggests that Nutricity might be an effective treatment for improving child diet quality?

Research has shown that Nutricity, a mobile health nutrition program, may help improve children's diets. In earlier studies, the Healthy Eating Index, which measures diet quality, showed positive changes in those using Nutricity. This trial will test Nutricity as part of an intervention arm, involving parents and children through a bilingual mobile app, aiming to enhance understanding of nutrition and eating habits. Although more research is needed, early results are promising for promoting healthy eating among Latino families in clinic settings. ^{2 4 6 7 8}

Who Is on the Research Team?

Heather Gibbs, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for Latino parents or guardians over 18 years old with a child aged 1-5. Participants must be the primary food decision-maker, speak English or Spanish, and have internet at home via smartphone or other devices.

Inclusion Criteria

Hispanic/Latino

Owns a device for accessing internet at home

I am over 18 years old.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline

Participating parent and child dyads will undergo procedures and assessments to evaluate nutrition knowledge and eligibility

1 visit

1 visit (in-person)

Nutricity Intervention

Participants will use the Nutricity website to increase nutrition literacy and set nutrition goals via text message

12 weeks

End Study

Participant dyads will perform the same procedures and assessments completed in the baseline visit and complete an exit survey

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for changes in diet quality and other secondary outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Nutricity

Trial Overview The Nutricity program is being tested to see if it can improve children's diet quality when used in pediatric clinics serving Latino families. The study will compare results from families using Nutricity against those on a waitlist.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

12 weeks of mobile intervention (website and text messaging)

Group II: Waitlist Placebo Group 1 Intervention

No intervention for 12 weeks, or until completion of 2nd study visit

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

In a survey of 3,000 consumers, 17% reported experiencing adverse events from health food use, but only 11% of these cases were reported to public health centers, highlighting a significant gap in reporting.

Physicians and pharmacists often do not report adverse events due to health foods because they struggle to establish a clear cause-and-effect relationship, indicating a need for better education on the importance of reporting such incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviors in Response to Adverse Events Associated with Health Food Use: Internet Survey of Consumers, Physicians and Pharmacists. Chiba, T., Kobayashi, E., Sato, Y., et al.[2018]

The increasing use of health foods for disease prevention has raised concerns about potential risks, as many consumers are unaware of the adverse effects that can arise from inappropriate use, such as combining multiple health foods or mixing them with medications.

To address these safety concerns, the Health Foods Network (HFNet) was created as an online database to provide healthcare professionals with evidence-based information on the safety and effectiveness of health foods, aiming to improve patient consultations and promote safe usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Information System on the Safety and Effectiveness of Health Foods and Recent Topics]. Chiba, T.[2019]

The study found that compliance with key nutritional support standards was low, with only 46% adherence to one standard and 82% to another, indicating significant gaps in the management of malnutrition among community-dwelling adults.

Despite high patient satisfaction (86%) with the community prescribing support service, the overall findings suggest a need for quality improvement initiatives to enhance the identification and management of malnutrition, as current practices vary widely among dietitians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research identified variation in nutrition practice by community prescribing dietitians with regards to the identification and management of malnutrition amongst community dwelling adults. Allmark, G., Calder, PC., Marino, LV.[2021]

In a study of hospitalized patients at nutrition risk, combining a protein-enriched menu with individualized dietary counseling led to 92% of patients meeting over 75% of their energy requirements, compared to 76% in the historical intervention group.

The intervention group also showed a significant increase in mean energy and protein intake, with 31 kcal/kg and 1.2 g protein/kg, respectively, indicating that this combined approach is more effective than using a protein-enriched menu alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Evidence to Clinical Practice: Positive Effect of Implementing a Protein-Enriched Hospital Menu in Conjunction With Individualized Dietary Counseling. Munk, T., Bruun, N., Nielsen, MA., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06266468

Nutricity: An mHealth Nutrition Intervention to Improve Diet ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03673267?tab=table

Nutricity: A Pilot Study to Improve Parental Nutrition Literacy The aim of this study is to engage parents and their young children (1-5 years of age) using the mobile intervention, Nutricity. Study goals are to increase ...

3. withpower.com withpower.com/trial/phase-diet-quality-1-2024-693e5

Nutricity for Healthy Eating · Info for Participants In a study of hospitalized patients at nutrition risk, combining a protein-enriched menu with individualized dietary counseling led to 92% of patients meeting ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6305458/

Preliminary Investigation of a Mobile Nutrition Literacy ... “Nutricity” is a novel bilingual (English/Spanish) mobile tool designed by the research team to engage parents and young children to interact with nutrition ...

5. ctv.veeva.com ctv.veeva.com/study/nutricity-an-mhealth-nutrition-intervention-to-improve-diet-quality-among-latino-children

Nutricity: An mHealth Nutrition Intervention to Improve Diet ... The investigators hypothesize the intervention will improve child diet quality and will be feasible for use within the clinic setting. To test ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06266468

Nutricity: An mHealth Nutrition Intervention to Improve Diet ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425003064

Integrating a pilot study and large trial into one adaptive ... The primary objective of the Nutricity study is to test a nutrition intervention aimed at improving diet quality in children, specifically within pediatric ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12134700/

and Web-Based Interventions for Promoting Healthy Diets, ... This systematic review aimed to evaluate the effectiveness of mobile and web-based digital interventions in promoting healthy diets, reducing obesity risk,