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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Nutricity for healthy eating?

The research suggests that nutrition care, including individualized dietary counseling and protein-enriched menus, can improve dietary behaviors and nutritional intake, which may support the effectiveness of treatments like Nutricity aimed at promoting healthy eating. ^{1 2 3 4 5}

Is Nutricity generally safe for human use?

While some health foods and nutraceuticals are safe, others can have adverse effects, especially if used improperly or with other medications. It's important to have reliable safety information and consult healthcare professionals to ensure safe use. ^{6 7 8 9 10}

How does the treatment Nutricity differ from other treatments for healthy eating?

Nutricity is unique because it focuses on the concept of food synergy, which emphasizes the combined effect of various food components working together, rather than isolated nutrients. This approach aligns with sustainable healthy diets that promote individual health and well-being while being environmentally friendly and culturally acceptable. ^{11 12 13 14 15}

Research Team

Heather Gibbs, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Patient-centred dietetic care from the perspectives of older malnourished patients. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effect of nutrition care provided by primary health professionals on adults' dietary behaviours: a systematic review. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Evidence-based practice strategy: increasing timely nutrition in mechanically ventilated trauma surgical patients. [2011]

4. United States 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. [2021]

5. United States 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. [2018]

6. Japan pubmed.ncbi.nlm.nih.gov

Behaviors in Response to Adverse Events Associated with Health Food Use: Internet Survey of Consumers, Physicians and Pharmacists. [2018]

7. Japan pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Toxicity Potential of Nutraceuticals. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Scientific and regulatory aspects of nutraceutical products in the United States. [2015]

10. Japan pubmed.ncbi.nlm.nih.gov

[Evaluation of Safety Information of the Foods with Function Claims Based on Adverse Event Reports in Information System on Safety and Effectiveness for Health Foods Database]. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Position of the academy of nutrition and dietetics: nutrition security in developing nations: sustainable food, water, and health. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Food synergy: the key to a healthy diet. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Interrelationships of food, nutrition, diet and health: the National Association of State Universities and Land Grant Colleges White Paper. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Shaping Physical, Economic, and Policy Components of the Food Environment to Create Sustainable Healthy Diets. [2021]

15. Chile pubmed.ncbi.nlm.nih.gov

Healthy sustainable food patterns and systems: a planetary urgency. [2021]