What side effects are associated with this type of intervention?

Common treatments for malnutrition, especially those involving digital tools for nutrition education and support, generally focus on improving diet quality and food security. These interventions are typically safe and well-tolerated. However, potential side effects may include initial difficulties in technology adoption, which can lead to frustration or decreased engagement, especially among older adults or those with limited digital literacy. Additionally, there may be a risk of misinformation if the digital tools are not properly monitored or updated. Overall, the benefits of improved nutrition and increased food security usually outweigh these minor challenges.

What prior FDA approvals exist?

The FDA has approved various treatments for malnutrition, primarily focusing on nutritional supplements and medical foods designed to address specific nutrient deficiencies. While there are no direct FDA approvals for digital tools specifically for malnutrition, digital interventions like the Digital Nutrition Intervention study aim to improve food security and diet quality through technology-based education and support. These interventions can complement traditional treatments by providing accessible, personalized nutrition education and support, potentially improving adherence to nutritional guidelines and overall health outcomes.

What other types of research exist?

Promising, novel alternatives to Digital Nutrition Intervention for malnutrition patients in 2024 include: 1) Personalized Nutrition Plans using AI and machine learning to tailor dietary recommendations based on individual health data and genetic profiles. 2) Microbiome-based therapies that focus on gut health to improve nutrient absorption and overall health. 3) Advanced Nutritional Supplements that are specifically formulated to address deficiencies and support recovery in malnourished patients. 4) Telehealth Nutrition Counseling, which provides remote access to dietitians and nutritionists for personalized guidance and support. 5) Community-based Nutrition Programs that integrate local food resources and education to improve dietary habits and access to nutritious foods.

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Digital Nutrition Intervention for Malnutrition

N/A

Waitlist Available

Led By Sarah L Ullevig, PhD

Research Sponsored by The University of Texas at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in loneliness from baseline to 3 and 6 months

Awards & highlights

Study Summary

This trial will test the efficacy of a digital nutrition intervention with at-risk older adults who attend congregate meal centers. The goal is to improve food security and diet quality, and to reduce technology knowledge and usage, physical activity, and social isolation and loneliness.

Who is the study for?

This trial is for older adults aged 60 or above who are facing malnutrition, have a sedentary lifestyle, and feel socially isolated. Participants should lack technology like computers or smartphones, have poor internet access at home, or not know how to use these technologies. They must be able to read and write in English or Spanish and cannot have dementia, Alzheimer's disease, blindness, or any terminal illness.Check my eligibility

What is being tested?

The study tests a digital nutrition intervention aimed at improving food security and diet quality among older adults. It will also assess the impact on their tech knowledge and usage, physical activity levels, as well as feelings of social isolation. The trial uses a stepped-wedge cluster design involving community partners for implementation.See study design

What are the potential side effects?

Since this is a non-medical intervention focusing on technology use for nutrition education rather than drugs or medical treatments, traditional side effects are not expected. However participants may experience frustration with learning new technology.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in loneliness from baseline to 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in loneliness from baseline to 3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in loneliness from baseline to 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diet Quality as measured by the Healthy Eating Index

Secondary outcome measures

Attitudes Towards Technology

Food Security

Loneliness

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 1Experimental Treatment2 Interventions

Cohort 1 will start the intervention directly after randomization.

Group II: Cohort 2Active Control2 Interventions

Cohort 2 will serve as the control while cohort 1 is in the intervention stage. Cohort 2 will start the intervention after cohort 1 concludes the intervention.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Digital tools for treating malnutrition work by providing accessible nutrition education and support, improving food security, and enhancing diet quality. These interventions use technology to deliver personalized dietary guidance, promote healthy eating habits, and offer continuous monitoring and support. This is crucial for malnutrition patients as it helps bridge gaps in access to nutrition information and resources, ensuring they receive consistent and tailored care to improve their nutritional status and overall health.

Find a Location

Who is running the clinical trial?

Older Adult Technology ServicesUNKNOWN

City of San Antonio Department of Human ServicesUNKNOWN

Agile Analytics, LLCUNKNOWN

Media Library

Digital Nutrition Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05220631 — N/A

Malnutrition Research Study Groups: Cohort 2, Cohort 1

Malnutrition Clinical Trial 2023: Digital Nutrition Intervention Highlights & Side Effects. Trial Name: NCT05220631 — N/A

Digital Nutrition Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05220631 — N/A

~41 spots leftby Sep 2024

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