- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05220631
Digital Nutrition Intervention for Older Adults
A Technological Intervention to Improve Nutrition Among Older Adult Congregate Meal Participants During COVID-19
The "digital divide" or gap in technological access and knowledge, for older adults has worsened during the COVID-19 pandemic, leading to disruptions in services like congregate meal programs funded by the Older Americans Act. Seven San Antonio congregate meal sites remained partially open biweekly to distribute meals but no longer offer in-person nutrition education, physical activity classes, and social activities. The proposed project will test the efficacy of digital nutrition intervention with at-risk older adults who attend congregate meal center in areas of high poverty and digital exclusion.
The study is uses a stepped-wedge cluster clinical trial. Key community partners with the Department of Health Services Senior Services Division and Older Adult Technology Services (OATS) will participate in the planning phase, research design, and implementation of the study.
The study aims are:
- To test the impact of a technology-based intervention on the primary outcomes of food security and diet quality;
- To determine the effect of the intervention on secondary outcomes of technology knowledge and usage, physical activity, and social isolation and loneliness;
- To examine the long-term impact and sustainability of technology use on food security, diet quality, physical activity, and social isolation.
If successful, the impact of this program could be applied throughout the national OATS network and to similar CMPs to bridge the digital divide beyond the COVID-19 pandemic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project will target community-dwelling older adults who are "congregate meal" program (CMP) participants living in areas at-risk of the digital divide. The CMP is funded by the Older Americans Act and serves over 2000 San Antonio older adults who live 33% below the poverty level and 18% considered at high nutritional risk. During the pandemic, seven San Antonio sites in areas with high poverty and digital exclusion remain partially open biweekly to distribute meals but did not hold in-person nutrition education, physical activity classes, and social activities. The proposed project extends existing congregate meal programming infrastructure and partnerships with Older Adults Technology Services (OATS), a national leader in creating health service programs focusing on older adults. The goal of the proposed study is to remove the digital barrier to receiving essential, evidence-based nutrition programming online, utilizing OATS' five-week technology "Essential Series," which has successfully educated thousands of older adults nationwide by providing support for technology and internet connectivity.
This proposed nutrition intervention will enrolled congregate meal participants using a stepped-wedge cluster design with two cohorts to allow for sequential intervention enrollment with simultaneous control and intervention data collection timepoints. Key community partners within Department of Health Services Senior Services Division and OATS will participate in the planning phase, research design, and implementation of the study. Feedback from congregate meal participants in focus groups will guide the development of the intervention.
The 20-week intervention will include 5 weeks technology training, including internet access and devices, followed by 15 weeks of a culturally tailored nutrition intervention via online sessions. The study will recruit 440 older adult from seven at-risk congregate meal sites. Data will be collected at baseline (T0), during the online intervention (T1), after the online intervention (T2) and 6 months post-intervention (T3).
The successful outcome of our study will be impactful because of the potential broader application of this program throughout the national OATS network and to similar CMPs to bridge the digital divide through and beyond the COVID-19 pandemic.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78249
- University of Texas at San Antonio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 60 years of age
- Inadequate or no working technology device (computer, smart-phone, tablet), no or poor internet connectivity at home, or lack of knowledge and usage of technology
- Food insecurity or low diet quality
Exclusion Criteria:
- Blind
- Terminal disease or illness
- Diagnosis of dementia or Alzheimer's disease
- Unable to read or write in English or Spanish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort 1
Cohort 1 will start the intervention directly after randomization.
|
Older Adult Technology Services (OATS) 5-week technology intervention
15-week nutrition intervention delivered completely online
|
|
Active Comparator: Cohort 2
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.
|
Older Adult Technology Services (OATS) 5-week technology intervention
15-week nutrition intervention delivered completely online
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet Quality as measured by the Healthy Eating Index
Time Frame: Change in diet quality from baseline to 3 and 6 months
|
Two non-consecutive 24-hour dietary recalls will be collected and the Healthy Index will be calculated to determine diet quality.
|
Change in diet quality from baseline to 3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food Security
Time Frame: Change in food security from baseline to 3 and 6 months
|
Food security measured by the USDA's US Adult Food Security Survey Module
|
Change in food security from baseline to 3 and 6 months
|
|
Physical Activity
Time Frame: Change in physical activity from baseline to 3 and 6 months
|
Physical activity measured by the Physical Activity Scale for the Elderly (PASE)
|
Change in physical activity from baseline to 3 and 6 months
|
|
Technology Use and Access
Time Frame: Change in technology use and access from baseline to 3 and 6 months
|
Technology use questionnaire from the National Health & Aging Trends Study
|
Change in technology use and access from baseline to 3 and 6 months
|
|
Attitudes Towards Technology
Time Frame: Change in attitudes towards technology from baseline to 3 and 6 months
|
Adapted from Attitudes Towards Computers Questionnaire (ATCQ)
|
Change in attitudes towards technology from baseline to 3 and 6 months
|
|
Social Isolation
Time Frame: Change in social isolation from baseline to 3 and 6 months
|
Social isolation measured by The Social Disconnectedness Scale and the Perceived Isolation Scale
|
Change in social isolation from baseline to 3 and 6 months
|
|
Loneliness
Time Frame: Change in loneliness from baseline to 3 and 6 months
|
Loneliness assessed by the 3-item UCAL Loneliness Scale
|
Change in loneliness from baseline to 3 and 6 months
|
|
Malnutrition
Time Frame: Change in malnutrition from baseline to 3 and 6 months
|
Malnutrition measured by the Mini Nutrition Assessment Short-Form
|
Change in malnutrition from baseline to 3 and 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sarah L Ullevig, PhD, University of Texas at San Antonio
Publications and helpful links
General Publications
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- Boreskie KF, Hay JL, Duhamel TA. Preventing Frailty Progression during the COVID-19 Pandemic. J Frailty Aging. 2020;9(3):130-131. doi: 10.14283/jfa.2020.29. No abstract available.
- de Faria Coelho-Ravagnani C, Corgosinho FC, Sanches FFZ, Prado CMM, Laviano A, Mota JF. Dietary recommendations during the COVID-19 pandemic. Nutr Rev. 2021 Mar 9;79(4):382-393. doi: 10.1093/nutrit/nuaa067.
- Saffel-Shrier S, Johnson MA, Francis SL. Position of the Academy of Nutrition and Dietetics and the Society for Nutrition Education and Behavior: Food and Nutrition Programs for Community-Residing Older Adults. J Nutr Educ Behav. 2019 Jul-Aug;51(7):781-797. doi: 10.1016/j.jneb.2019.03.007. Epub 2019 May 16.
- Huffman FG, Vaccaro JA, Vieira ER, Zarini GG. Health-Related Characteristics of Older Adults Who Attend Congregate Meal Sites in the United States. Geriatrics (Basel). 2017 Jul 14;2(3):22. doi: 10.3390/geriatrics2030022.
- Sahyoun NR, Pratt CA, Anderson A. Evaluation of nutrition education interventions for older adults: a proposed framework. J Am Diet Assoc. 2004 Jan;104(1):58-69. doi: 10.1016/j.jada.2003.10.013.
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- Neves FJ, Tomita LY, Liu ASLW, Andreoni S, Ramos LR. Educational interventions on nutrition among older adults: A systematic review and meta-analysis of randomized clinical trials. Maturitas. 2020 Jun;136:13-21. doi: 10.1016/j.maturitas.2020.03.003. Epub 2020 Mar 19.
- Brewer D, Dickens E, Humphrey A, Stephenson T. Increased Fruit and Vegetable Intake among Older Adults Participating in Kentucky's Congregate Meal Site Program. Educ Gerontol. 2016;42(11):771-784. doi: 10.1080/03601277.2016.1231511. Epub 2016 Sep 3.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-21-241
- 1R01NR020303-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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