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Nutrition PoorNCT05220631

Digital Nutrition Intervention for Older Adults

A study testing Technology intervention and Digital Nutrition Intervention in people with Nutrition Poor and Physical Inactivity, run by The University of Texas at San Antonio at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 120 yearsHealthy volunteers can take part
What is being tested?
Technology intervention and Digital Nutrition Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
369 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 30 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Blind
  • Terminal disease or illness
  • Diagnosis of dementia or Alzheimer's disease
  • Unable to read or write in English or Spanish

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas at San Antonio

    San Antonio, Texas, 78249

Other trials in United States

About this study

Official title: 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.

Read more

The study aims are:

  1. To test the impact of a technology-based intervention on the primary outcomes of food security and diet quality;
  2. To determine the effect of the intervention on secondary outcomes of technology knowledge and usage, physical activity, and social isolation and loneliness;
  3. 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

Read the 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.

Being tested
Technology intervention, Digital Nutrition Intervention
Keywords
Technology, Older adult, Nutrition, Food security, Physical activity, Social isolation
Medical subject headings
Malnutrition, Sedentary Behavior, Social Isolation, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technology interventionBehavioural

    Older Adult Technology Services (OATS) 5-week technology intervention

  • Digital Nutrition InterventionBehavioural

    15-week nutrition intervention delivered completely online

Study groups in NCT05220631
Study groupRoleWhat they receive
Cohort 1ExperimentalCohort 1 will start the intervention directly after randomization.
Receives: Behavioral: Technology intervention; Behavioral: Digital Nutrition Intervention
Cohort 2Active comparatorCohort 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.
Receives: Behavioral: Technology intervention; Behavioral: Digital Nutrition Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diet Quality as measured by the Healthy Eating Index

    Two non-consecutive 24-hour dietary recalls will be collected and the Healthy Index will be calculated to determine diet quality.

    Measured: Change in diet quality from baseline to 3 and 6 months

Secondary outcomes (7)
  1. Food Security

    Food security measured by the USDA's US Adult Food Security Survey Module

    Measured: Change in food security from baseline to 3 and 6 months

  2. Physical Activity

    Physical activity measured by the Physical Activity Scale for the Elderly (PASE)

    Measured: Change in physical activity from baseline to 3 and 6 months

  3. Technology Use and Access

    Technology use questionnaire from the National Health \& Aging Trends Study

    Measured: Change in technology use and access from baseline to 3 and 6 months

  4. Attitudes Towards Technology

    Adapted from Attitudes Towards Computers Questionnaire (ATCQ)

    Measured: Change in attitudes towards technology from baseline to 3 and 6 months

  5. Social Isolation

    Social isolation measured by The Social Disconnectedness Scale and the Perceived Isolation Scale

    Measured: Change in social isolation from baseline to 3 and 6 months

  6. Loneliness

    Loneliness assessed by the 3-item UCAL Loneliness Scale

    Measured: Change in loneliness from baseline to 3 and 6 months

  7. Malnutrition

    Malnutrition measured by the Mini Nutrition Assessment Short-Form

    Measured: Change in malnutrition from baseline to 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start1 Jun 2022
  3. Primary completion30 Sep 2024
  4. Study completion30 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Model description
This intervention will use a closed-cohort stepped wedge design. In a stepped wedge design, the timing of the intervention is randomized by cluster, with sequential crossover of clusters from control to intervention until all clusters have received the intervention. With this design, each cluster contributes data when they are participating in the intervention and when they are not. This study will be a two-step stepped wedge design; each of the seven targeted centers will then be randomly assigned to one of two cohorts. Participants in Cohort 1 will receive the intervention first. Six months after baseline data have been collected, Cohort 1 participants will finish the intervention and crossover will occur as Cohort 2 participants begin the intervention. At the 12-month time point, the second cohort will complete the intervention. Data will be collected for both groups in each time period T0-T3.
Masking
None (open label)
Enrolment
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220631
Sponsor's protocol ID
20-21-241
Other IDs
1R01NR020303-01
Status last verified
Dec 2025
First submitted
19 Jan 2022
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD collected will be shared

Publications

  • Butler MJ, Barrientos RM. The impact of nutrition on COVID-19 susceptibility and long-term consequences. Brain Behav Immun. 2020 Jul;87:53-54. doi: 10.1016/j.bbi.2020.04.040. Epub 2020 Apr 18.

    PubMed 32311498
  • Morley JE, Vellas B. Editorial: COVID-19 and Older Adults. J Nutr Health Aging. 2020;24(4):364-365. doi: 10.1007/s12603-020-1349-9. No abstract available.

    PubMed 32242202
  • Brooke J, Jackson D. Older people and COVID-19: Isolation, risk and ageism. J Clin Nurs. 2020 Jul;29(13-14):2044-2046. doi: 10.1111/jocn.15274. Epub 2020 May 5. No abstract available.

    PubMed 32239784
  • Krendl AC, Perry BL. The Impact of Sheltering in Place During the COVID-19 Pandemic on Older Adults' Social and Mental Well-Being. J Gerontol B Psychol Sci Soc Sci. 2021 Jan 18;76(2):e53-e58. doi: 10.1093/geronb/gbaa110.

    PubMed 32778899
  • Morrow-Howell N, Galucia N, Swinford E. Recovering from the COVID-19 Pandemic: A Focus on Older Adults. J Aging Soc Policy. 2020 Jul-Oct;32(4-5):526-535. doi: 10.1080/08959420.2020.1759758. Epub 2020 Apr 26.

    PubMed 32336225
  • Amarantos E, Martinez A, Dwyer J. Nutrition and quality of life in older adults. J Gerontol A Biol Sci Med Sci. 2001 Oct;56 Spec No 2:54-64. doi: 10.1093/gerona/56.suppl_2.54.

    PubMed 11730238
  • Ettman CK, Abdalla SM, Cohen GH, Sampson L, Vivier PM, Galea S. Prevalence of Depression Symptoms in US Adults Before and During the COVID-19 Pandemic. JAMA Netw Open. 2020 Sep 1;3(9):e2019686. doi: 10.1001/jamanetworkopen.2020.19686.

    PubMed 32876685
  • Parlapani E, Holeva V, Nikopoulou VA, Sereslis K, Athanasiadou M, Godosidis A, Stephanou T, Diakogiannis I. Intolerance of Uncertainty and Loneliness in Older Adults During the COVID-19 Pandemic. Front Psychiatry. 2020 Aug 19;11:842. doi: 10.3389/fpsyt.2020.00842. eCollection 2020.

    PubMed 32973584
  • Naja F, Hamadeh R. Nutrition amid the COVID-19 pandemic: a multi-level framework for action. Eur J Clin Nutr. 2020 Aug;74(8):1117-1121. doi: 10.1038/s41430-020-0634-3. Epub 2020 Apr 20. No abstract available.

    PubMed 32313188
  • Topinkova E. Aging, disability and frailty. Ann Nutr Metab. 2008;52 Suppl 1:6-11. doi: 10.1159/000115340. Epub 2008 Mar 7.

    PubMed 18382070
  • Bollwein J, Volkert D, Diekmann R, Kaiser MJ, Uter W, Vidal K, Sieber CC, Bauer JM. Nutritional status according to the mini nutritional assessment (MNA(R)) and frailty in community dwelling older persons: a close relationship. J Nutr Health Aging. 2013 Apr;17(4):351-6. doi: 10.1007/s12603-013-0034-7.

    PubMed 23538658
  • Trevisan C, Crippa A, Ek S, Welmer AK, Sergi G, Maggi S, Manzato E, Bea JW, Cauley JA, Decullier E, Hirani V, LaMonte MJ, Lewis CE, Schott AM, Orsini N, Rizzuto D. Nutritional Status, Body Mass Index, and the Risk of Falls in Community-Dwelling Older Adults: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2019 May;20(5):569-582.e7. doi: 10.1016/j.jamda.2018.10.027. Epub 2018 Dec 13.

    PubMed 30554987
  • Wei K, Nyunt MSZ, Gao Q, Wee SL, Ng TP. Long-term changes in nutritional status are associated with functional and mortality outcomes among community-living older adults. Nutrition. 2019 Oct;66:180-186. doi: 10.1016/j.nut.2019.05.006. Epub 2019 May 29.

    PubMed 31310959
  • Verlaan S, Ligthart-Melis GC, Wijers SLJ, Cederholm T, Maier AB, de van der Schueren MAE. High Prevalence of Physical Frailty Among Community-Dwelling Malnourished Older Adults-A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2017 May 1;18(5):374-382. doi: 10.1016/j.jamda.2016.12.074. Epub 2017 Feb 24.

    PubMed 28238676
  • 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.

    PubMed 32588024

Questions about this trial

What is this clinical trial studying?

A study testing Technology intervention and Digital Nutrition Intervention in people with Nutrition Poor and Physical Inactivity, run by The University of Texas at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diet Quality as measured by the Healthy Eating Index (time frame: Change in diet quality from baseline to 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220631, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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