NCT05220631

Brief 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. 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:

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
369

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

January 19, 2022

Last Update Submit

December 15, 2025

Conditions

Keywords

TechnologyOlder adultNutritionFood securityPhysical activitySocial isolation

Outcome Measures

Primary Outcomes (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.

    Change in diet quality from baseline to 3 and 6 months

Secondary Outcomes (7)

  • Food Security

    Change in food security from baseline to 3 and 6 months

  • Physical Activity

    Change in physical activity from baseline to 3 and 6 months

  • Technology Use and Access

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

  • Attitudes Towards Technology

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

  • Social Isolation

    Change in social isolation from baseline to 3 and 6 months

  • +2 more secondary outcomes

Study Arms (2)

Cohort 1

EXPERIMENTAL

Cohort 1 will start the intervention directly after randomization.

Behavioral: Technology interventionBehavioral: Digital Nutrition Intervention

Cohort 2

ACTIVE COMPARATOR

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.

Behavioral: Technology interventionBehavioral: Digital Nutrition Intervention

Interventions

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

Cohort 1Cohort 2

15-week nutrition intervention delivered completely online

Cohort 1Cohort 2

Eligibility Criteria

Age60 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at San Antonio

San Antonio, Texas, 78249, United States

Location

Related Publications (48)

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Related Links

MeSH Terms

Conditions

MalnutritionSedentary BehaviorSocial IsolationMotor Activity

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBehaviorSocial Behavior

Study Officials

  • Sarah L Ullevig, PhD

    University of Texas at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 2, 2022

Study Start

June 1, 2022

Primary Completion

September 30, 2024

Study Completion

January 30, 2026

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All IPD collected will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available after primary and secondary outcome measures has been analyzed and published.
Access Criteria
Data will be made available for research educational purposes.

Locations