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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05220631
Other study ID # 20-21-241
Secondary ID 1R01NR020303-01
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date June 30, 2025

Study information

Verified date May 2024
Source The University of Texas at San Antonio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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. 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 369
Est. completion date June 30, 2025
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 120 Years
Eligibility 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 Design


Intervention

Behavioral:
Technology intervention
Older Adult Technology Services (OATS) 5-week technology intervention
Digital Nutrition Intervention
15-week nutrition intervention delivered completely online

Locations

Country Name City State
United States University of Texas at San Antonio San Antonio Texas

Sponsors (5)

Lead Sponsor Collaborator
The University of Texas at San Antonio Agile Analytics, LLC, City of San Antonio Department of Human Services, National Institute of Nursing Research (NINR), Older Adult Technology Services

Country where clinical trial is conducted

United States, 

References & Publications (48)

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* Note: There are 48 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Food Security Food security measured by the USDA's US Adult Food Security Survey Module Change in food security from baseline to 3 and 6 months
Secondary Physical Activity Physical activity measured by the Physical Activity Scale for the Elderly (PASE) Change in physical activity from baseline to 3 and 6 months
Secondary Technology Use and Access Technology use questionnaire from the National Health & Aging Trends Study Change in technology use and access from baseline to 3 and 6 months
Secondary Attitudes Towards Technology Adapted from Attitudes Towards Computers Questionnaire (ATCQ) Change in attitudes towards technology from baseline to 3 and 6 months
Secondary Social Isolation Social isolation measured by The Social Disconnectedness Scale and the Perceived Isolation Scale Change in social isolation from baseline to 3 and 6 months
Secondary Loneliness Loneliness assessed by the 3-item UCAL Loneliness Scale Change in loneliness from baseline to 3 and 6 months
Secondary Malnutrition Malnutrition measured by the Mini Nutrition Assessment Short-Form Change in malnutrition from baseline to 3 and 6 months
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