Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
369 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-06-01
Study Completion Date
2025-06-30
Brief Summary
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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
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
Detailed Description
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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.
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.
Conditions
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Nutrition Poor
Physical Inactivity
Social Isolation
Keywords
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Technology
Older adult
Nutrition
Food security
Physical activity
Social isolation
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Cohort 1
Cohort 1 will start the intervention directly after randomization.
Group Type
EXPERIMENTAL
Technology intervention
Intervention Type
BEHAVIORAL
Older Adult Technology Services (OATS) 5-week technology intervention
Digital Nutrition Intervention
Intervention Type
BEHAVIORAL
15-week nutrition intervention delivered completely online
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.
Group Type
ACTIVE_COMPARATOR
Technology intervention
Intervention Type
BEHAVIORAL
Older Adult Technology Services (OATS) 5-week technology intervention
Digital Nutrition Intervention
Intervention Type
BEHAVIORAL
15-week nutrition intervention delivered completely online
Interventions
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Technology intervention
Older Adult Technology Services (OATS) 5-week technology intervention
Intervention Type
BEHAVIORAL
Digital Nutrition Intervention
15-week nutrition intervention delivered completely online
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* Terminal disease or illness
* Diagnosis of dementia or Alzheimer's disease
* Unable to read or write in English or Spanish
Minimum Eligible Age
60 Years
Maximum Eligible Age
120 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Sponsor Role
collaborator
Older Adult Technology Services
UNKNOWN
Sponsor Role
collaborator
City of San Antonio Department of Human Services
UNKNOWN
Sponsor Role
collaborator
Agile Analytics, LLC
UNKNOWN
Sponsor Role
collaborator
The University of Texas at San Antonio
OTHER
Sponsor Role
lead
Responsible Party
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Sarah Ullevig
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Sarah L Ullevig, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas at San Antonio
Locations
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University of Texas at San Antonio
San Antonio, Texas, United States
Site Status
Countries
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United States
References
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Related Links
Access external resources that provide additional context or updates about the study.
http://www.sanantonio.gov/Portals/0/Files/HumanServices/FaithBased/2019PovertyReport.pdf
Status of Poverty in San Antonio 2019
http://www.aarp.org/content/dam/aarp/aarp_foundation/2015-PDFs/AF-Food-Insecurity-2015Update-Final-Report.pdf
Food Insecurity Among Older Adults
http://www.ncoa.org/article/7-facts-about-older-adults-and-snap
7 Facts about Older Adults and SNAP. National Council on Aging.
Other Identifiers
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20-21-241
Identifier Type: -
Identifier Source: org_study_id