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Digital Nutrition Intervention for Older Adults

Sponsor
The University of Texas at San Antonio (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05220631
Collaborator
National Institute of Nursing Research (NINR) (NIH), Older Adult Technology Services (Other), City of San Antonio Department of Human Services (Other), Agile Analytics, LLC (Other)
440
Enrollment
1
Location
2
Arms
19
Anticipated Duration (Months)
23.1
Patients Per Site Per Month

Study Details

Study Description

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. 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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Technology intervention
  • Behavioral: Digital Nutrition Intervention
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
440 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention 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.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)
Primary Purpose:
Supportive Care
Official Title:
A Technological Intervention to Improve Nutrition Among Older Adult Congregate Meal Participants During COVID-19
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Cohort 1 will start the intervention directly after randomization.

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

Behavioral: Digital Nutrition 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.

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

Behavioral: Digital Nutrition Intervention
15-week nutrition intervention delivered completely online

Outcome Measures

Primary Outcome Measures

  1. Diet Quality as measured by the Healthy Eating Index [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.

Secondary Outcome Measures

  1. Food Security [Change in food security from baseline to 3 and 6 months]

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

  2. Physical Activity [Change in physical activity from baseline to 3 and 6 months]

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

  3. Technology Use and Access [Change in technology use and access from baseline to 3 and 6 months]

    Technology use questionnaire from the National Health & Aging Trends Study

  4. Attitudes Towards Technology [Change in attitudes towards technology from baseline to 3 and 6 months]

    Adapted from Attitudes Towards Computers Questionnaire (ATCQ)

  5. Social Isolation [Change in social isolation from baseline to 3 and 6 months]

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

  6. Loneliness [Change in loneliness from baseline to 3 and 6 months]

    Loneliness assessed by the 3-item UCAL Loneliness Scale

  7. Malnutrition [Change in malnutrition from baseline to 3 and 6 months]

    Malnutrition measured by the Mini Nutrition Assessment Short-Form

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Texas at San Antonio San Antonio Texas United States 78249

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Sarah L Ullevig, PhD, University of Texas at San Antonio

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Sarah Ullevig, Associate Professor, The University of Texas at San Antonio
ClinicalTrials.gov Identifier:
NCT05220631
Other Study ID Numbers:
  • 20-21-241
  • 1R01NR020303-01
First Posted:
Feb 2, 2022
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sarah Ullevig, Associate Professor, The University of Texas at San Antonio
Technology
Older adult
Nutrition
Food security
Physical activity
Social isolation
Additional relevant MeSH terms:
Malnutrition

Study Results

No Results Posted as of May 13, 2022