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Digital Nutrition Intervention for Older Adults

Primary Purpose

Nutrition Poor, Physical Inactivity, Social Isolation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technology intervention
Digital Nutrition Intervention
Sponsored by
The University of Texas at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Poor focused on measuring Technology, Older adult, Nutrition, Food security, Physical activity, Social isolation

Eligibility Criteria

60 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cohort 1

Cohort 2

Arm Description

Cohort 1 will start the intervention directly after randomization.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Food Security
Food security measured by the USDA's US Adult Food Security Survey Module
Physical Activity
Physical activity measured by the Physical Activity Scale for the Elderly (PASE)
Technology Use and Access
Technology use questionnaire from the National Health & Aging Trends Study
Attitudes Towards Technology
Adapted from Attitudes Towards Computers Questionnaire (ATCQ)
Social Isolation
Social isolation measured by The Social Disconnectedness Scale and the Perceived Isolation Scale
Loneliness
Loneliness assessed by the 3-item UCAL Loneliness Scale
Malnutrition
Malnutrition measured by the Mini Nutrition Assessment Short-Form

Full Information

First Posted
January 19, 2022
Last Updated
June 20, 2023
Sponsor
The University of Texas at San Antonio
Collaborators
National Institute of Nursing Research (NINR), Older Adult Technology Services, City of San Antonio Department of Human Services, Agile Analytics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05220631
Brief Title
Digital Nutrition Intervention for Older Adults
Official Title
A Technological Intervention to Improve Nutrition Among Older Adult Congregate Meal Participants During COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at San Antonio
Collaborators
National Institute of Nursing Research (NINR), Older Adult Technology Services, City of San Antonio Department of Human Services, Agile Analytics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Poor, Physical Inactivity, Social Isolation
Keywords
Technology, Older adult, Nutrition, Food security, Physical activity, Social isolation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
369 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Cohort 1 will start the intervention directly after randomization.
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Technology intervention
Intervention Description
Older Adult Technology Services (OATS) 5-week technology intervention
Intervention Type
Behavioral
Intervention Name(s)
Digital Nutrition Intervention
Intervention Description
15-week nutrition intervention delivered completely online
Primary Outcome Measure Information:
Title
Diet Quality as measured by the Healthy Eating Index
Description
Two non-consecutive 24-hour dietary recalls will be collected and the Healthy Index will be calculated to determine diet quality.
Time Frame
Change in diet quality from baseline to 3 and 6 months
Secondary Outcome Measure Information:
Title
Food Security
Description
Food security measured by the USDA's US Adult Food Security Survey Module
Time Frame
Change in food security from baseline to 3 and 6 months
Title
Physical Activity
Description
Physical activity measured by the Physical Activity Scale for the Elderly (PASE)
Time Frame
Change in physical activity from baseline to 3 and 6 months
Title
Technology Use and Access
Description
Technology use questionnaire from the National Health & Aging Trends Study
Time Frame
Change in technology use and access from baseline to 3 and 6 months
Title
Attitudes Towards Technology
Description
Adapted from Attitudes Towards Computers Questionnaire (ATCQ)
Time Frame
Change in attitudes towards technology from baseline to 3 and 6 months
Title
Social Isolation
Description
Social isolation measured by The Social Disconnectedness Scale and the Perceived Isolation Scale
Time Frame
Change in social isolation from baseline to 3 and 6 months
Title
Loneliness
Description
Loneliness assessed by the 3-item UCAL Loneliness Scale
Time Frame
Change in loneliness from baseline to 3 and 6 months
Title
Malnutrition
Description
Malnutrition measured by the Mini Nutrition Assessment Short-Form
Time Frame
Change in malnutrition from baseline to 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah L Ullevig, PhD
Organizational Affiliation
University of Texas at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD collected will be shared
IPD Sharing Time Frame
Data will become available after primary and secondary outcome measures has been analyzed and published.
IPD Sharing Access Criteria
Data will be made available for research educational purposes.
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Description
7 Facts about Older Adults and SNAP. National Council on Aging.

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Digital Nutrition Intervention for Older Adults

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