Clinical trial NCT05220631: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nutrition Poor
Physical Inactivity
Social Isolation
Keywords: Technology
Older adult
Nutrition
Food security
Physical activity
Social isolation
Lead sponsor: The University of Texas at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Older Adult Technology Services
name: City of San Antonio Department of Human Services
name: Agile Analytics, LLC
First posted: 2022-02-02
Enrollment: 369
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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

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.

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

Primary outcomes:
measure: Diet Quality as measured by the Healthy Eating Index
timeFrame: Change in diet quality from baseline to 3 and 6 months
Secondary outcomes:
measure: Food Security
timeFrame: Change in food security from baseline to 3 and 6 months
measure: Physical Activity
timeFrame: Change in physical activity from baseline to 3 and 6 months
measure: Technology Use and Access
timeFrame: Change in technology use and access from baseline to 3 and 6 months
measure: Attitudes Towards Technology
timeFrame: Change in attitudes towards technology from baseline to 3 and 6 months
measure: Social Isolation
timeFrame: Change in social isolation from baseline to 3 and 6 months
measure: Loneliness
timeFrame: Change in loneliness from baseline to 3 and 6 months
measure: Malnutrition
timeFrame: Change in malnutrition from baseline to 3 and 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas at San Antonio
state: Texas
Study officials:
affiliation: University of Texas at San Antonio
name: Sarah L Ullevig, PhD
role: PRINCIPAL_INVESTIGATOR
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