NCT04862312

Brief Summary

The VideoDining study is a Stage IB behavioral intervention development project. The objectives are to determine the feasibility and acceptability of using video chat during mealtimes (VideoDining) in community-dwelling older adults eating alone at home and to evaluate changes in nutritional intake and loneliness in response to VideoDining.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

March 29, 2021

Last Update Submit

September 23, 2022

Conditions

Keywords

Older AdultsGeriatricElderlyMalnutritionNutritionVideo chatLonelinessSocial IsolationSocial Facilitation of EatingAging in PlaceHome Delivered MealsTechnology

Outcome Measures

Primary Outcomes (3)

  • Change in caloric intake with VideoDining

    A research interviewer will use video chat to collect three 24-hour dietary recalls with each participant prior to starting the VideoDining sessions (pre-VideoDining). During the intervention phase, a research interviewer will use video chat to collect a 24-hour dietary recall after each VideoDining session to capture dietary intake during the VideoDining meal and subsequent day (post-VideoDining). Change in dietary intake will be calculated by comparing average caloric intake on the three pre-VideoDining recalls to the average caloric intake on the final three post-VideoDining recalls.

    8 weeks

  • Change in dietary intake pattern with VideoDining

    A research interviewer will use video chat to collect three 24-hour dietary recalls with each participant prior to starting the VideoDining sessions (pre-VideoDining). During the intervention phase, a research interviewer will use video chat to collect a 24-hour dietary recall after each VideoDining session to capture dietary intake during the VideoDining meal and subsequent day (post-VideoDining). Change in diet quality will be determined by comparing average food group equivalents and the Healthy Eating Index (HEI) on the three pre-VideoDining recalls to the average for the final three post-VideoDining recalls.

    8 weeks

  • Change in loneliness with VideoDining

    The Revised 20-item UCLA Loneliness Scale and the 6-item De Jong Giervald Loneliness Scale will be collected prior to VideoDining and at the end of the study after VideoDining. The Revised 20-item UCLA Loneliness scale measures an individual's subjective feelings of loneliness and social isolation. Each question is scored 1-4, for a total of 20 to 80 points, with 80 indicating more loneliness. The 6-item De Jong Giervald Loneliness Scale uses a 3-item loneliness scale and a 3-item emotional scale. Each item is scored 0, 1 or 2, for a possible total score of 0-6, 0 being least lonely and 6 being most lonely. Total sum scores for each scale will be calculated pre and post VideoDining and compared.

    8 weeks

Secondary Outcomes (8)

  • Feasibility: Enrollment rate

    12 months

  • Feasibility: Attrition

    12 months

  • Feasibility: Completion rate

    8 weeks

  • Feasibility: Technical assistance rate

    8 weeks

  • Acceptability: Acceptability of individual VideoDining sessions

    8 weeks

  • +3 more secondary outcomes

Other Outcomes (10)

  • Participant Hand Grip Strength

    Baseline

  • Risk for Sarcopenia

    Baseline

  • Risk of Malnutrition

    Baseline

  • +7 more other outcomes

Study Arms (1)

VideoDine

EXPERIMENTAL

Use of video chat to eat a meal with a dining partner.

Behavioral: VideoDine

Interventions

VideoDineBEHAVIORAL

Participants will VideoDine with a dining partner at least six times during an eight week period. VideoDining involves sharing a meal with someone not physically present using video chat technology. Dining partners will be recruited, trained and paired with participants. Participants will be provided Amazon Echo Show devices for video chat.

VideoDine

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receive Meals-on-Wheels meals from Foodnet in Tompkins County, NY.
  • Aged 60-95 years old.
  • Consume Meals-on-Wheels meal alone.

You may not qualify if:

  • Non-English speaking.
  • Unable to read and write in English.
  • Inadequate vision and hearing to utilize video chat technology.
  • Unable cognitively to independently consent and participate in the study.
  • Already own and use an Amazon Echo Show.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornell University

Ithaca, New York, 14853, United States

Location

MeSH Terms

Conditions

MalnutritionSocial Isolation

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesSocial BehaviorBehavior

Study Officials

  • Laura K Barre, MD, RDN

    Cornell Univ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All participants will receive the VideoDining intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 27, 2021

Study Start

March 31, 2021

Primary Completion

May 17, 2022

Study Completion

May 17, 2022

Last Updated

September 26, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Deidentified individual participant data that underlie the results will be shared within one year of final data collection and be available for at least 5 years. Data will be available on Open Science Framework. Access to the data will be granted upon request, after verification of the requesting investigator/clinician. Requests should be directed to LKB35@cornell.edu.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will be available within one year of completion of data collection and be available for at least 5 years.
Access Criteria
Available upon request and verification of requesting investigator/clinician.

Locations