Video Chat During Meals to Improve Nutritional Intake in Older Adults (VideoDining)
Primary Purpose
Malnutrition, Loneliness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VideoDine
Sponsored by
About this trial
This is an interventional other trial for Malnutrition focused on measuring Older Adults, Geriatric, Elderly, Malnutrition, Nutrition, Video chat, Loneliness, Social Isolation, Social Facilitation of Eating, Aging in Place, Home Delivered Meals, Technology
Eligibility Criteria
Inclusion Criteria:
- Receive Meals-on-Wheels meals from Foodnet in Tompkins County, NY.
- Aged 60-95 years old.
- Consume Meals-on-Wheels meal alone.
Exclusion Criteria:
- 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.
Sites / Locations
- Cornell University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VideoDine
Arm Description
Use of video chat to eat a meal with a dining partner.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Feasibility: Enrollment rate
Number of people enrolled in the study as a percentage of people approached or who showed interest in the study during the recruitment time period.
Feasibility: Attrition
Percentage of enrolled participants who do not complete the study.
Feasibility: Completion rate
Percentage of participants who complete 6 or more VideoDining sessions in 8 weeks.
Feasibility: Technical assistance rate
Number of times participants require assistance to use video chat technology after initial training and set-up.
Acceptability: Acceptability of individual VideoDining sessions
Quantitative data from participant and dining-partner survey responses to questions on enjoyment, comfort, nervousness, technical issues, ease, and experience of VideoDining collected after each VideoDining session.
Acceptability: Acceptability of VideoDining
Qualitative data from end-of-study participant interviews and dining-partner focus groups. Participant responses to open ended questions about overall experience of VideoDining, use of videochat technology, and likes and dislikes of VideoDining will be coded and analyzed.
VideoDine Self-Efficacy
Participant responses to a single item survey question after each VideoDining session. Participant responses to survey questions about confidence level to perform the tasks of VideoDining, collected at the end of the study.
Social Support
Responses to the four questions on the Social Interaction Subscale of the Duke Social Support Index and one question about social interaction with friends and family using videochat will be collected prior to VideoDining and at the end of the study after VideoDining. The results will be compared pre and post VideoDining.
Full Information
NCT ID
NCT04862312
First Posted
March 29, 2021
Last Updated
September 23, 2022
Sponsor
Cornell University
Collaborators
United States Department of Agriculture (USDA), Foodnet Meals on Wheels
1. Study Identification
Unique Protocol Identification Number
NCT04862312
Brief Title
Video Chat During Meals to Improve Nutritional Intake in Older Adults
Acronym
VideoDining
Official Title
VideoDining: Using Video Chat to Improve Nutritional Intake in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
May 17, 2022 (Actual)
Study Completion Date
May 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
Collaborators
United States Department of Agriculture (USDA), Foodnet Meals on Wheels
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The U.S. population is growing older and more adults are aging at home alone, by choice, or due to a lack of affordable senior housing. Older adults who live alone have a less healthy eating pattern, eat a smaller variety of foods and consume fewer fruits and vegetables than those living with others. Additionally, eating alone, social isolation and loneliness often accompany living alone and are independent risk factors for lower caloric intake, less variety in the diet and malnutrition. Community-based interventions are needed to improve the nutritional status of older adults living alone.
VideoDining uses video chat during mealtimes to virtually eat with another person and could provide social interactions and modeling to improve dietary intake in older adults eating alone. Extensive observational and experimental research shows that people eat more when dining with others than dining alone, called the social facilitation of eating. Additionally, a dining partner's modeling of eating can provide a guide for what and how much to eat. The investigators have conducted a Stage IA proof-of-concept study of VideoDining in older adults and will expand the development of this behavioral intervention with this study.
The goals are to determine the feasibility and acceptability of VideoDining and to evaluate changes in nutritional intake and loneliness in response to multiple VideoDining sessions in community-dwelling older adults eating alone at home. In this single-arm intervention study, thirty older adult Meals on Wheels participants will be scheduled to VideoDine with a dining partner six times. Using a mixed-methods approach, the investigators will collect data on older adults' ability to VideoDine, acceptance of VideoDining, dietary intake, and loneliness. Data will be collected before starting VideoDining, after each VideoDining session, and at the end of the study period. Development, adaptation and refinement of the VideoDining intervention are additional key outcomes of this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Loneliness
Keywords
Older Adults, Geriatric, Elderly, Malnutrition, Nutrition, Video chat, Loneliness, Social Isolation, Social Facilitation of Eating, Aging in Place, Home Delivered Meals, Technology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive the VideoDining intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VideoDine
Arm Type
Experimental
Arm Description
Use of video chat to eat a meal with a dining partner.
Intervention Type
Behavioral
Intervention Name(s)
VideoDine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in caloric intake with VideoDining
Description
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.
Time Frame
8 weeks
Title
Change in dietary intake pattern with VideoDining
Description
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.
Time Frame
8 weeks
Title
Change in loneliness with VideoDining
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Feasibility: Enrollment rate
Description
Number of people enrolled in the study as a percentage of people approached or who showed interest in the study during the recruitment time period.
Time Frame
12 months
Title
Feasibility: Attrition
Description
Percentage of enrolled participants who do not complete the study.
Time Frame
12 months
Title
Feasibility: Completion rate
Description
Percentage of participants who complete 6 or more VideoDining sessions in 8 weeks.
Time Frame
8 weeks
Title
Feasibility: Technical assistance rate
Description
Number of times participants require assistance to use video chat technology after initial training and set-up.
Time Frame
8 weeks
Title
Acceptability: Acceptability of individual VideoDining sessions
Description
Quantitative data from participant and dining-partner survey responses to questions on enjoyment, comfort, nervousness, technical issues, ease, and experience of VideoDining collected after each VideoDining session.
Time Frame
8 weeks
Title
Acceptability: Acceptability of VideoDining
Description
Qualitative data from end-of-study participant interviews and dining-partner focus groups. Participant responses to open ended questions about overall experience of VideoDining, use of videochat technology, and likes and dislikes of VideoDining will be coded and analyzed.
Time Frame
8 weeks
Title
VideoDine Self-Efficacy
Description
Participant responses to a single item survey question after each VideoDining session. Participant responses to survey questions about confidence level to perform the tasks of VideoDining, collected at the end of the study.
Time Frame
8 weeks
Title
Social Support
Description
Responses to the four questions on the Social Interaction Subscale of the Duke Social Support Index and one question about social interaction with friends and family using videochat will be collected prior to VideoDining and at the end of the study after VideoDining. The results will be compared pre and post VideoDining.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Participant Hand Grip Strength
Description
A nutrition professional will measure participant hand grip strength using the Jamar Hydraulic Hand Dynamometer at the participant's home. Measurements will be categorized using hand-grip strength cut-points for muscle weakness by gender and age (J Am Geriatr Soc. 2020 Jul;68(7):1429-1437.) and cut-points for likelihood of mobility limitation (J Am Geriatr Soc. 2010 Sep;58(9):1721-6).
Time Frame
Baseline
Title
Risk for Sarcopenia
Description
A nutrition professional will administer the Strength, Assistance with Walking, Rising from a Chair, Climbing Stairs and Falls (SAR-F) survey. Outcomes of the SARC-F will be combined with calf circumference measured in question R (Calf Circumference in cm) of the MNA-FF to complete the SAR-CalF. A total sum score will be calculated, and participants categorized as at risk for sarcopenic (score 11-20) or non-sarcopenic (score 0-10). Results of the SAR-CalF will be combined with hand grip strength data and participant age and BMI to determine overall sarcopenia risk.
Time Frame
Baseline
Title
Risk of Malnutrition
Description
A nutrition professional will administer the Mini Nutritional Assessment Full Form (MNA-FF). A total sum score will be calculated and categorized as Normal nutritional status (24-30 points), At risk of Malnutrition (17-23.5 points) and Malnourished (less than 17 points).
Time Frame
Baseline
Title
Participant Muscle Wasting
Description
A trained nutrition professional will assess temporal, clavicular, calf and interosseous muscle wasting following the Academy of Nutrition and Dietetics Nutrition Focused Physical Exam guidelines. Muscle mass will be categorized at each site as: adequate (no wasting noted), mild, moderate or severe wasting.
Time Frame
Baseline
Title
Participant Subcutaneous Fat Wasting
Description
A trained nutrition professional will assess orbital and triceps subcutaneous fat wasting following the Academy of Nutrition and Dietetics Nutrition Focused Physical Exam guidelines. Subcutaneous fat will be categorized at each site as: adequate (no wasting noted), mild, moderate or severe wasting.
Time Frame
Baseline
Title
Participant Weight
Description
Participant weight will be measured using the Seca 869 Portable Scale. The participant will be weighed in their home while wearing light clothing and no shoes.
Time Frame
Baseline
Title
Participant Height
Description
Participant height will be measured using the Seca 213 Portable Stadiometer at the participant's home.
Time Frame
Baseline
Title
Body Mass Index
Description
Participant BMI will be calculated as weight in kilograms over height in meters squared using collected weight and height measurements.
Time Frame
Baseline
Title
Adequacy of Energy Intake
Description
Participant energy needs will be calculated using the Mifflin St. Jeor formula using the collected height, weight and age data. Participant's average daily calorie intake will be determined from the three baseline 24-hour food recalls entered into ASA24. Adequacy of energy intake will be represented as a percentage of participant calculated intake out of calculated total estimated needs.
Time Frame
Baseline
Title
Weight Loss
Description
Participant weight loss over the last 3 months will be assessed by the MNA-FF survey Question B (weight loss over the last 3 months).
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Receive Meals-on-Wheels meals from Foodnet in Tompkins County, NY.
Aged 60-95 years old.
Consume Meals-on-Wheels meal alone.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura K Barre, MD, RDN
Organizational Affiliation
Cornell Univ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornell University
City
Ithaca
State/Province
New York
ZIP/Postal Code
14853
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will be available within one year of completion of data collection and be available for at least 5 years.
IPD Sharing Access Criteria
Available upon request and verification of requesting investigator/clinician.
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Video Chat During Meals to Improve Nutritional Intake in Older Adults
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