MalnutritionVideoDiningNCT04862312
Video Chat During Meals to Improve Nutritional Intake in Older Adults
A study testing VideoDine in people with Malnutrition and Loneliness, run by Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Loneliness
- What is being tested?
- VideoDine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to 17 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receive Meals-on-Wheels meals from Foodnet in Tompkins County, NY.
- Aged 60-95 years old.
- Consume Meals-on-Wheels meal alone.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VideoDining: Using Video Chat to Improve Nutritional Intake in Older Adults
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.
Read the 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.
- Conditions
- Malnutrition, Loneliness
- Being tested
- VideoDine
- Keywords
- Older Adults, Geriatric, Elderly, Malnutrition, Nutrition, Video chat, Loneliness, Social Isolation, Social Facilitation of Eating, Aging in Place, Home Delivered Meals, Technology
- Medical subject headings
- Malnutrition, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoDineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VideoDine | Experimental | Use of video chat to eat a meal with a dining partner. Receives: Behavioral: VideoDine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (8)
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.
Measured: 12 months
Feasibility: Attrition
Percentage of enrolled participants who do not complete the study.
Measured: 12 months
Feasibility: Completion rate
Percentage of participants who complete 6 or more VideoDining sessions in 8 weeks.
Measured: 8 weeks
Feasibility: Technical assistance rate
Number of times participants require assistance to use video chat technology after initial training and set-up.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start31 Mar 2021
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the VideoDining intervention.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Foodnet Meals on Wheels
- Responsible party
- Sponsor
- Investigators
- Laura K Barre, MD, RDN, Principal investigator, Cornell Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862312
- Sponsor's protocol ID
- 2011009963
- Other IDs
- 002254837
- Acronym
- VideoDining
- Status last verified
- Sep 2022
- First submitted
- 29 Mar 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VideoDining: Using Video Chat to Improve Nutritional Intake in Older Adults
- ClinicalTrials.gov ID
- NCT04862312
- Acronym / sponsor ID
- VideoDining / 2011009963
- Conditions
- Malnutrition, Loneliness
- Keywords
- Older Adults, Geriatric, Elderly, Malnutrition, Nutrition, Video chat, Loneliness, Social Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Foodnet Meals on Wheels
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the VideoDining intervention.
| Arm | Type | Receives |
|---|---|---|
| VideoDine | Experimental | Behavioral: VideoDineUse of video chat to eat a meal with a dining partner. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receive Meals-on-Wheels meals from Foodnet in Tompkins County, NY.
- Aged 60-95 years old.
- Consume Meals-on-Wheels meal alone.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideoDineParticipants 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. | Behavioural | VideoDine |
Primary outcome
Change in caloric intake with VideoDining
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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 secondary outcomes
Feasibility: Enrollment rate
Time frame: 12 months
Feasibility: Attrition
Time frame: 12 months
Feasibility: Completion rate
Time frame: 8 weeks
Feasibility: Technical assistance rate
Time frame: 8 weeks
Acceptability: Acceptability of individual VideoDining sessions
Time frame: 8 weeks
Acceptability: Acceptability of VideoDining
Time frame: 8 weeks
VideoDine Self-Efficacy
Time frame: 8 weeks
Social Support
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura K Barre, MD, RDN principal investigator
Cornell Univ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VideoDine in people with Malnutrition and Loneliness, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in caloric intake with VideoDining (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.