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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04862312
Other study ID # 2011009963
Secondary ID 002254837
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2021
Est. completion date May 17, 2022

Study information

Verified date September 2022
Source Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 response to VideoDining.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date May 17, 2022
Est. primary completion date May 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 95 Years
Eligibility Inclusion Criteria: 1. Receive Meals-on-Wheels meals from Foodnet in Tompkins County, NY. 2. Aged 60-95 years old. 3. Consume Meals-on-Wheels meal alone. Exclusion Criteria: 1. Non-English speaking. 2. Unable to read and write in English. 3. Inadequate vision and hearing to utilize video chat technology. 4. Unable cognitively to independently consent and participate in the study. 5. Already own and use an Amazon Echo Show.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
VideoDine
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.

Locations

Country Name City State
United States Cornell University Ithaca New York

Sponsors (3)

Lead Sponsor Collaborator
Cornell University Foodnet Meals on Wheels, United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Participant Hand Grip Strength 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). Baseline
Other Risk for Sarcopenia 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. Baseline
Other Risk of Malnutrition 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). Baseline
Other Participant Muscle Wasting 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. Baseline
Other Participant Subcutaneous Fat Wasting 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. Baseline
Other Participant Weight 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. Baseline
Other Participant Height Participant height will be measured using the Seca 213 Portable Stadiometer at the participant's home. Baseline
Other Body Mass Index Participant BMI will be calculated as weight in kilograms over height in meters squared using collected weight and height measurements. Baseline
Other Adequacy of Energy Intake 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. Baseline
Other Weight Loss 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). Baseline
Primary 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
Primary 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
Primary 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 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. 12 months
Secondary Feasibility: Attrition Percentage of enrolled participants who do not complete the study. 12 months
Secondary Feasibility: Completion rate Percentage of participants who complete 6 or more VideoDining sessions in 8 weeks. 8 weeks
Secondary Feasibility: Technical assistance rate Number of times participants require assistance to use video chat technology after initial training and set-up. 8 weeks
Secondary 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. 8 weeks
Secondary 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. 8 weeks
Secondary 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. 8 weeks
Secondary 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. 8 weeks
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