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Trial record 3 of 6 for:    Not yet recruiting Studies | Loneliness

Effects of a Volunteer-based Lunch Program on Feelings of Loneliness in Elders

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ClinicalTrials.gov Identifier: NCT03552328
Recruitment Status : Not yet recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
The Arnold P. Gold Foundation
Information provided by (Responsible Party):
Brennan Ninesling, University of South Florida

Brief Summary:

Background: There is a need for stronger community involvement with the elderly, specifically those with feelings of loneliness. Large proportions of elders in previous studies reported feelings of loneliness, and loneliness at advanced ages is a growing trend seen within the last thirty years despite advances in technology and social media. We propose a randomized control trial to determine the effectiveness of a volunteer-based lunch program on decreasing feelings of loneliness in elderly participants.

Methods: Lonely elders in the community will be identified and matched with a trained medical student. Each student will bring provided lunches once a week to their elder participant's residence, and they will share lunch together for an hour once a week for six weeks. Enrollees are eligible for the study if they are over 60 years of age, speak English, have feelings of loneliness on the three-item scale, and display no cognitive impairment. The participants will be assessed pre and post intervention using the R-UCLA scale for loneliness, PHQ-9 for depressive symptoms, and GAD-7 for feelings of anxiety. Participant satisfaction will be assessed using Likert items as well as open-ended questions. Intervention group responses will be compared to responses of participants that did not receive the lunch meeting intervention.

Discussion: Success of such a companion lunch program would provide an effective route to combat loneliness in the elderly.


Condition or disease Intervention/treatment Phase
Aged Loneliness Depression Anxiety Other: Lunch with Medical Student Other: Control Not Applicable

Detailed Description:

Since the 1960's, the elderly population in the United States has grown steadily. By 2030, one in three people in the U.S. will be over the age of 65. In addition to being at a greater risk for chronic disease, the elderly are also more vulnerable to being socially isolated and lonely. Simply living alone does not appear to be a significant predictor of loneliness, as the elderly could still have a strong support network while living alone, but prevalence data suggests that one in three adults over the age of 65 are lonely. Furthermore, the oldest of the elderly seem to be the loneliest. Dykstra et al. in a 2009 study estimate 40 to 50 percent of those aged 80 or older to be lonely.

Loneliness has been previously defined as the difference between desired and actual relationships, and there is a distinction between loneliness and social isolation. While being considered socially isolated is due to lack of social contact, loneliness is assessed by perceptions of social isolation. Feelings of disconnect, isolation, and not belonging are much more indicative of loneliness than simple aloneness and lack of social contact. Not having a support network or anyone to confide in can lead to feelings of social isolation, and despite advances in technology and the development of social media, feelings of loneliness have increased in the past thirty years. The proportion of Americans who said they had no one to talk to about important matters increased from 10% in 1985 to 25% in 2004. This is an alarming trend because social support has been consistently shown to increase the likelihood of survival. In a meta-analytic review from 2009, participants with strong social relationships and support were found to have a 50 percent increased likelihood of survival. Additionally, a 2013 study found that mortality rates were significantly higher among socially isolated and lonely elders. Loneliness has a profound effect on our healthcare system and has been linked to a higher degree of healthcare utilization. In a Swedish study from 2014, researchers found that lonely elders use more outpatient services than non-lonely elders. In 2015, Gerst et al. found that the large proportion of elders over 60 years old that reported feelings of loneliness had a significantly higher physician visit rate.

There is a demonstrated need for intervention in this lonely, elderly population, with significant public health implications. A randomized control trial from 1999 implementing a visitor volunteer program for the elderly showed that strong community involvement increased the participants' feelings of worth, social integration, and life satisfaction. More recently, a local food delivery project in Tampa showed that weekly food delivery to an at-risk elderly population decreased participants' feelings of loneliness and increased their measured well-being over the course of two months. While both pilot programs had short evaluation periods, they demonstrated the effectiveness of volunteer-based community involvement. Combining a visitor volunteer program with a food delivery service could serve to effectively combat the elderly community's feelings of loneliness and social isolation.

A local food delivery project in Tampa showed that weekly food delivery to an at-risk elderly population decreased participants' feelings of loneliness and increased their measured well-being over the course of two months. Even though it demonstrated the effectiveness of volunteer-based community involvement, the project was constructed as a pretest-posttest, descriptive study using convenience sampling, and feelings of loneliness were evaluated as a secondary objective using a three-item loneliness screener. In our study, we plan to measure the effects of adding a volunteer visitor to the lunch program; that is, to see if eating meals with a medical student can decrease feelings of loneliness when compared with simply receiving meals through Meals on Wheels. Our study is designed as a randomized control trial in which seniors will be randomly assigned to two groups: paired with a medical student for lunch or not paired with a medical student while still receiving meals.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible and consenting participants are randomized to one of the two study groups in a 1:1 allocation ratio. A block-stratified method using the computer will be used for generation of randomization sequence. The block size will be random.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

The randomization sequence will be implemented centrally with one of the co-investigator (Ambuj Kumar) who is off site will retain the list. Once a participant is identified the primary investigator will call the off-site co-investigator for assignment. Given that the co-investigator is not on site will ensure adequate allocation concealment.

Also, since the outcome data will be collected using a questionnaire, the possibility of interpretation does not exist. Data analysts will not be informed of the subject assignment and the coding for participant will be as group 1 or 2.

Primary Purpose: Treatment
Official Title: Effects of a Pilot Volunteer-based Lunch Program on Feelings of Loneliness in Elders: a Randomized Control Trial
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Intervention
Seniors receiving daily meals from Meals on Wheels. Intervention: Lunch with Medical Student.
Other: Lunch with Medical Student
Each student will bring provided lunches once a week to their elder participant's residence, and they will share lunch together for an hour once a week for six weeks. Students will enroll as Meals on Wheels volunteers and participate in the Meals on Wheels pre-program training. On the day of their scheduled lunch, students will first arrive at the Meals on Wheels designated meal-drop location and pick up two lunches, one for them and one for their assigned elder. They will then drive to their assigned elder's residence and eat lunch with them for one hour.

Placebo Comparator: Control
Seniors receiving daily meals from Meals on Wheels
Other: Control
Students will not bring provided lunches to an elder participant's residence. The elder participants in this arm will simply continue receiving daily meals from Meals on Wheels with no accompanying student.




Primary Outcome Measures :
  1. Revised-UCLA (R-UCLA) Scale [ Time Frame: Survey will be administered on both study groups twice; once before and once after the six-week period. ]
    Investigators will measure change from baseline feelings of loneliness in elderly participants. Responses are scored from 20 (minimum) to 80 (maximum). Only total scores are reported. Lower values represent a better outcome, i.e. less feelings of loneliness.


Secondary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Survey will be administered on both study groups twice; once before and once after the six-week period. ]
    We will measure change from baseline feelings of depression in elderly participants. Responses are scored from 0 (minimum) to 27 (maximum). Only total scores are reported. Lower values represent a better outcome, i.e. less feelings of depression.

  2. Generalized Anxiety Disorder 7-item (GAD-7) Scale [ Time Frame: Survey will be administered on both study groups twice; once before and once after the six-week period. ]
    We will measure change from baseline feelings of anxiety in elderly participants. Responses are scored from 0 (minimum) to 21 (maximum). Only total scores are reported. Lower values represent a better outcome, i.e. less feelings of anxiety.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrollees are eligible for the study if they speak English, have feelings of loneliness on the three-item scale, are able to give written consent, and answer surveys.

Exclusion Criteria:

  • Elders who are unable to give informed consent or complete trial documentation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552328


Contacts
Contact: Brennan Ninesling, BS 6788962728 bninesling@health.usf.edu
Contact: Ambuj Kumar, MD, MPH (813) 396-9194 akumar1@health.usf.edu

Sponsors and Collaborators
University of South Florida
The Arnold P. Gold Foundation
Investigators
Study Director: Lucy Guerra, MD, MPH Associate Professor, USF College of Medicine Internal Medicine
  Study Documents (Full-Text)

Documents provided by Brennan Ninesling, University of South Florida:
Study Protocol  [PDF] May 26, 2018
Informed Consent Form  [PDF] March 14, 2018


Publications:
Lawson, V. and K. Kinsella, Aging in the United States: Past, present, and future. 1996, International Programs Center, Population Division, US Bureau of the Census, Washington, DC.
McPherson, M., L. Smith-Lovin, and M.E. Brashears, Social isolation in America: Changes in core discussion networks over two decades. American sociological review, 2006. 71(3): p. 353-375.

Responsible Party: Brennan Ninesling, Medical Student, University of South Florida
ClinicalTrials.gov Identifier: NCT03552328     History of Changes
Other Study ID Numbers: Pro00034170
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will ensure that all data collected during the trial is handled confidentially and accessed only by members of the team. We will store participants' details on a secure database. We will assign participants an individual specific trial number and we will anonymize their details.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No