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

NCT03552328 | Completed

• 1 other identifier: Pro00034170
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged; Loneliness; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Revised-UCLA (R-UCLA) Scale

  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.

  Survey will be administered on both study groups twice; once before and once after the six-week period.

Secondary Outcomes (2)

• Patient Health Questionnaire-9 (PHQ-9)

  Survey will be administered on both study groups twice; once before and once after the six-week period.

• Generalized Anxiety Disorder 7-item (GAD-7) Scale

  Survey will be administered on both study groups twice; once before and once after the six-week period.

Study Arms (2)

Intervention

EXPERIMENTAL

Seniors receiving daily meals from Meals on Wheels. Intervention: Lunch with Medical Student.

Other: Lunch with Medical Student

Control

PLACEBO COMPARATOR

Seniors receiving daily meals from Meals on Wheels

Other: Control

Interventions

Lunch with Medical Student OTHER

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.

Intervention

Control OTHER

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.

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of South Florida: lead
• The Arnold P. Gold Foundation: collaborator

Study Sites (1)

Morsani College of Medicine

Tampa, Florida, 33620, United States

Location

Related Publications (12)

• 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.

  BACKGROUND

• Perissinotto CM, Stijacic Cenzer I, Covinsky KE. Loneliness in older persons: a predictor of functional decline and death. Arch Intern Med. 2012 Jul 23;172(14):1078-83. doi: 10.1001/archinternmed.2012.1993.

  PMID: 22710744 BACKGROUND

• Dykstra PA. Older adult loneliness: myths and realities. Eur J Ageing. 2009 Jun;6(2):91-100. doi: 10.1007/s10433-009-0110-3. Epub 2009 Apr 4.

  PMID: 19517025 BACKGROUND

• Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.

  PMID: 18504506 BACKGROUND

• Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.

  PMID: 20668659 BACKGROUND

• 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.

  BACKGROUND

• Steptoe A, Shankar A, Demakakos P, Wardle J. Social isolation, loneliness, and all-cause mortality in older men and women. Proc Natl Acad Sci U S A. 2013 Apr 9;110(15):5797-801. doi: 10.1073/pnas.1219686110. Epub 2013 Mar 25.

  PMID: 23530191 BACKGROUND

• Taube E, Kristensson J, Sandberg M, Midlov P, Jakobsson U. Loneliness and health care consumption among older people. Scand J Caring Sci. 2015 Sep;29(3):435-43. doi: 10.1111/scs.12147. Epub 2014 May 14.

  PMID: 24826811 BACKGROUND

• Gerst-Emerson K, Jayawardhana J. Loneliness as a public health issue: the impact of loneliness on health care utilization among older adults. Am J Public Health. 2015 May;105(5):1013-9. doi: 10.2105/AJPH.2014.302427. Epub 2015 Mar 19.

  PMID: 25790413 BACKGROUND

• MacIntyre I, Corradetti P, Roberts J, Browne G, Watt S, Lane A. Pilot study of a visitor volunteer programme for community elderly people receiving home health care. Health Soc Care Community. 1999 May;7(3):225-232. doi: 10.1046/j.1365-2524.1999.00178.x.

  PMID: 11560637 BACKGROUND

• Wright L, Vance L, Sudduth C, Epps JB. The Impact of a Home-Delivered Meal Program on Nutritional Risk, Dietary Intake, Food Security, Loneliness, and Social Well-Being. J Nutr Gerontol Geriatr. 2015;34(2):218-27. doi: 10.1080/21551197.2015.1022681.

  PMID: 26106989 BACKGROUND

• Cattan M, Kime N, Bagnall AM. The use of telephone befriending in low level support for socially isolated older people--an evaluation. Health Soc Care Community. 2011 Mar;19(2):198-206. doi: 10.1111/j.1365-2524.2010.00967.x. Epub 2010 Nov 29.

  PMID: 21114564 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Lunch

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lucy Guerra, MD, MPH

  Associate Professor, USF College of Medicine Internal Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Student

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 11, 2018
• Study Start: October 15, 2018
• Primary Completion: February 17, 2019
• Study Completion: May 15, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)