Alleviating Loneliness in Older Adults Living in Poverty: A Multi-level Intervention

NCT07123064 | Not Yet Recruiting

• 2 other identifiers: 2023-2024-0624R8002-24
• Study Type: interventional
• Target: 1,344
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to reduce loneliness among Hong Kong Chinese older adults living in poverty with a multi-level intervention involving components at the individual, interpersonal, and community levels.

Conditions

Loneliness; Poverty

Keywords

Loneliness; Poverty; Cluster Randomized Controlled Trials; Older Adults; Mindfulness; SOLUS-D Programme; Group 4 Health; Neighbour Every Day; Hong Kong

Outcome Measures

Primary Outcomes (1)

• UCLA Loneliness Scale

  The 20-item UCLA Loneliness Scale is a reliable self-assessment tool designed to evaluate feelings of loneliness. Each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80.

  Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

Secondary Outcomes (11)

• Pittsburgh Sleep Quality Index

  Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

• Satisfaction with Life Scale

  Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

• De Jong Gierveld Loneliness Scale

  Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

• Lawton Instrumental Activities of Daily Living

  Baseline, 12-month, 24-month

• Activities of Daily Living

  Baseline, 12-month, 24-month

Other Outcomes (8)

• Mindfulness Attention Awareness Scale

  Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

• Self-Compassion Scale

  Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

• Emotion Regulation Questionnaire

  Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

Study Arms (4)

First Arm

EXPERIMENTAL

Individual-level

Behavioral: Individual Level

Second Arm

EXPERIMENTAL

Individual- and Interpersonal-level

Behavioral: Individual Level; Behavioral: Interpersonal Level

Third Arm

EXPERIMENTAL

Individual-, Interpersonal-, and Community-level

Behavioral: Individual Level; Behavioral: Interpersonal Level; Behavioral: Community Level

Forth Arm

ACTIVE COMPARATOR

Education Control Group

Other: Education Control

Interventions

Individual Level BEHAVIORAL

A 8-weekly, 1hour telephone-delivered sessions using mindfulness and SOLUS-D program. Key contents include: introduction to mindfulness - Body awareness and present moment experiences, emotional awareness and mind-body labeling, relaxation techniques and sensory discrimination, deepening awareness and accepting feelings, personal values, interconnection between thought patterns and emotions, identifying and analyzing of thought traps, and challenging thoughts and future planning. Maintenance sessions which focus on embedding mindfulness practices and SOLUS-D program among older adults as a persistent habit will be conducted.

First Arm; Second Arm; Third Arm

Interpersonal Level BEHAVIORAL

A 8 weekly, 1hr sessions through telephone or Zoom using the Group 4 Health. Key contents include: understanding the benefits of social connections, exploring self and community, community and action, support and breakthrough, summary and moving forward. Maintenance sessions which focus on continuous practice of support and community will be conducted.

Second Arm; Third Arm

Community Level BEHAVIORAL

A 4 weekly, 2hour in-person sessions through (1) strengthening collective efficacy via neighbor identification with the community. Key contents include: building neighbourhood connections, getting to know each other, health aging, neighbourhood care, vibrant exploration, thriving community, connecting the dots.

Third Arm

Education Control OTHER

Monthly monthly messages via text, graphics or voice recordings will be sent over a period of 6 months. Key content includes: healthy diet tips, recognizing warning signs of health, understanding dementia, fall prevention tips, health message, and anti-fraud tips.

Forth Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• aged 65 years or older
• living in poverty (defined: inability to afford at least 5 items on the material deprivation index)
• proficiency in spoken Cantonese
• experiencing loneliness (defined: score of ≥ 6 on the 3-item UCLA Loneliness Scale)

You may not qualify if:

• cognitive impairments, psychiatric disorders, learning disabilities, or active suicidal ideation
• actively participating in other psychotherapy or psychosocial interventions in the past 1 year

Sponsors & Collaborators

• The Hong Kong Polytechnic University: collaborator
• Australian National University: collaborator
• The University of Hong Kong: collaborator
• Medical School Berlin: collaborator
• Chinese University of Hong Kong: collaborator
• University of Bern: collaborator
• Linkoeping University: collaborator
• Education University of Hong Kong: lead
• University College, London: collaborator
• University of Texas at Austin: collaborator

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (18)

• Surkalim DL, Luo M, Eres R, Gebel K, van Buskirk J, Bauman A, Ding D. The prevalence of loneliness across 113 countries: systematic review and meta-analysis. BMJ. 2022 Feb 9;376:e067068. doi: 10.1136/bmj-2021-067068.

  PMID: 35140066 BACKGROUND

• Seguin-Fowler RA, Graham ML, Demment M, Uribe ALM, Rethorst CD, Szeszulski J. Multilevel Interventions Targeting Obesity: State of the Science and Future Directions. Annu Rev Nutr. 2024 Aug;44(1):357-381. doi: 10.1146/annurev-nutr-122123-020340. Epub 2024 Aug 12.

  PMID: 38885446 BACKGROUND

• Santini ZI, Koyanagi A, Tyrovolas S, Haro JM, Fiori KL, Uwakwa R, Thiyagarajan JA, Webber M, Prince M, Prina AM. Social network typologies and mortality risk among older people in China, India, and Latin America: A 10/66 Dementia Research Group population-based cohort study. Soc Sci Med. 2015 Dec;147:134-43. doi: 10.1016/j.socscimed.2015.10.061. Epub 2015 Nov 4.

  PMID: 26575604 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

• Masi CM, Chen HY, Hawkley LC, Cacioppo JT. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66. doi: 10.1177/1088868310377394. Epub 2010 Aug 17.

  PMID: 20716644 BACKGROUND

• Lloyd-Evans B, Frerichs J, Stefanidou T, Bone J, Pinfold V, Lewis G, Billings J, Barber N, Chhapia A, Chipp B, Henderson R, Shah P, Shorten A, Giorgalli M, Terhune J, Jones R, Johnson S. The Community Navigator Study: Results from a feasibility randomised controlled trial of a programme to reduce loneliness for people with complex anxiety or depression. PLoS One. 2020 May 29;15(5):e0233535. doi: 10.1371/journal.pone.0233535. eCollection 2020.

  PMID: 32469922 BACKGROUND

• Lengnick-Hall R, Williams NJ, Ehrhart MG, Willging CE, Bunger AC, Beidas RS, Aarons GA. Eight characteristics of rigorous multilevel implementation research: a step-by-step guide. Implement Sci. 2023 Oct 23;18(1):52. doi: 10.1186/s13012-023-01302-2.

  PMID: 37872618 BACKGROUND

• Hunter RF, de la Haye K, Murray JM, Badham J, Valente TW, Clarke M, Kee F. Social network interventions for health behaviours and outcomes: A systematic review and meta-analysis. PLoS Med. 2019 Sep 3;16(9):e1002890. doi: 10.1371/journal.pmed.1002890. eCollection 2019 Sep.

  PMID: 31479454 BACKGROUND

• Hickin N, Kall A, Shafran R, Sutcliffe S, Manzotti G, Langan D. The effectiveness of psychological interventions for loneliness: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Aug;88:102066. doi: 10.1016/j.cpr.2021.102066. Epub 2021 Jul 18.

  PMID: 34339939 BACKGROUND

• Harada K, Masumoto K, Katagiri K, Fukuzawa A, Touyama M, Sonoda D, Chogahara M, Kondo N, Okada S. Three-year effects of neighborhood social network intervention on mental and physical health of older adults. Aging Ment Health. 2021 Dec;25(12):2235-2245. doi: 10.1080/13607863.2020.1839858. Epub 2020 Oct 29.

  PMID: 33118392 BACKGROUND

• Fong P, Cruwys T, Robinson SL, Haslam SA, Haslam C, Mance PL, Fisher CL. Evidence that loneliness can be reduced by a whole-of-community intervention to increase neighbourhood identification. Soc Sci Med. 2021 May;277:113909. doi: 10.1016/j.socscimed.2021.113909. Epub 2021 Apr 6.

  PMID: 33866082 BACKGROUND

• Ernst M, Niederer D, Werner AM, Czaja SJ, Mikton C, Ong AD, Rosen T, Brahler E, Beutel ME. Loneliness before and during the COVID-19 pandemic: A systematic review with meta-analysis. Am Psychol. 2022 Jul-Aug;77(5):660-677. doi: 10.1037/amp0001005. Epub 2022 May 9.

  PMID: 35533109 BACKGROUND

• Cruwys T, Fong P, Evans O, Rathbone JA. A community-led intervention to build neighbourhood identification predicts better wellbeing following prolonged COVID-19 lockdowns. Front Psychol. 2022 Dec 9;13:1030637. doi: 10.3389/fpsyg.2022.1030637. eCollection 2022.

  PMID: 36571042 BACKGROUND

• Creswell JD, Irwin MR, Burklund LJ, Lieberman MD, Arevalo JM, Ma J, Breen EC, Cole SW. Mindfulness-Based Stress Reduction training reduces loneliness and pro-inflammatory gene expression in older adults: a small randomized controlled trial. Brain Behav Immun. 2012 Oct;26(7):1095-101. doi: 10.1016/j.bbi.2012.07.006. Epub 2012 Jul 20.

  PMID: 22820409 BACKGROUND

• Chung GK, Robinson M, Marmot M, Woo J. Monitoring socioeconomic inequalities in health in Hong Kong: insights and lessons from the UK and Australia. Lancet Reg Health West Pac. 2022 Nov 11;31:100636. doi: 10.1016/j.lanwpc.2022.100636. eCollection 2023 Feb.

  PMID: 36879790 BACKGROUND

• Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.

  PMID: 15367063 BACKGROUND

• Agurs-Collins T, Persky S, Paskett ED, Barkin SL, Meissner HI, Nansel TR, Arteaga SS, Zhang X, Das R, Farhat T. Designing and Assessing Multilevel Interventions to Improve Minority Health and Reduce Health Disparities. Am J Public Health. 2019 Jan;109(S1):S86-S93. doi: 10.2105/AJPH.2018.304730.

  PMID: 30699029 BACKGROUND

• Tang VFY, Jiang D, Kwok JYY, Ho HCY, Jian IY, Choi NG, Cruwys T, You JHS, Warner LM, Seewer N, Bai X, Kall A, Andersson G, Krieger T, Lloyd-Evans B, Chou KL. Study Protocol: Connecting older adults through multi-level programmes for alleviating loneliness in Hong Kong older adults (COMPASS-HOA). Front Public Health. 2026 Feb 23;14:1741422. doi: 10.3389/fpubh.2026.1741422. eCollection 2026.

  PMID: 41810289 DERIVED

Study Officials

• Kee Lee Chou, PhD

  The Education University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor of Social Policy

Model Details: Single Blinded, 4-arm cluster randomized controlled trial

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)