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Ameliorating Social Isolation: Identifying Factors That Impede or Facilitate Health-related Social Behavior Change
The Keep Social randomized control trial (RCT) is a 6-week, online study which will test whether, relative to a placebo control condition, an intervention that encourages high-quality in-person social interactions with strangers and acquaintances reduces young adults' (ages 18 - 29) social isolation and loneliness. Participants will complete our 6-week protocol, which includes 6 weeks of passive ecological behavior sampling (i.e., geotracking) and Day Reports, our 4-week Invibe social media messages, plus recurrent Biweekly Assessments (BW1-BW4) that include both self-reported and behavioral measures. The first Monday following enrollment, participants complete the BW1 baseline survey to assess demographic characteristics and initial levels of all outcome variables (primary and secondary, \~20 min). They also (optionally) activate passive geotracking on this day and leave it activated, continuously, for the duration of the study. During the 2-week baseline and 4-week Invibe phases, time-varying psychological and behavioral mediators and moderators will be assessed three times per week via Day Reports. To increase ecological validity, each week, two weekdays (i.e., Monday, Tuesday, Wednesday, or Thursday), and one weekend day (i.e., Friday, Saturday or Sunday) will be randomly selected. Day reports will not be assigned on Mondays if there is a biweekly assessment scheduled.
Social isolation and its subjective counterpart loneliness-well established as risk factors for poor physical and mental health-have been rising at alarming rates in the US, especially among young adults. Mechanistic understanding of how best to build social connectedness to ameliorate social isolation is sorely needed to redirect life trajectories toward health and well-being. In creating this foundational knowledge, variations across individuals and geographic location merit focus because these variations may be associated with unique challenges and opportunities for initiating social interactions. The broad, overarching objective of this work is to conduct basic experimental research on social connectedness to test whether, how, where, and for whom health communication messages can motivate in-person interactions to reduce young adults' social isolation and loneliness. Our multi-disciplinary team brings together expertise in social psychology, emotion science, communication science, and public health and will carry out a 6-week randomized controlled trial-the Keep Social RCT-using our innovative and ecologically valid simulated social media platform and a suite of rigorous repeated measures of social behavior, loneliness, and other health relevant outcomes. This program of research is designed to meet three specific aims. SPECIFIC AIM 1 is to use optimized health messages about the value of social connectedness for young adults (ages 18-29) to conduct the Keep Social RCT to build a rich empirical platform. Initial empirical work has already used a human-centered process to design health communication messages that included peer imagery and stories and tested them in an online experiment with \>700 young adults. Messages that received the highest ratings for encouraging in-person interactions in this online experiment were selected for the Keep Social RCT, which is placebo-controlled with behavioral and survey assessments repeated over six weeks. SPECIFIC AIM 2 is to analyze theory-driven mechanisms through which health communication messages in the Keep Social RCT may reduce young adults' social isolation and loneliness to identify intervention targets. This aim will be met with longitudinal statistical modeling to test whether and how the experimental health communication messages improve social connectedness. SPECIFIC AIM 3 is to extend data analyses of the Keep Social RCT to identify moderators of reduced social isolation and loneliness to identify where and for whom effects are largest. This aim will be met with advanced statistical modeling to illuminate the conditions under which our health communication messages most effectively ameliorate social isolation and loneliness in young adults. Taken together, this research will provide a framework to identify intervention targets to guide subsequent translational work undertaken to reduce loneliness that has been increasing across the US.
Age
18 - 29 years
Sex
ALL
Healthy Volunteers
Yes
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Start Date
May 19, 2025
Primary Completion Date
November 1, 2027
Completion Date
November 1, 2027
Last Updated
March 19, 2026
1,900
ESTIMATED participants
Experimental Health Communication
BEHAVIORAL
Simulated Social Media Platform Only
BEHAVIORAL
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04577911