Clinical trial NCT07005817: Keep Social Study for Young Adults
Official title: Ameliorating Social Isolation: Identifying Factors That Impede or Facilitate Health-related Social Behavior Change
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social Isolation
Loneliness
Keywords: Keep Social
Online
Young Adult
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-06-05
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our main models use longitudinal structural equation modeling, multilevel structural equation modeling, and regression analysis. Further details are provided in the statistical analysis plan.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Use social media
* Own a smartphone
* Reside in urban or suburban regions
* Meet one or more criteria for membership in a sociodemographic population with increased risk of adverse health outcomes in the U.S.: at least 500 participants who identity as Black or African American, at least 500 participants who identify as Hispanic, at least 500 participants with low subjective social status - i.e., who report a 5 or lower on the MacArthur Subjective Social Status (SSS) ladder). Groupings are not mutually exclusive.

Exclusion Criteria:

* Reside in rural region

Primary outcomes:
measure: Quantity of locations visited as a potential indicator of social opportunity
timeFrame: Continuous over the duration of the 6-week study
measure: Roaming entropy as a potential indicator of social opportunity
timeFrame: Continuous over the duration of the 6-week study
measure: Loneliness, Self-Report (Biweekly)
timeFrame: Baseline/Week 0, Week 2, Week 4, and Week 6
measure: Loneliness, Self-Report (Day)
timeFrame: Included in Day Reports, 3 times a week, over the 6-week RCT
measure: Behavioral Motivational Value for Strangers-Smiling-with-Direct-Gaze
timeFrame: Week 4
measure: Social Connection, Open Text
timeFrame: Week 6
Secondary outcomes:
measure: Anxiety, Self-Report
timeFrame: Baseline/Week 0, Week 2, Week 4, and Week 6
measure: Depression, Self-Report
timeFrame: Baseline/Week 0, Week 2, Week 4, and Week 6
measure: Stress, Self-Report
timeFrame: Baseline/Week 0, Week 2, Week 4, and Week 6
measure: Flourishing Mental Health, Self-Report
timeFrame: Baseline/Week 0, Week 2, Week 4, and Week 6
measure: Life Satisfaction, Self-Report
timeFrame: Baseline/Week 0, Week 2, Week 4, and Week 6
measure: Belongingness, Self-Report
timeFrame: Baseline/Week 0, Week 2, Week 4, and Week 6
measure: Alcohol Consumption
timeFrame: Week 2 and Week 6
measure: Illness Symptoms, Self-Report
timeFrame: Included in Day Reports, 3 times a week, over the 6-week RCT
measure: Physical Pain, Self-Report
timeFrame: Included in Day Reports, 3 times a week, over the 6-week RCT
Other outcomes:
measure: Motivation for Recommended Health Behavior
timeFrame: Week 2 (experimental group only)
measure: Perceived Message Effectiveness, Self-Report
timeFrame: Included in Day Reports, 3 times a week, over the 6-week RCT
measure: Message Relevance, Self-Report
timeFrame: Included in Day Reports, 3 times a week, over the 6-week RCT
measure: Perceived Social Presence, Self-Report
timeFrame: Included in Day Reports, 3 times a week, over the 6-week RCT
measure: Behavioral Adherence, Self-Report
timeFrame: Included in Day Reports, 3 times a week, over the 6-week RCT
measure: Quantity of Social Interactions, Self-Report
timeFrame: Included in Day Reports, 3 times a week, over the 6-week RCT
measure: Emotional Quality of Social Interactions, Self-Report
timeFrame: Included in Day Reports, 3 times a week, over the 6-week RCT
measure: Positive Emotions, Explicit Self-Report
timeFrame: Included in Day Reports, 3 times per week, over the 6-week RCT
measure: Perceived Incivility, Self-Report
timeFrame: Included in Day Reports, 3 times a week, over the 6-week RCT
measure: Prioritizing Positivity, Self-Report
timeFrame: Baseline/Week 0 and Week 6
measure: Prioritizing Positivity Resonance, Self-Report
timeFrame: Baseline/Week 0 and Week 6
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Barbara L. Frederickson, PhD
role: PRINCIPAL_INVESTIGATOR
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