Using Social Connectedness to Increase Physical Activity

October 2, 2023 updated by: Gretchen Chapman, Carnegie Mellon University
A randomized controlled trial will test the effectiveness of social incentives relative to traditional incentives in promoting walking behavior among college students (N=200). Participants who are rewarded for walking together will be compared to those who are rewarded for walking even when alone. Research participants will download activity tracking apps (Fitbit app and AWARE app) that provide activity and location data. Participants will be consented and then randomized to one of two incentive schemes for walking. Over a 2-week intervention period, the standard incentive group will earn $2 per day when they meet their walking goal regardless of whether they walk alone or with others. The social incentive group will earn $1 per day when they reach their walking goal plus an additional $1 when they walk at least 2000 steps with their walking partner. The incentive scheme will be in place for 2-weeks, preceded by a 1-week baseline period and followed by a 2-week follow-up period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of the study is to test whether social incentives that encourage physical activity with another person are more effective than incentives for individual exercise. Physical inactivity and social isolation are growing epidemics linked to increased morbidity and mortality particularly among aging Americans. This research aims to address both problems by encouraging co-productive physical activities among college students. Co-productive physical activity mean anything involving physical activity that two people can do together, e.g., walking their dogs or shopping together. Additionally, in light of the COVID-19 pandemic, walking together in this study means either walking while communicating digitally or over the phone, or by physically walking together while wearing a mask, staying 6 feet apart, and following the recommendations from health professionals. A small randomized controlled trial will test the effectiveness of social incentives relative to traditional incentives in promoting walking behavior. Participants who are rewarded for walking together will be compared to those who are rewarded for walking even when alone. The results will indicate whether social incentives are more motivating than traditional incentives for walking behavior.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Carnegie Mellon University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18+
  • Able to read and understand English-language surveys
  • Own either iPhone or Android smartphones
  • Willing to carry the smart phone during the study period and to respond to daily texts or emails from the study team
  • Registered for the study as a dyad (friend pairs), with one member of the dyad a Carnegie Mellon University student

Exclusion Criteria:

• Contraindications for increased physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Regular incentive
During the two-week intervention period, the standard incentive group will earn $2 per day when they meet their step goal, and this reward is earned regardless of whether they walk alone or with others.
Behavioral: Standard Incentive
Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together
Experimental: Social Incentive
During the two-week intervention period, he social incentive group will earn $1 per day when they meet their step goal and an additional $1 if they walk 2,000 steps together with another study participant.
Behavioral: Social Incentive
Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Mean Daily Steps Walked From Baseline Period (Week 1) to Intervention Period (Weeks 2 and 3)
Time Frame: week 2-3
Change in mean daily steps walked from baseline (week 1) to intervention period (weeks 2 and 3), as recorded on the FitBit app
week 2-3
Change in Mean Daily Steps Walked From Baseline Period (Week 1) to Follow-up Period (Weeks 4-5)
Time Frame: week 4-5
Change in mean daily steps walked from baseline to follow-up period, as recorded on the FitBit app
week 4-5
Mean Number of Days Met Daily Step Goal During Intervention Period (Weeks 2-3) Minus Mean Number of Days Met Same Level of Walking in Baseline Period (Week 1)
Time Frame: week 2-3
Mean number of days when an individual's number of steps walked was at or above daily goal during the intervention period (weeks 2 & 3) minus the mean number of days the individual's number of step's walking was at or above that same level during the baseline period (week 1)
week 2-3
Mean Number of Days Met Daily Step Goal During Follow-up Period (Weeks 4-5) Minus Mean Number of Days Met Same Level of Walking in Baseline Period (Week 1)
Time Frame: week 4-5
Mean number of days when an individual's number of steps walked was at or above daily goal during the follow-up period (weeks 4 & 5) minus the mean number of days the individual's number of step's walking was at or above that same level during the baseline period (week 1)
week 4-5
Change in Score on University of California Los Angeles (UCLA) Loneliness Scale (Survey Measure)
Time Frame: week 5
20-item scale measuring subjective feelings of loneliness and social isolation. Minimum score = 0; maximum score = 60; higher scores indicate more loneliness. We computed the difference in score from baseline (beginning of week 1) to end of study (end of week 5).
week 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fraction of Days Participant Walked Together With Partner (Self Report) During Intervention Period (Weeks 2-3)
Time Frame: week 2-3
Fraction of days with self report of walking at least 2,000 steps with another participant during intervention period (weeks 2-3)
week 2-3
Fraction of Days Participant Walked Together With Partner (Self Report) During Follow-up Period (Weeks 4-5)
Time Frame: week 4-5
Fraction of days with self report of walking at least 2,000 steps with another participant during follow-up period (weeks 3-5)
week 4-5
Proportion of Days Participant Walked Together With Partner (Coded)
Time Frame: week 2-3
A machine learning (ML) algorithm will compare the walking records from the Aware app of each dyad of participants and assess whether they walked together on each day
week 2-3
Proportion of Days Participant Walked Together With Partner (Coded)
Time Frame: week 4-5
A machine learning (ML) algorithm will compare the walking records from the Aware app of each dyad of participants and assess whether they walked together on each day
week 4-5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carnegie Mellon University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Virginia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: GRETCHEN B CHAPMAN, PhD, Carnegie Mellon University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY2019_00000296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only de-identified data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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