Using Social Connectedness to Increase Physical Activity

• Sponsor: Carnegie Mellon University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04573972
• Collaborator: University of Virginia (Other)
• Enrollment: 172
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 54.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Activity, Motor; Social Isolation	Behavioral: Social Incentive; Behavioral: Standard Incentive	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 172 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two group, between-subjects designTwo group, between-subjects design
• Masking: Single (Outcomes Assessor)
• Masking Description: The primary outcome is steps walked, as assessed via the Fitbit app, which is blind to study condition.
• Primary Purpose: Basic Science
• Official Title: Using Social Connectedness to Increase Physical Activity
• Actual Study Start Date: Sep 30, 2020
• Actual Primary Completion Date: Nov 25, 2020
• Actual Study Completion Date: Jan 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change in Mean Daily Steps Walked From Baseline Period (Week 1) to Intervention Period (Weeks 2 and 3) [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

2. Change in Mean Daily Steps Walked From Baseline Period (Week 1) to Follow-up Period (Weeks 4-5) [week 4-5]

   Change in mean daily steps walked from baseline to follow-up period, as recorded on the FitBit app

3. 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) [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)

4. 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) [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)

5. Change in Score on University of California Los Angeles (UCLA) Loneliness Scale (Survey Measure) [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).

Secondary Outcome Measures

1. Fraction of Days Participant Walked Together With Partner (Self Report) During Intervention Period (Weeks 2-3) [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)

2. Fraction of Days Participant Walked Together With Partner (Self Report) During Follow-up Period (Weeks 4-5) [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)

3. Fraction of Days Participant Walked Together With Partner (Coded) During the Intervention Period (Weeks 2-3) [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. The fraction of days when the participant walked at least 2,000 steps with the partner will be computed. Note that this ML algorithm is still in development and will not be ready for quite some time.

4. Fraction of Days Participant Walked Together With Partner (Coded) During Follow-up Period [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. The fraction of days when the participant walked at least 2,000 steps with the partner will be computed. Note that this ML algorithm is still in development and will not be ready for quite some time.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carnegie Mellon University	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Carnegie Mellon University
• University of Virginia

Investigators

• Principal Investigator: GRETCHEN B CHAPMAN, PhD, Carnegie Mellon University

Study Documents (Full-Text)

• Study Protocol - Oct 22, 2021
• Statistical Analysis Plan - Oct 22, 2021

More Information

Publications

None provided.

• Responsible Party: Gretchen Chapman, Professor, Carnegie Mellon University
• ClinicalTrials.gov Identifier: NCT04573972
• Other Study ID Numbers: STUDY2019_00000296
• First Posted: Oct 5, 2020
• Last Update Posted: Mar 8, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gretchen Chapman, Professor, Carnegie Mellon University: incentives

Study Results

Participant Flow

Recruitment Details	Note: all number shown here represent individual participants (not dyads).

Arm/Group Title	Regular Incentive	Social Incentive
Arm/Group Description	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together	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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
Period Title: Overall Study
STARTED	88	84
COMPLETED	56	70
NOT COMPLETED	32	14

Baseline Characteristics

Arm/Group Title	Regular Incentive	Social Incentive	Total
Arm/Group Description	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together	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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together	Total of all reporting groups
Overall Participants	56	70	126
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.77 (8.34)	20.16 (5.67)	20.87 (7.00)
Sex/Gender, Customized (Count of Participants)
female	35 62.5%	44 62.9%	79 62.7%
male	21 37.5%	20 28.6%	41 32.5%
other	0 0%	5 7.1%	5 4%
prefer not to answer	0 0%	1 1.4%	1 0.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 8.9%	2 2.9%	7 5.6%
Not Hispanic or Latino	51 91.1%	68 97.1%	119 94.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	31 55.4%	48 68.6%	79 62.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 3.6%	2 2.9%	4 3.2%
White	19 33.9%	14 20%	33 26.2%
More than one race	2 3.6%	4 5.7%	6 4.8%
Unknown or Not Reported	2 3.6%	2 2.9%	4 3.2%

Outcome Measures

1. Primary Outcome

Title	Change in Mean Daily Steps Walked From Baseline Period (Week 1) to Intervention Period (Weeks 2 and 3)
Description	Change in mean daily steps walked from baseline (week 1) to intervention period (weeks 2 and 3), as recorded on the FitBit app
Time Frame	week 2-3

Outcome Measure Data

Analysis Population Description

Numbers refer to individuals (not dyads).

Arm/Group Title	Regular Incentive	Social Incentive
Arm/Group Description	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together	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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
Measure Participants	56	70
Least Squares Mean (Standard Deviation) [steps per day]	483.95 (324.64)	283.77 (344.89)

2. Primary Outcome

Title	Change in Mean Daily Steps Walked From Baseline Period (Week 1) to Follow-up Period (Weeks 4-5)
Description	Change in mean daily steps walked from baseline to follow-up period, as recorded on the FitBit app
Time Frame	week 4-5

Outcome Measure Data

Analysis Population Description

Numbers refer to individuals (not dyads).

Arm/Group Title	Regular Incentive	Social Incentive
Arm/Group Description	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together	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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
Measure Participants	56	70
Least Squares Mean (Standard Deviation) [steps per day]	7.33 (271.25)	159.76 (240.34)

3. Primary Outcome

Title	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)
Description	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)
Time Frame	week 2-3

Outcome Measure Data

Analysis Population Description

Numbers refer to individuals (not dyads).

Arm/Group Title	Regular Incentive	Social Incentive
Arm/Group Description	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together	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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
Measure Participants	56	70
Least Squares Mean (Standard Deviation) [days]	0.03 (0.05)	0.01 (0.05)

4. Primary Outcome

Title	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)
Description	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)
Time Frame	week 4-5

Outcome Measure Data

Analysis Population Description

Numbers refer to individuals (not dyads).

Arm/Group Title	Regular Incentive	Social Incentive
Arm/Group Description	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together	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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
Measure Participants	56	70
Least Squares Mean (Standard Deviation) [days]	-0.04 (0.04)	-0.02 (0.05)

5. Primary Outcome

Title	Change in Score on University of California Los Angeles (UCLA) Loneliness Scale (Survey Measure)
Description	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).
Time Frame	week 5

Outcome Measure Data

Analysis Population Description

Numbers refer to individuals (not dyads).

Arm/Group Title	Regular Incentive	Social Incentive
Arm/Group Description	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together	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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
Measure Participants	56	70
Least Squares Mean (Standard Deviation) [score on a scale]	-0.01 (0.08)	0.02 (0.09)

6. Secondary Outcome

Title	Fraction of Days Participant Walked Together With Partner (Self Report) During Intervention Period (Weeks 2-3)
Description	Fraction of days with self report of walking at least 2,000 steps with another participant during intervention period (weeks 2-3)
Time Frame	week 2-3

Outcome Measure Data

Analysis Population Description

Numbers refer to individuals (not dyads).

Arm/Group Title	Regular Incentive	Social Incentive
Arm/Group Description	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together	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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
Measure Participants	51	67
Least Squares Mean (Standard Error) [proportion of days]	0.138 (0.065)	0.535 (0.070)

7. Secondary Outcome

Title	Fraction of Days Participant Walked Together With Partner (Self Report) During Follow-up Period (Weeks 4-5)
Description	Fraction of days with self report of walking at least 2,000 steps with another participant during follow-up period (weeks 3-5)
Time Frame	week 4-5

Outcome Measure Data

Analysis Population Description

Numbers refer to individuals (not dyads).

Arm/Group Title	Regular Incentive	Social Incentive
Arm/Group Description	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together	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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
Measure Participants	51	64
Least Squares Mean (Standard Error) [proportion of days]	0.135 (0.077)	0.408 (0.086)

8. Secondary Outcome

Title	Fraction of Days Participant Walked Together With Partner (Coded) During the Intervention Period (Weeks 2-3)
Description	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. The fraction of days when the participant walked at least 2,000 steps with the partner will be computed. Note that this ML algorithm is still in development and will not be ready for quite some time.
Time Frame	week 2-3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Fraction of Days Participant Walked Together With Partner (Coded) During Follow-up Period
Description	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. The fraction of days when the participant walked at least 2,000 steps with the partner will be computed. Note that this ML algorithm is still in development and will not be ready for quite some time.
Time Frame	week 4-5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	5 weeks
Adverse Event Reporting Description	Definitions do not differ Note: Numbers below indicate individuals (not dyads) The number of "at risk" individuals includes all individuals who started the study flow, even those that did not meet inclusion criteria and did no receive any intervention.
Arm/Group Title	Regular Incentive		Social Incentive
Arm/Group Description	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together		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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
All Cause Mortality
	Regular Incentive		Social Incentive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/88 (0%)		0/84 (0%)
Serious Adverse Events
	Regular Incentive		Social Incentive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/88 (0%)		0/84 (0%)
Other (Not Including Serious) Adverse Events
	Regular Incentive		Social Incentive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/88 (0%)		0/84 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.