Trial Outcomes & Findings for Using Social Connectedness to Increase Physical Activity (NCT NCT04573972)

NCT ID: NCT04573972

Last Updated: 2024-03-28

Results Overview

Change in mean daily steps walked from baseline (week 1) to intervention period (weeks 2 and 3), as recorded on the FitBit app

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 172 participants
• Primary outcome timeframe: week 2-3
• Results posted on: 2024-03-28

Participant Flow

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

Participant milestones

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

Reasons for withdrawal

Measure	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. Standard Incentive: Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together	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. Social Incentive: Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
Overall Study Dyad partner did not join study or did not walk >0 steps	32	14

Baseline Characteristics

Following our pre-registration, we omitted participants from analysis if the participant's dyad partner did not complete enrollment in the study, if the participant did not have at least 1 baseline day where >0 steps were recorded, or if the participant's dyad partner did not have at least 1 baseline day where >0 steps were recorded.

Baseline characteristics by cohort

Measure	Regular Incentive n=56 Participants 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	Social Incentive n=70 Participants 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 n=126 Participants Total of all reporting groups
Age, Continuous	21.77 years STANDARD_DEVIATION 8.34 • n=5 Participants • Following our pre-registration, we omitted participants from analysis if the participant's dyad partner did not complete enrollment in the study, if the participant did not have at least 1 baseline day where \>0 steps were recorded, or if the participant's dyad partner did not have at least 1 baseline day where \>0 steps were recorded.	20.16 years STANDARD_DEVIATION 5.67 • n=7 Participants • Following our pre-registration, we omitted participants from analysis if the participant's dyad partner did not complete enrollment in the study, if the participant did not have at least 1 baseline day where \>0 steps were recorded, or if the participant's dyad partner did not have at least 1 baseline day where \>0 steps were recorded.	20.87 years STANDARD_DEVIATION 7.00 • n=5 Participants • Following our pre-registration, we omitted participants from analysis if the participant's dyad partner did not complete enrollment in the study, if the participant did not have at least 1 baseline day where \>0 steps were recorded, or if the participant's dyad partner did not have at least 1 baseline day where \>0 steps were recorded.
Sex/Gender, Customized Gender · female	35 Participants n=5 Participants	44 Participants n=7 Participants	79 Participants n=5 Participants
Sex/Gender, Customized Gender · male	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex/Gender, Customized Gender · other	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Sex/Gender, Customized Gender · prefer not to answer	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants	68 Participants n=7 Participants	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	31 Participants n=5 Participants	48 Participants n=7 Participants	79 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: week 2-3

Population: Numbers refer to individuals (not dyads).

Change in mean daily steps walked from baseline (week 1) to intervention period (weeks 2 and 3), as recorded on the FitBit app

Outcome measures

Measure	Regular Incentive n=56 Participants 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	Social Incentive n=70 Participants 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
Change in Mean Daily Steps Walked From Baseline Period (Week 1) to Intervention Period (Weeks 2 and 3)	483.95 steps per day Standard Deviation 324.64	283.77 steps per day Standard Deviation 344.89

PRIMARY outcome

Timeframe: week 4-5

Population: Numbers refer to individuals (not dyads).

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

Outcome measures

Measure	Regular Incentive n=56 Participants 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	Social Incentive n=70 Participants 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
Change in Mean Daily Steps Walked From Baseline Period (Week 1) to Follow-up Period (Weeks 4-5)	7.33 steps per day Standard Deviation 271.25	159.76 steps per day Standard Deviation 240.34

PRIMARY outcome

Timeframe: week 2-3

Population: Numbers refer to individuals (not dyads).

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)

Outcome measures

Measure	Regular Incentive n=56 Participants 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	Social Incentive n=70 Participants 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
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)	0.03 days Standard Deviation 0.05	0.01 days Standard Deviation 0.05

PRIMARY outcome

Timeframe: week 4-5

Population: Numbers refer to individuals (not dyads).

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)

Outcome measures

Measure	Regular Incentive n=56 Participants 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	Social Incentive n=70 Participants 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
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)	-0.04 days Standard Deviation 0.04	-0.02 days Standard Deviation 0.05

PRIMARY outcome

Timeframe: week 5

Population: Numbers refer to individuals (not dyads).

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).

Outcome measures

Measure	Regular Incentive n=56 Participants 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	Social Incentive n=70 Participants 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
Change in Score on University of California Los Angeles (UCLA) Loneliness Scale (Survey Measure)	-0.01 score on a scale Standard Deviation 0.08	0.02 score on a scale Standard Deviation 0.09

SECONDARY outcome

Timeframe: week 2-3

Population: Numbers refer to individuals (not dyads).

Fraction of days with self report of walking at least 2,000 steps with another participant during intervention period (weeks 2-3)

Outcome measures

Measure	Regular Incentive n=51 Participants 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	Social Incentive n=67 Participants 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
Fraction of Days Participant Walked Together With Partner (Self Report) During Intervention Period (Weeks 2-3)	0.138 proportion of days Standard Error 0.065	0.535 proportion of days Standard Error 0.070

SECONDARY outcome

Timeframe: week 4-5

Population: Numbers refer to individuals (not dyads).

Fraction of days with self report of walking at least 2,000 steps with another participant during follow-up period (weeks 3-5)

Outcome measures

Measure	Regular Incentive n=51 Participants 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	Social Incentive n=64 Participants 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
Fraction of Days Participant Walked Together With Partner (Self Report) During Follow-up Period (Weeks 4-5)	0.135 proportion of days Standard Error 0.077	0.408 proportion of days Standard Error 0.086

SECONDARY outcome

Timeframe: week 2-3

Population: Participants with step data available for algorithm estimate

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

Outcome measures

Measure	Regular Incentive n=34 Participants 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	Social Incentive n=30 Participants 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
Proportion of Days Participant Walked Together With Partner (Coded)	0.5564 proportion of days walked together Standard Error 0.06213	0.7091 proportion of days walked together Standard Error 0.06306

SECONDARY outcome

Timeframe: week 4-5

Population: Participants with step data available for algorithm estimate

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

Outcome measures

Measure	Regular Incentive n=30 Participants 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	Social Incentive n=24 Participants 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
Proportion of Days Participant Walked Together With Partner (Coded)	0.5444 proportion of days walked together Standard Error 0.07536	0.6583 proportion of days walked together Standard Error 0.08425

Adverse Events

Regular Incentive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Social Incentive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gretchen Chapman, PhD

Carnegie Mellon University

Phone: 4122687380

Email: gchapman@andrew.cmu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place