Trial Outcomes & Findings for Incentivizing Lifestyle Modification to Reduce Disease Burden (NCT NCT02945332)

Results Overview

This study will determine the miles walked in presence and absence of financial incentive

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

Conclusion of data recording; approximately 10 weeks after the participant begins the study.

Results posted on

2025-11-24

Participant Flow

Recruitment was done by word of mouth and flyer, as only 8 subjects were required. Researchers connected with community/church leaders in the neighborhood to plan the recruitment of subjects for the study.

In total, 13 people were assessed. Four did not meet inclusion criteria, and 1 declined. Eight were enrolled. Subjects were given anonymous identifiers, subject IDs numbered 1-8. Randomization was completed as one-big-block-of-8. Four were chosen to be in the control group; the others received the intervention.

Participant milestones

Participant milestones
Measure	Required Supervised Walking Device: Fitbit Flexes Required supervised walking: The intervention will include meeting at an agreed upon community center location and time convenient for both the participant and the researcher. During these meetings, the participants will engage in indoor walking under the supervision of the researcher. This is to ensure accurate walking distance recording and also to monitor the participants for any potential adverse events. The participants will have the option of walking as long or short as they please, so long that it is less than 20 miles per week. This is to protect the participants from exhaustion or overexertion. Overall activity of this group will be recorded using Fitbit Flexes, worn at all time for the duration of the study. Fitbit Flex	Non-required Supervised Walking Device: Fitbit Flexes Non-required supervised walking: The intervention will include meeting at an agreed upon community center location and time convenient for both the participant and the researcher. During these meetings, the participants will engage in indoor walking under the supervision of the researcher. This is to ensure accurate walking distance recording and also to monitor the participants for any potential adverse events. The participants will have the option of walking as long or short as they please, so long that it is less than 20 miles per week. This is to protect the participants from exhaustion or overexertion. Overall activity of this group will be recorded using Fitbit Flexes, worn at all time for the duration of the study. Fitbit Flex
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Incentivizing Lifestyle Modification to Reduce Disease Burden

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Required Supervised Walking n=4 Participants Device: Fitbit Flexes Required supervised walking: The intervention will include meeting at an agreed upon community center location and time convenient for both the participant and the researcher. During these meetings, the participants will engage in indoor walking under the supervision of the researcher. This is to ensure accurate walking distance recording and also to monitor the participants for any potential adverse events. The participants will have the option of walking as long or short as they please, so long that it is less than 20 miles per week. This is to protect the participants from exhaustion or overexertion. Overall activity of this group will be recorded using Fitbit Flexes, worn at all time for the duration of the study. Fitbit Flex	Non-required Supervised Walking n=4 Participants Device: Fitbit Flexes Non-required supervised walking: The intervention will include meeting at an agreed upon community center location and time convenient for both the participant and the researcher. During these meetings, the participants will engage in indoor walking under the supervision of the researcher. This is to ensure accurate walking distance recording and also to monitor the participants for any potential adverse events. The participants will have the option of walking as long or short as they please, so long that it is less than 20 miles per week. This is to protect the participants from exhaustion or overexertion. Overall activity of this group will be recorded using Fitbit Flexes, worn at all time for the duration of the study. Fitbit Flex	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=45 Participants	4 Participants n=12929 Participants	8 Participants n=6349 Participants
Age, Categorical >=65 years	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Sex: Female, Male Female	2 Participants n=45 Participants	2 Participants n=12929 Participants	4 Participants n=6349 Participants
Sex: Female, Male Male	2 Participants n=45 Participants	2 Participants n=12929 Participants	4 Participants n=6349 Participants
Region of Enrollment United States	4 participants n=45 Participants	4 participants n=12929 Participants	8 participants n=6349 Participants

PRIMARY outcome

Timeframe: Conclusion of data recording; approximately 10 weeks after the participant begins the study.

This study will determine the miles walked in presence and absence of financial incentive