Trial Outcomes & Findings for Fit 24 Technology Intervention YOUTH (NCT NCT04953442)

Results Overview

We will record the number participants recruited, screened, and enrolled in the study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

4 months

Results posted on

2025-09-15

Participant Flow

Youth were recruited from local pediatric clinics, community-based organizations (eg, Houston Public Library and Baker Ripley Community Developers), and by word of mouth. Interested participants were screened via telephone for eligibility criteria.

After baeline data collection participating youth were randomized (1:1 randomization) to the intervention or to a waitlist control group. The youth in the intervention received a Fitbit Charge 5 device and daily SMS text messages grounded in SDT. Youth randomized to the waitlist control group received a Fitbit Charge 5 device and a one-page informational handout on PA and sleep guidelines.

Participant milestones

Participant milestones
Measure	Wait List Control Youth randomized to the waitlist control group received a Fitbit Charge 5 device and a one-page informational handout on PA and sleep guidelines.	Intervention The youth in the intervention received a Fitbit Charge 5 device and daily SMS text messages grounded in SDT.
Overall Study STARTED	21	22
Overall Study COMPLETED	18	22
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex was self-reported as sex assigned at birth.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=22 Participants Fitbit Device Self-Determination Theory Text Messages	Wait List Control n=21 Participants Informational flyer of evidence-based strategies on engaging in healthy physical activity and sleep lifestyle habits.	Total n=43 Participants Total of all reporting groups
Age, Continuous	15.09 years STANDARD_DEVIATION 0.768 • n=5 Participants	14.95 years STANDARD_DEVIATION 0.95 • n=7 Participants	15.02 years STANDARD_DEVIATION 0.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants • Sex was self-reported as sex assigned at birth.	13 Participants n=7 Participants • Sex was self-reported as sex assigned at birth.	27 Participants n=5 Participants • Sex was self-reported as sex assigned at birth.
Sex: Female, Male Male	8 Participants n=5 Participants • Sex was self-reported as sex assigned at birth.	8 Participants n=7 Participants • Sex was self-reported as sex assigned at birth.	16 Participants n=5 Participants • Sex was self-reported as sex assigned at birth.
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants • Self Reported demographic survey completed by parents	21 Participants n=7 Participants • Self Reported demographic survey completed by parents	43 Participants n=5 Participants • Self Reported demographic survey completed by parents
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants • Self Reported demographic survey completed by parents	0 Participants n=7 Participants • Self Reported demographic survey completed by parents	0 Participants n=5 Participants • Self Reported demographic survey completed by parents
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Self Reported demographic survey completed by parents	0 Participants n=7 Participants • Self Reported demographic survey completed by parents	0 Participants n=5 Participants • Self Reported demographic survey completed by parents

PRIMARY outcome

Timeframe: 4 months

Population: This is the count of participants that were enrolled in each intervention arm.

We will record the number participants recruited, screened, and enrolled in the study.

Outcome measures

Outcome measures
Measure	Wait List Control n=21 Participants Youth randomized to the waitlist control group received a Fitbit Charge 5 device and a one-page informational handout on PA and sleep guidelines.	Intervention n=22 Participants The youth in the intervention received a Fitbit Charge 5 device and daily SMS text messages grounded in SDT.
Number Participants Recruited	21 Participants	22 Participants

PRIMARY outcome

Timeframe: 12-weeks

We will record the number of technical issues experienced by participants throughout the study.

Outcome measures

Outcome measures
Measure	Wait List Control n=21 Participants Youth randomized to the waitlist control group received a Fitbit Charge 5 device and a one-page informational handout on PA and sleep guidelines.	Intervention n=22 Participants The youth in the intervention received a Fitbit Charge 5 device and daily SMS text messages grounded in SDT.
Number of Technical Issues Experienced by Participants	0 number of technical issues	16 number of technical issues

PRIMARY outcome

Timeframe: 12-weeks

Population: Only participants originally randomized to the intervention completed the exit survey to indicate their satisfaction with the intervention.

We will use a survey to assess the % of participants that are satisfied with participation in the study.

Outcome measures

Outcome measures
Measure	Wait List Control Youth randomized to the waitlist control group received a Fitbit Charge 5 device and a one-page informational handout on PA and sleep guidelines.	Intervention n=22 Participants The youth in the intervention received a Fitbit Charge 5 device and daily SMS text messages grounded in SDT.
Percentage of Participants That Are Satisfied With Participation in the Study	0 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline and 12-weeks post intervention

Physical activity was measured using accelerometry for a 7 day protocol.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Sleep will be assessed using accelerometry to assess average minutes/night using a 24-hour, 7-day accelerometer protocol.

Outcome measures

Outcome measures
Measure	Wait List Control n=22 Participants Youth randomized to the waitlist control group received a Fitbit Charge 5 device and a one-page informational handout on PA and sleep guidelines.	Intervention n=21 Participants The youth in the intervention received a Fitbit Charge 5 device and daily SMS text messages grounded in SDT.
Average of Minutes of Sleep Per Night	503.3 minutes/night Standard Deviation 87.7	470.98 minutes/night Standard Deviation 60.54

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Height and weight will be measured to the nearest 0.1cm and 0.1 kg, using a portable stadiometer and research scale to calculate BMI percentile.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

The Psychological Need Satisfaction in Exercise Scale (18-items) will be used to assess psychological needs fulfillment. The total possible scores in the PNSE are 6-108 with higher scores reflect greater perceptions of psychological need fulfillment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

The Behavioural Regulation in Exercise Questionnaire-2 (23-items) will be used to assess autonomous motivation for physical activity. The total possible scores on the BREQ-2 are -24 to 24, with a higher score indicating reflect more self-determined motivation whereas negative scores indicate less self-determined motivation.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait List Control

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

Erica Soltero, PhD

Baylor College of Medicine

Phone: 4029100832

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place