Trial Outcomes & Findings for Physical Activity Intervention for Adolescent Girls (NCT NCT04190225)
NCT ID: NCT04190225
Last Updated: 2025-12-09
Results Overview
The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from baseline to 6 months. (waking hours only) to measure movement and intensity of activity
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
Baseline, 6 Months (MO)
Results posted on
2025-12-09
Participant Flow
306 individuals were screened for eligibility. Of these 188 were eligible. Primary reasons for ineligibility were being too active (65), being outside the age range (24), BMI too high (4), not having access to technology (2), not living in the area (4), not speaking English (3), not being female or Latina (5), and other (10). Of the 188 eligible, 28 declined to participate after learning more about the study.
Participant milestones
| Measure |
Control
Control group receives a Fitbit but none of the intervention components.
|
Multi-technology Physical Activity Intervention
Digital/social media
Digital/social media intervention: Participants will receive individual counseling, access to an individually tailored website, guided goal setting via texts, access to a study Instagram account, and a wearable tracker (Fitbit)
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
77
|
|
Overall Study
COMPLETED
|
78
|
70
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Control
Control group receives a Fitbit but none of the intervention components.
|
Multi-technology Physical Activity Intervention
Digital/social media
Digital/social media intervention: Participants will receive individual counseling, access to an individually tailored website, guided goal setting via texts, access to a study Instagram account, and a wearable tracker (Fitbit)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Unrelated health condition
|
0
|
2
|
Baseline Characteristics
Physical Activity Intervention for Adolescent Girls
Baseline characteristics by cohort
| Measure |
Multi-technology Physical Activity Intervention
n=77 Participants
Digital/social media
Digital/social media intervention: Participants will receive individual counseling, access to an individually tailored website, guided goal setting via texts, access to a study Instagram account, and a wearable tracker (Fitbit)
|
Control
n=83 Participants
Control group receives a Fitbit but none of the intervention components.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Parent Education
At least some college
|
35 Participants
n=9 Participants
|
39 Participants
n=6 Participants
|
74 Participants
n=9 Participants
|
|
Age, Continuous
|
15.8 years
STANDARD_DEVIATION 1.7 • n=9 Participants
|
15.9 years
STANDARD_DEVIATION 1.5 • n=6 Participants
|
15.9 years
STANDARD_DEVIATION 1.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=9 Participants
|
83 Participants
n=6 Participants
|
160 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
77 Participants
n=9 Participants
|
83 Participants
n=6 Participants
|
160 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=9 Participants
|
33 Participants
n=6 Participants
|
68 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
12 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=9 Participants
|
43 Participants
n=6 Participants
|
74 Participants
n=9 Participants
|
|
Body Mass Index
|
26.2 kg/m^2
STANDARD_DEVIATION 5.5 • n=9 Participants
|
25.2 kg/m^2
STANDARD_DEVIATION 6.6 • n=6 Participants
|
25.7 kg/m^2
STANDARD_DEVIATION 6.1 • n=9 Participants
|
|
Primary Language
Mostly Spanish
|
4 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
Primary Language
Spanish and English equally
|
21 Participants
n=9 Participants
|
31 Participants
n=6 Participants
|
52 Participants
n=9 Participants
|
|
Primary Language
English more than Spanish
|
47 Participants
n=9 Participants
|
37 Participants
n=6 Participants
|
84 Participants
n=9 Participants
|
|
Primary Language
Only English
|
5 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
14 Participants
n=9 Participants
|
|
Generation Status
First
|
6 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
13 Participants
n=9 Participants
|
|
Generation Status
Second
|
53 Participants
n=9 Participants
|
57 Participants
n=6 Participants
|
110 Participants
n=9 Participants
|
|
Generation Status
Third
|
18 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
37 Participants
n=9 Participants
|
|
Parent Education
High school or less
|
42 Participants
n=9 Participants
|
44 Participants
n=6 Participants
|
86 Participants
n=9 Participants
|
|
Family Income
<$50,000
|
45 Participants
n=9 Participants
|
54 Participants
n=6 Participants
|
99 Participants
n=9 Participants
|
|
Family Income
≥$50,000
|
32 Participants
n=9 Participants
|
29 Participants
n=6 Participants
|
61 Participants
n=9 Participants
|
|
Number of children in home
|
2.01 number of children
STANDARD_DEVIATION 1.2 • n=9 Participants
|
1.93 number of children
STANDARD_DEVIATION 1.2 • n=6 Participants
|
1.97 number of children
STANDARD_DEVIATION 1.2 • n=9 Participants
|
|
Neighborhood Walkability - Street Connectivity
|
2.83 units on a scale
STANDARD_DEVIATION 0.6 • n=9 Participants
|
2.84 units on a scale
STANDARD_DEVIATION 0.6 • n=6 Participants
|
2.83 units on a scale
STANDARD_DEVIATION 0.6 • n=9 Participants
|
|
Neighborhood Environment
|
4.96 units on a scale
STANDARD_DEVIATION 1.2 • n=9 Participants
|
4.57 units on a scale
STANDARD_DEVIATION 1.4 • n=6 Participants
|
4.77 units on a scale
STANDARD_DEVIATION 1.3 • n=9 Participants
|
|
Physical Activity Enjoyment
|
4.67 units on a scale
STANDARD_DEVIATION 0.92 • n=9 Participants
|
5.03 units on a scale
STANDARD_DEVIATION 0.93 • n=6 Participants
|
4.86 units on a scale
STANDARD_DEVIATION 0.94 • n=9 Participants
|
|
Depressive Symptoms
|
10.62 units on a scale
STANDARD_DEVIATION 3.9 • n=9 Participants
|
11.14 units on a scale
STANDARD_DEVIATION 4.7 • n=6 Participants
|
10.9 units on a scale
STANDARD_DEVIATION 4.3 • n=9 Participants
|
|
Self-Efficacy for Physical Activity
|
1.98 units on a scale
STANDARD_DEVIATION 0.54 • n=9 Participants
|
2.03 units on a scale
STANDARD_DEVIATION 0.46 • n=6 Participants
|
2.01 units on a scale
STANDARD_DEVIATION 0.50 • n=9 Participants
|
|
Social Support for Exercise
|
20.5 units on a scale
STANDARD_DEVIATION 13.4 • n=9 Participants
|
24.2 units on a scale
STANDARD_DEVIATION 16.7 • n=6 Participants
|
22.4 units on a scale
STANDARD_DEVIATION 15.3 • n=9 Participants
|
|
Maternal Support for Exercise
|
2.46 units on a scale
STANDARD_DEVIATION 0.75 • n=9 Participants
|
2.55 units on a scale
STANDARD_DEVIATION 0.64 • n=6 Participants
|
2.51 units on a scale
STANDARD_DEVIATION 0.69 • n=9 Participants
|
|
Exercise Stage of Change
Pre-contemplation
|
3 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
|
Exercise Stage of Change
Contemplation
|
10 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
|
Exercise Stage of Change
Preparation
|
64 Participants
n=9 Participants
|
70 Participants
n=6 Participants
|
134 Participants
n=9 Participants
|
|
ActiGraph Physical Activity
|
0 minutes of activity
n=9 Participants
|
0 minutes of activity
n=6 Participants
|
0 minutes of activity
n=9 Participants
|
|
Self-Reported Physical Activity
|
119 minutes of activity
n=9 Participants
|
120 minutes of activity
n=6 Participants
|
120 minutes of activity
n=9 Participants
|
|
Daily Steps
|
5196 average daily steps across one week
STANDARD_DEVIATION 3116 • n=9 Participants
|
5275 average daily steps across one week
STANDARD_DEVIATION 3191 • n=6 Participants
|
5222 average daily steps across one week
STANDARD_DEVIATION 3359 • n=9 Participants
|
|
Land-use mix - NEWS-Y
|
2.47 units on a scale
STANDARD_DEVIATION 0.62 • n=9 Participants
|
2.37 units on a scale
STANDARD_DEVIATION 0.81 • n=6 Participants
|
2.42 units on a scale
STANDARD_DEVIATION 0.73 • n=9 Participants
|
|
Recreation Facilities - NEWS-Y
|
2.27 units on a scale
STANDARD_DEVIATION 0.68 • n=9 Participants
|
2.21 units on a scale
STANDARD_DEVIATION 0.76 • n=6 Participants
|
2.24 units on a scale
STANDARD_DEVIATION 0.72 • n=9 Participants
|
|
Residential Density - NEWS-Y
|
112 units on a scale
STANDARD_DEVIATION 39.1 • n=9 Participants
|
109 units on a scale
STANDARD_DEVIATION 40.3 • n=6 Participants
|
111 units on a scale
STANDARD_DEVIATION 39.6 • n=9 Participants
|
|
Land use access - NEWS-Y
|
2.94 units on a scale
STANDARD_DEVIATION 0.50 • n=9 Participants
|
3.01 units on a scale
STANDARD_DEVIATION 0.50 • n=6 Participants
|
2.98 units on a scale
STANDARD_DEVIATION 0.50 • n=9 Participants
|
|
Walking/cycling facilities - NEWS-Y
|
3.07 units on a scale
STANDARD_DEVIATION 0.59 • n=9 Participants
|
3.05 units on a scale
STANDARD_DEVIATION 0.66 • n=6 Participants
|
3.06 units on a scale
STANDARD_DEVIATION 0.63 • n=9 Participants
|
|
Neighborhood aesthetics - NEWS-Y
|
2.74 units on a scale
STANDARD_DEVIATION 0.66 • n=9 Participants
|
2.89 units on a scale
STANDARD_DEVIATION 0.73 • n=6 Participants
|
2.82 units on a scale
STANDARD_DEVIATION 0.7 • n=9 Participants
|
|
Safety from traffic - NEWS-Y
|
2.78 units on a scale
STANDARD_DEVIATION 0.45 • n=9 Participants
|
2.79 units on a scale
STANDARD_DEVIATION 0.45 • n=6 Participants
|
2.78 units on a scale
STANDARD_DEVIATION 0.45 • n=9 Participants
|
|
Safety from crime
|
2.26 units on a scale
STANDARD_DEVIATION 0.78 • n=9 Participants
|
2.19 units on a scale
STANDARD_DEVIATION 0.75 • n=6 Participants
|
2.22 units on a scale
STANDARD_DEVIATION 0.76 • n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 Months (MO)The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from baseline to 6 months. (waking hours only) to measure movement and intensity of activity
Outcome measures
| Measure |
Multi-technology Physical Activity Intervention
n=70 Participants
Digital/social media
Digital/social media intervention: Participants will receive individual counseling, access to an individually tailored website, guided goal setting via texts, access to a study Instagram account, and a wearable tracker (Fitbit)
|
Control
n=78 Participants
Control group receives a Fitbit but none of the intervention components.
|
|---|---|---|
|
Objectively Measured Weekly Minutes of Activity
|
64 weekly minutes of activity
Interval 19.0 to 72.0
|
41 weekly minutes of activity
Interval 7.0 to 76.0
|
PRIMARY outcome
Timeframe: Baseline, 6 Months (MO)The 7-Day Physical Activity Recall (PAR) will also assess self-reported changes in physical activity from baseline to 6 months. The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities. The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
Outcome measures
| Measure |
Multi-technology Physical Activity Intervention
n=70 Participants
Digital/social media
Digital/social media intervention: Participants will receive individual counseling, access to an individually tailored website, guided goal setting via texts, access to a study Instagram account, and a wearable tracker (Fitbit)
|
Control
n=78 Participants
Control group receives a Fitbit but none of the intervention components.
|
|---|---|---|
|
Self-Reported Weekly Minutes of Activity
|
147 minutes of activity per week
Interval 96.0 to 181.0
|
124 minutes of activity per week
Interval 100.0 to 169.0
|
SECONDARY outcome
Timeframe: 12 monthsweekly minutes of moderate-to-vigorous physical activity measured by ActiGraph accelerometer
Outcome measures
| Measure |
Multi-technology Physical Activity Intervention
n=65 Participants
Digital/social media
Digital/social media intervention: Participants will receive individual counseling, access to an individually tailored website, guided goal setting via texts, access to a study Instagram account, and a wearable tracker (Fitbit)
|
Control
n=70 Participants
Control group receives a Fitbit but none of the intervention components.
|
|---|---|---|
|
Objectively Measured Weekly Minutes Minutes of Activity
|
74 weekly minutes of activity
Interval 32.0 to 120.0
|
37 weekly minutes of activity
Interval 12.0 to 91.0
|
Adverse Events
Multi-technology Physical Activity Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place