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Physical Activity Intervention for Adolescent Girls

Individually Tailored Physical Activity Intervention for Latina Adolescents: Chicas Fuertes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04190225
Enrollment
160
Registered
2019-12-09
Start date
2020-08-06
Completion date
2024-05-24
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

physical activity, adolescents, teenagers, Latina

Brief summary

This study will conduct a randomized trial to evaluate the efficacy of a theory-based, individually tailored, multi-technology intervention on increasing physical activity in Latina adolescents, compared to a control group receiving only a physical activity tracker (a Fitbit). The investigators will recruit adolescent (age 13-18) Latinas (N=200) who are currently underactive to participate in the 12-month trial. Those randomized to the Intervention arm will receive a one-on-one counseling session and access to an individually tailored multi-media website. Key intervention components will be reinforced through text messaging to aid goal setting, a physical activity tracker (Fitbit) to set goals, track and log activity, and access to a study Instagram account to reinforce exposure to web content. The primary outcome will be increases in moderate-to-vigorous activity between baseline and 6 months. Secondary outcomes will include changes in activity at 12 months, potential mediators of the intervention, costs of delivering the intervention, behavior change trajectories from continuous data from Fitbits, potential moderators, and changes in physiological and psychological variables.

Detailed description

Latina adolescents report low levels of physical activity, with only 3% meeting national physical activity guidelines, and are at high lifetime risk for conditions related to inactivity, such as obesity, metabolic syndrome, and diabetes. Interventions grounded in sound psychosocial theory and leveraging growing technology use in Latina adolescents are needed to reverse patterns of inactivity, establish healthy lifetime habits and reduce widening disparities. The research team has developed and tested individually tailored, culturally adapted web-based interventions to increase moderate-to-vigorous physical activity (MVPA) for Latinos, which significantly increased MVPA in adult Latino men and women. In a recent pilot study (R03NR014329), this intervention was adapted based on formative interviews to make it appropriate for Latina adolescents and tested it in a single-arm pilot trial (N=21). After 12 weeks, retention was high (90.5%) and self-reported MVPA increased from 24.7(26.11) minutes/week at baseline to 79.4(46.8) at follow up (p\<0.001), suggesting good potential efficacy. In closeout interviews, girls expressed a preference to increase audiovideo components of the website and to incorporate other mobile-health technologies, such as texting, smartphone apps, social media, and wearables. Thus, the aim of this study is to conduct a randomized controlled trial (N=200) of an individually tailored, theory-based, multi-technology intervention to increase MVPA in Latina adolescents. The intervention will comprise a counseling session to teach behavior change techniques, an interactive multimedia website with individually tailored content based on principles of the Transtheoretical Model and Social Cognitive Theory, a wearable tracker and smartphone app to reinforce key behavior change techniques, connection with a study Instagram account to reinforce exposure to intervention content, and automated text messages guide continued goal setting. Participants will be randomly assigned to receive the intervention or only a wearable tracker with smartphone app. Activity will be measured at baseline and six-month follow-up using well-established MVPA measures (accelerometers and the 7-Day Physical Activity Recall Interview). It is hypothesized that those randomized to receive the intervention will show significantly greater increases in MVPA at six months than those in the control group. The investigators will also evaluate whether changes in MVPA are mediated by changes in targeted psychosocial constructs (e.g. self-efficacy, social support) or engagement with technology, assess longer-term changes in MVPA at 12 months, and evaluate whether intervention effects are moderated by baseline personal and environmental variables (e.g. age, BMI, neighborhood environment). Costs to deliver the intervention (e.g. staff time, materials, overhead) will be tracked to evaluate costs and cost-effectiveness of both study arms, and the investigators will track contact time to assess whether staff contact is related to study outcomes. The investigators will also explore trajectories of daily activity in both the intervention and control groups using continuous data from wearable trackers. The proposed study will promote a critical preventive health behavior, physical activity, in Latina adolescents using technologies that are pervasive in this high risk, quickly growing population and highly scalable, laying the groundwork for cost-effective, broad reaching interventions with great potential for preventing chronic disease and promoting health and wellbeing throughout the lifespan.

Interventions

BEHAVIORALDigital/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)

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Brown University
CollaboratorOTHER
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

1:1 treatment: control

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* self identify as Latina * 13-18 years old * read, write, speak English * under active (participating in \<150 minutes of moderate to vigorous physical activity per week) * regular access to the Internet (at least 2 times per week) * regular access to a cell phone that can send and receive text messages

Exclusion criteria

* inability to safely engage in physical activity, as determined by the Physical Activity Readiness Questionnaire * BMI \> 45 * Plan to move from the area within 12 months

Design outcomes

Primary

MeasureTime frameDescription
Objectively Measured Weekly Minutes of ActivityBaseline, 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
Self-Reported Weekly Minutes of ActivityBaseline, 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.

Secondary

MeasureTime frameDescription
Objectively Measured Weekly Minutes Minutes of Activity12 monthsweekly minutes of moderate-to-vigorous physical activity measured by ActiGraph accelerometer

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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)
77
Control
Control group receives a Fitbit but none of the intervention components.
83
Total160

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up23
Overall StudyUnrelated health condition20
Overall StudyWithdrawal by Subject32

Baseline characteristics

CharacteristicControlMulti-technology Physical Activity InterventionTotal
ActiGraph Physical Activity0 minutes of activity0 minutes of activity0 minutes of activity
Age, Continuous15.9 years
STANDARD_DEVIATION 1.5
15.8 years
STANDARD_DEVIATION 1.7
15.9 years
STANDARD_DEVIATION 1.3
Body Mass Index25.2 kg/m^2
STANDARD_DEVIATION 6.6
26.2 kg/m^2
STANDARD_DEVIATION 5.5
25.7 kg/m^2
STANDARD_DEVIATION 6.1
Daily Steps5275 average daily steps across one week
STANDARD_DEVIATION 3191
5196 average daily steps across one week
STANDARD_DEVIATION 3116
5222 average daily steps across one week
STANDARD_DEVIATION 3359
Depressive Symptoms11.14 units on a scale
STANDARD_DEVIATION 4.7
10.62 units on a scale
STANDARD_DEVIATION 3.9
10.9 units on a scale
STANDARD_DEVIATION 4.3
Ethnicity (NIH/OMB)
Hispanic or Latino
83 Participants77 Participants160 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Exercise Stage of Change
Contemplation
12 Participants10 Participants22 Participants
Exercise Stage of Change
Pre-contemplation
1 Participants3 Participants4 Participants
Exercise Stage of Change
Preparation
70 Participants64 Participants134 Participants
Family Income
<$50,000
54 Participants45 Participants99 Participants
Family Income
≥$50,000
29 Participants32 Participants61 Participants
Generation Status
First
7 Participants6 Participants13 Participants
Generation Status
Second
57 Participants53 Participants110 Participants
Generation Status
Third
19 Participants18 Participants37 Participants
Land use access - NEWS-Y3.01 units on a scale
STANDARD_DEVIATION 0.5
2.94 units on a scale
STANDARD_DEVIATION 0.5
2.98 units on a scale
STANDARD_DEVIATION 0.5
Land-use mix - NEWS-Y2.37 units on a scale
STANDARD_DEVIATION 0.81
2.47 units on a scale
STANDARD_DEVIATION 0.62
2.42 units on a scale
STANDARD_DEVIATION 0.73
Maternal Support for Exercise2.55 units on a scale
STANDARD_DEVIATION 0.64
2.46 units on a scale
STANDARD_DEVIATION 0.75
2.51 units on a scale
STANDARD_DEVIATION 0.69
Neighborhood aesthetics - NEWS-Y2.89 units on a scale
STANDARD_DEVIATION 0.73
2.74 units on a scale
STANDARD_DEVIATION 0.66
2.82 units on a scale
STANDARD_DEVIATION 0.7
Neighborhood Environment4.57 units on a scale
STANDARD_DEVIATION 1.4
4.96 units on a scale
STANDARD_DEVIATION 1.2
4.77 units on a scale
STANDARD_DEVIATION 1.3
Neighborhood Walkability - Street Connectivity2.84 units on a scale
STANDARD_DEVIATION 0.6
2.83 units on a scale
STANDARD_DEVIATION 0.6
2.83 units on a scale
STANDARD_DEVIATION 0.6
Number of children in home1.93 number of children
STANDARD_DEVIATION 1.2
2.01 number of children
STANDARD_DEVIATION 1.2
1.97 number of children
STANDARD_DEVIATION 1.2
Parent Education
At least some college
39 Participants35 Participants74 Participants
Parent Education
High school or less
44 Participants42 Participants86 Participants
Physical Activity Enjoyment5.03 units on a scale
STANDARD_DEVIATION 0.93
4.67 units on a scale
STANDARD_DEVIATION 0.92
4.86 units on a scale
STANDARD_DEVIATION 0.94
Primary Language
English more than Spanish
37 Participants47 Participants84 Participants
Primary Language
Mostly Spanish
6 Participants4 Participants10 Participants
Primary Language
Only English
9 Participants5 Participants14 Participants
Primary Language
Spanish and English equally
31 Participants21 Participants52 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
4 Participants8 Participants12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
43 Participants31 Participants74 Participants
Race (NIH/OMB)
White
33 Participants35 Participants68 Participants
Recreation Facilities - NEWS-Y2.21 units on a scale
STANDARD_DEVIATION 0.76
2.27 units on a scale
STANDARD_DEVIATION 0.68
2.24 units on a scale
STANDARD_DEVIATION 0.72
Residential Density - NEWS-Y109 units on a scale
STANDARD_DEVIATION 40.3
112 units on a scale
STANDARD_DEVIATION 39.1
111 units on a scale
STANDARD_DEVIATION 39.6
Safety from crime2.19 units on a scale
STANDARD_DEVIATION 0.75
2.26 units on a scale
STANDARD_DEVIATION 0.78
2.22 units on a scale
STANDARD_DEVIATION 0.76
Safety from traffic - NEWS-Y2.79 units on a scale
STANDARD_DEVIATION 0.45
2.78 units on a scale
STANDARD_DEVIATION 0.45
2.78 units on a scale
STANDARD_DEVIATION 0.45
Self-Efficacy for Physical Activity2.03 units on a scale
STANDARD_DEVIATION 0.46
1.98 units on a scale
STANDARD_DEVIATION 0.54
2.01 units on a scale
STANDARD_DEVIATION 0.5
Self-Reported Physical Activity120 minutes of activity119 minutes of activity120 minutes of activity
Sex: Female, Male
Female
83 Participants77 Participants160 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Social Support for Exercise24.2 units on a scale
STANDARD_DEVIATION 16.7
20.5 units on a scale
STANDARD_DEVIATION 13.4
22.4 units on a scale
STANDARD_DEVIATION 15.3
Walking/cycling facilities - NEWS-Y3.05 units on a scale
STANDARD_DEVIATION 0.66
3.07 units on a scale
STANDARD_DEVIATION 0.59
3.06 units on a scale
STANDARD_DEVIATION 0.63

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 770 / 83
other
Total, other adverse events
0 / 770 / 83
serious
Total, serious adverse events
0 / 770 / 83

Outcome results

Primary

Objectively Measured Weekly Minutes of Activity

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

Time frame: Baseline, 6 Months (MO)

ArmMeasureValue (MEDIAN)
Multi-technology Physical Activity InterventionObjectively Measured Weekly Minutes of Activity64 weekly minutes of activity
ControlObjectively Measured Weekly Minutes of Activity41 weekly minutes of activity
p-value: 0.0495% CI: [4.67, 37.28]quantile regression
Primary

Self-Reported Weekly Minutes of Activity

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.

Time frame: Baseline, 6 Months (MO)

ArmMeasureValue (MEDIAN)
Multi-technology Physical Activity InterventionSelf-Reported Weekly Minutes of Activity147 minutes of activity per week
ControlSelf-Reported Weekly Minutes of Activity124 minutes of activity per week
p-value: 0.0395% CI: [8.35, 32.76]quantile regression
Secondary

Objectively Measured Weekly Minutes Minutes of Activity

weekly minutes of moderate-to-vigorous physical activity measured by ActiGraph accelerometer

Time frame: 12 months

ArmMeasureValue (MEDIAN)
Multi-technology Physical Activity InterventionObjectively Measured Weekly Minutes Minutes of Activity74 weekly minutes of activity
ControlObjectively Measured Weekly Minutes Minutes of Activity37 weekly minutes of activity
p-value: <0.001quantile regression

Source: ClinicalTrials.gov · Data processed: May 31, 2026