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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR017876 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Brown University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-technology physical activity intervention | Experimental | Digital/social media |
|
| Control | No Intervention | Control group receives a Fitbit but none of the intervention components. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital/social media intervention | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 6 Months (MO) |
| 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. | Baseline, 6 Months (MO) |
| Measure | Description | Time Frame |
|---|---|---|
| Objectively Measured Weekly Minutes Minutes of Activity | weekly minutes of moderate-to-vigorous physical activity measured by ActiGraph accelerometer | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Britta Larsen, PhD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42215952 | Derived | Castro E, Carson J, Greenstadt E, Olivera B, Dunsiger S, Higgins M, Godino J, Marcus B, Meyer D, Zive M, Larsen B. Maintenance of physical activity gains among Latina teens: 12-month findings from the Chicas Fuertes randomized controlled trial. Int J Behav Nutr Phys Act. 2026 May 29. doi: 10.1186/s12966-026-01933-w. Online ahead of print. | |
| 35197106 | Derived | Larsen B, Greenstadt E, Olesen B, Osuna L, Godino J, Marcus B, Dunsiger S, Meyer D, Zive M. A multiple technology-based physical activity intervention for Latina adolescents in the USA: randomized controlled trial study protocol for Chicas Fuertes. Trials. 2022 Feb 23;23(1):176. doi: 10.1186/s13063-022-06105-2. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Control | Control group receives a Fitbit but none of the intervention components. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | weekly minutes of activity | Baseline, 6 Months (MO) |
|
6 months
Participants were asked to alert the study team of any injuries or adverse events experienced during the trial within 24 hours of experiencing them
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shira Dunsiger, Biostatistician | Brown University | 401-863-6747 | shira_dunsiger@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2024 | Mar 19, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 18, 2022 | May 31, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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1:1 treatment: control
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| Unrelated health condition |
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| Control |
Control group receives a Fitbit but none of the intervention components. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Primary Language | Count of Participants | Participants |
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| Generation Status | Count of Participants | Participants |
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| Parent Education | Count of Participants | Participants |
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| Family Income | Count of Participants | Participants |
|
| Number of children in home | Mean | Standard Deviation | number of children |
|
| Neighborhood Walkability - Street Connectivity | The Street Connectivity sub-scale of the Neighborhood Environment Walkability Scale for Youth (NEWS-Y) has 3 items rated 1-4 (agree/disagree). Scores are averaged, with higher scores indicating higher perceived street connectivity. | Mean | Standard Deviation | units on a scale |
|
| Neighborhood Environment | The Physical Activity Neighborhood Environment scale (PANES) is an 8-item measure used to measure neighborhood walkability. Scoring ranges from 0-6, with higher numbers indicating higher walkability. | Mean | Standard Deviation | units on a scale |
|
| Physical Activity Enjoyment | The Physical Activity Enjoyment Scale (PACES) consists of 18 items rated on a 7-point Likert scale, and it measures enjoyment of physical activity. The total scoring range is 18-126. Results reported are an average score across the 18 items (1-7 range), with higher scores indicating greater enjoyment. | Mean | Standard Deviation | units on a scale |
|
| Depressive Symptoms | Depressive Symptoms were measured using the Center for Epidemiologic Studies Depression Scale (CES-D-10), a 10-item scale with response options ranging from "rarely or none of the time" (0) to "all of the time" (3). Total scores can range from 0 to 30, with a higher score indicating greater presence of depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Self-Efficacy for Physical Activity | This 5-item instrument measures self efficacy to exercise when facing various barriers to exercise. There are 4 response options ranging from "Not at all confident" to "Very confident." Total scoring range is from 5-20, with an average taken across the 5 items resulting in an average score of 1-4. Higher numbers indicate higher self efficacy. | Mean | Standard Deviation | units on a scale |
|
| Social Support for Exercise | The Social Support for Exercise scale (SSE) is frequently used among Hispanic populations. The 13-item survey is comprised of statements, which participants rate on a 1-5 Likert scale, with a scoring range from 13-65. A higher score indicates higher levels of social support for exercise. | Mean | Standard Deviation | units on a scale |
|
| Maternal Support for Exercise | The 26-item Maternal Support for Exercise questionnaire is administered to Latina mother-daughter dyads. The mothers' version rates how often they engaged in behaviors supporting their daughters' physical activity, and the daughters' version rates how often their mothers' engaged in these aforementioned behaviors. Each of the 26 items is rated using a 5-point Likert response option ranging from 1 = never to 5 = always/daily. Associations between mother and daughter dyads' scores are calculated, with higher scores indicating higher maternal support. | Mean | Standard Deviation | units on a scale |
|
| Exercise Stage of Change | Count of Participants | Participants |
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| ActiGraph Physical Activity | Median | Inter-Quartile Range | minutes of activity |
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| Self-Reported Physical Activity | Median | Inter-Quartile Range | minutes of activity |
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| Daily Steps | Mean | Standard Deviation | average daily steps across one week |
|
| Land-use mix - NEWS-Y | The Land Use Mix sub-scale of the Neighborhood Environment Walkability Scale for Youth (NEWS-Y) has 20 items listing businesses in the neighborhood, each of which is rated for walking distance (1 = 5 minutes, 5 = 30+ minutes). Scores are reverse coded and averaged, with higher scores indicating higher walkability. | Mean | Standard Deviation | units on a scale |
|
| Recreation Facilities - NEWS-Y | the recreation facilities sub-scale of the Neighborhood Environment Walkability Scale for Youth (NEWS-Y) includes 14 recreation facilities which are rated 1-5 for walking proximity (1 = 5 minutes, 5 = 30+ minutes). Scores are reverse coded and averaged, with higher scores indicating higher walkability. | Mean | Standard Deviation | units on a scale |
|
| Residential Density - NEWS-Y | The Residential Density sub-scale of the Neighborhood Environment Walkability Scale for Youth (NEWS-Y) has 4 items describing types of housing, which are rated 1-5 for perceived commonness in their neighborhood (1 = none, 5 = all). Scores are weighted and summed, with totals ranging from 40 to 200. Higher scores indicate higher walkability. | Mean | Standard Deviation | units on a scale |
|
| Land use access - NEWS-Y | The land use access sub-scale of the Neighborhood Environment Walkability Scale for Youth (NEWS-Y) has 6 items describing walkability in the participant's neighborhood, which are rated from 1 (disagree) to 4 (agree). Scores are averaged, with higher scores indicating higher walkability. | Mean | Standard Deviation | units on a scale |
|
| Walking/cycling facilities - NEWS-Y | The walking/cycling facilities sub-scale of the Neighborhood Environment Walkability Scale for Youth (NEWS-Y) has 3 items describing facilities to walk or bike within the participant's neighborhood. Items are rated from 1 (disagree) to 4 (agree). Scores are averaged, with higher scores indicating greater walkability. | Mean | Standard Deviation | units on a scale |
|
| Neighborhood aesthetics - NEWS-Y | The neighborhood aesthetics sub-scale of the Neighborhood Environment Walkability Scale for Youth (NEWS-Y) has 4 items describing aesthetic elements of the participant's neighborhood. Items are rated from 1 (disagree) to 4(agree). Scores are averaged, with higher scores indicating better aesthetics and higher walkability. | Mean | Standard Deviation | units on a scale |
|
| Safety from traffic - NEWS-Y | The safety from traffic sub-scale of the Neighborhood Environment Walkability Scale for Youth (NEWS-Y) has 7 items describing pedestrian and automobile traffic safety in the participant's neighborhood. Items are rated from 1 (disagree) to 4 (agree). Scores are averaged, with higher scores indicating lower safety and lower walkability. | Mean | Standard Deviation | units on a scale |
|
| Safety from crime | The safety from crime sub-scale of the Neighborhood Environment Walkability Scale for Youth (NEWS-Y) has 6 items describing crime in the participant's neighborhood. Items are rated from 1 (disagree) to 4 (agree). Scores are averaged, with higher scores indicating higher crime and lower walkability. | Mean | Standard Deviation | units on a scale |
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| 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. | Posted | Median | Inter-Quartile Range | minutes of activity per week | Baseline, 6 Months (MO) |
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| Secondary | Objectively Measured Weekly Minutes Minutes of Activity | weekly minutes of moderate-to-vigorous physical activity measured by ActiGraph accelerometer | Posted | Median | Inter-Quartile Range | weekly minutes of activity | 12 months |
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| 0 |
| 77 |
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | Control | Control group receives a Fitbit but none of the intervention components. | 0 | 83 | 0 | 83 | 0 | 83 |
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