Physical Activity
Conditions
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
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
Study design
Intervention model description
1:1 treatment: control
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Objectively Measured Weekly Minutes of Activity | 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 |
| Self-Reported Weekly Minutes of Activity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objectively Measured Weekly Minutes Minutes of Activity | 12 months | weekly 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
| Arm | Count |
|---|---|
| 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 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Unrelated health condition | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Control | Multi-technology Physical Activity Intervention | Total |
|---|---|---|---|
| ActiGraph Physical Activity | 0 minutes of activity | 0 minutes of activity | 0 minutes of activity |
| Age, Continuous | 15.9 years STANDARD_DEVIATION 1.5 | 15.8 years STANDARD_DEVIATION 1.7 | 15.9 years STANDARD_DEVIATION 1.3 |
| Body Mass Index | 25.2 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 Steps | 5275 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 Symptoms | 11.14 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 Participants | 77 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Exercise Stage of Change Contemplation | 12 Participants | 10 Participants | 22 Participants |
| Exercise Stage of Change Pre-contemplation | 1 Participants | 3 Participants | 4 Participants |
| Exercise Stage of Change Preparation | 70 Participants | 64 Participants | 134 Participants |
| Family Income <$50,000 | 54 Participants | 45 Participants | 99 Participants |
| Family Income ≥$50,000 | 29 Participants | 32 Participants | 61 Participants |
| Generation Status First | 7 Participants | 6 Participants | 13 Participants |
| Generation Status Second | 57 Participants | 53 Participants | 110 Participants |
| Generation Status Third | 19 Participants | 18 Participants | 37 Participants |
| Land use access - NEWS-Y | 3.01 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-Y | 2.37 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 Exercise | 2.55 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-Y | 2.89 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 Environment | 4.57 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 Connectivity | 2.84 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 home | 1.93 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 Participants | 35 Participants | 74 Participants |
| Parent Education High school or less | 44 Participants | 42 Participants | 86 Participants |
| Physical Activity Enjoyment | 5.03 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 Participants | 47 Participants | 84 Participants |
| Primary Language Mostly Spanish | 6 Participants | 4 Participants | 10 Participants |
| Primary Language Only English | 9 Participants | 5 Participants | 14 Participants |
| Primary Language Spanish and English equally | 31 Participants | 21 Participants | 52 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 43 Participants | 31 Participants | 74 Participants |
| Race (NIH/OMB) White | 33 Participants | 35 Participants | 68 Participants |
| Recreation Facilities - NEWS-Y | 2.21 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-Y | 109 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 crime | 2.19 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-Y | 2.79 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 Activity | 2.03 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 Activity | 120 minutes of activity | 119 minutes of activity | 120 minutes of activity |
| Sex: Female, Male Female | 83 Participants | 77 Participants | 160 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Social Support for Exercise | 24.2 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-Y | 3.05 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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 83 |
| other Total, other adverse events | 0 / 77 | 0 / 83 |
| serious Total, serious adverse events | 0 / 77 | 0 / 83 |
Outcome results
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Multi-technology Physical Activity Intervention | Objectively Measured Weekly Minutes of Activity | 64 weekly minutes of activity |
| Control | Objectively Measured Weekly Minutes of Activity | 41 weekly minutes of activity |
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Multi-technology Physical Activity Intervention | Self-Reported Weekly Minutes of Activity | 147 minutes of activity per week |
| Control | Self-Reported Weekly Minutes of Activity | 124 minutes of activity per week |
Objectively Measured Weekly Minutes Minutes of Activity
weekly minutes of moderate-to-vigorous physical activity measured by ActiGraph accelerometer
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Multi-technology Physical Activity Intervention | Objectively Measured Weekly Minutes Minutes of Activity | 74 weekly minutes of activity |
| Control | Objectively Measured Weekly Minutes Minutes of Activity | 37 weekly minutes of activity |