Activity, Motor, Diet, Healthy, Obesity, Sedentary Behavior
Conditions
Keywords
Hispanic, family, digital health, obesity prevention, physical activity, nutrition
Brief summary
The purpose of the study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile phone-based) program to improve physical activity levels and quality dietary intake among Hispanic parent-adolescent dyads.
Interventions
BEHAVIORALHealthy Juntos
Parent-adolescent dyads will log in to a secured website for a total of eight weeks. The intervention will be delivered primarily through smartphones and will include didactic content on healthy lifestyle behaviors (for parents/adolescents), family behavior change content for setting weekly goals and self-monitoring health behaviors (for parents/adolescents), and positive parenting content (for parents only), all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support (supportive accountability) will be provided. Specifically, each family will be assigned a coach who will use video conferencing software to engage in weekly 15-30 minute sessions regarding the family's progress throughout the intervention period.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Female and male adolescents whose primary caregiver self-identifies as Hispanic 2. Adolescent is between the ages of 12-15; 3. Adolescent lives with an adult primary caregiver willing to participate; 4. Both parent and adolescent have smartphone/mobile device with internet access; 5. Adolescent does not meet recommendations for fruit and vegetable intake (proxy for overall diet quality) as determined by a validated two-item screener; 6. Adolescent does not meet physical activity guidelines as determined by responses on a validated two-item screener AND self-reports engaging in \>2 hours/day of screen time (proxy for overall sedentary behavior) using three items.
Exclusion criteria
1. Adolescent's body mass index for age and gender is ≥ 95th percentile (obese range); 2. Adolescent has a chronic medical condition (e.g., type 2 diabetes) that requires intensive lifestyle modification; 3. Adolescent has a diagnosed developmental delay that would interfere with understanding program materials; 4. Parent or adolescent has a diagnosed medical or psychiatric condition and is currently taking medications that would interfere with changes to physical activity or diet (e.g., adolescent is diagnosed with Attention Deficit Hyperactivity Disorder and is currently on stimulant medication); 5. Family is planning to move out of the South Florida during the study follow-up period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adolescents Dietary Intake (Sugar) | Baseline, up to 2 months | Adolescent-parent dyads will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars. |
| Change in Adolescents Physical Activity | Baseline, up to 2 months | Adolescents will self-report physical activity using the Youth Activity Profile. |
| Change in Adolescent Sedentary Behavior | Baseline, 2 months | Adolescents will self-report sedentary behavior using the Youth Activity Profile. |
| Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables) | Baseline, 2 months | Adolescents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Parent Physical Activity. | Baseline, up to 2 months | Parents will self-report physical activity using the International Physical Activity Questionnaire. |
| Change Parent Sedentary Behavior | Baseline, up to 2 months | Parents will self-report their sitting time using a single item from the International Physical Activity Questionnaire |
| Change in Parents Dietary Intake (i.e., Fruits/Vegetables) | Baseline, up to 2 months | Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute. |
| Change in Parents Dietary Intake (Sugar) | Baseline, up to 2 months | Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars. |
Countries
United States
Participant flow
Pre-assignment details
50 parent-adolescent dyads were enrolled and randomized.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Juntos Intervention Condition Parent-adolescent dyads randomized to the Healthy Juntos intervention condition will access a program that includes didactic, behavioral, and positive parenting content from their smartphones for 8 weeks.
Healthy Juntos: Parent-adolescent dyads will log in to a secured website for a total of eight weeks. The intervention will be delivered primarily through smartphones and will include didactic content on healthy lifestyle behaviors (for parents/adolescents), family behavior change content for setting weekly goals and self-monitoring health behaviors (for parents/adolescents), and positive parenting content (for parents only), all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support (supportive accountability) will be provided. Specifically, each family will be assigned a coach who will use video conferencing software to engage in weekly 15-30 minute sessions regarding the family's progress throughout the intervention period. | 50 |
| Control Group This group will receive a digital standard of care - a list of publicly available lifestyle apps and websites which they may access at their discretion. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 12 | 0 |
Baseline characteristics
| Characteristic | Healthy Juntos Intervention Condition | Total | Control Group |
|---|---|---|---|
| Adolescents Sedentary Behavior Out-of-school | 58.73 Minutes/day STANDARD_DEVIATION 2.2 | 58.42 Minutes/day STANDARD_DEVIATION 2.52 | 58.11 Minutes/day STANDARD_DEVIATION 2.82 |
| Age, Customized Adolescents | 13.70 years STANDARD_DEVIATION 1.02 | 13.80 years STANDARD_DEVIATION 1.11 | 14 years STANDARD_DEVIATION 1.21 |
| Age, Customized Parents | 41.90 years STANDARD_DEVIATION 7.54 | 42.90 years STANDARD_DEVIATION 6.92 | 43.90 years STANDARD_DEVIATION 6.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants | 100 Participants | 50 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 |
| Fruit and Vegetable Intake Adolescents fruit intake | 0.85 cups/day STANDARD_DEVIATION 0.76 | 0.89 cups/day STANDARD_DEVIATION 0.72 | 0.93 cups/day STANDARD_DEVIATION 0.69 |
| Fruit and Vegetable Intake Adolescents vegetables intake including legumes and no fries | 1.11 cups/day STANDARD_DEVIATION 0.43 | 1.10 cups/day STANDARD_DEVIATION 0.41 | 1.10 cups/day STANDARD_DEVIATION 0.4 |
| Fruit and Vegetable Intake Parents fruit intake | 0.75 cups/day STANDARD_DEVIATION 0.28 | 0.76 cups/day STANDARD_DEVIATION 0.29 | 0.77 cups/day STANDARD_DEVIATION 0.3 |
| Fruit and Vegetable Intake Parents vegetables intake including legumes and no fries | 1.32 cups/day STANDARD_DEVIATION 0.38 | 1.33 cups/day STANDARD_DEVIATION 0.42 | 1.33 cups/day STANDARD_DEVIATION 0.46 |
| Parents Sedentary Behavior | 4.28 Sitting hours/day STANDARD_DEVIATION 2.95 | 3.78 Sitting hours/day STANDARD_DEVIATION 2.7 | 3.26 Sitting hours/day STANDARD_DEVIATION 2.37 |
| Physical Activity Adolescents MVPA at school | 12.13 Minutes/day STANDARD_DEVIATION 1.5 | 12.24 Minutes/day STANDARD_DEVIATION 1.68 | 12.35 Minutes/day STANDARD_DEVIATION 1.86 |
| Physical Activity Adolescents MVPA during the weekend | 10.89 Minutes/day STANDARD_DEVIATION 1.31 | 11.03 Minutes/day STANDARD_DEVIATION 1.42 | 11.17 Minutes/day STANDARD_DEVIATION 1.53 |
| Physical Activity Adolescents MVPA out-of school | 13.20 Minutes/day STANDARD_DEVIATION 1.94 | 12.96 Minutes/day STANDARD_DEVIATION 1.88 | 12.72 Minutes/day STANDARD_DEVIATION 1.84 |
| Physical Activity Parents MVPA | 56.88 Minutes/day STANDARD_DEVIATION 64.7 | 57.34 Minutes/day STANDARD_DEVIATION 61.56 | 57.83 Minutes/day STANDARD_DEVIATION 59.56 |
| Sex/Gender, Customized Adolescents Female | 12 Participants | 25 Participants | 13 Participants |
| Sex/Gender, Customized Adolescents Male | 13 Participants | 25 Participants | 12 Participants |
| Sex/Gender, Customized Parents Female | 23 Participants | 44 Participants | 21 Participants |
| Sex/Gender, Customized Parents Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables)
Adolescents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute.
Time frame: Baseline, 2 months
Population: Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off from baseline to T2 assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Juntos Intervention Condition | Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables) | Fruit intake | 0.13 cups/day | Standard Deviation 1.06 |
| Healthy Juntos Intervention Condition | Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables) | Vegetables intake including legumes and no fries | 0.33 cups/day | Standard Deviation 0.99 |
| Control Group | Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables) | Vegetables intake including legumes and no fries | -0.17 cups/day | Standard Deviation 0.85 |
| Control Group | Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables) | Fruit intake | -0.16 cups/day | Standard Deviation 0.73 |
Primary
Change in Adolescents Dietary Intake (Sugar)
Adolescent-parent dyads will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.
Time frame: Baseline, up to 2 months
Population: Difference at control group is due to lost of follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Juntos Intervention Condition | Change in Adolescents Dietary Intake (Sugar) | 1.91 Teaspoon per day | Standard Deviation 9.46 |
| Control Group | Change in Adolescents Dietary Intake (Sugar) | 1.53 Teaspoon per day | Standard Deviation 7.5 |
Primary
Change in Adolescent Sedentary Behavior
Adolescents will self-report sedentary behavior using the Youth Activity Profile.
Time frame: Baseline, 2 months
Population: Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Juntos Intervention Condition | Change in Adolescent Sedentary Behavior | -0.35 minutes/day | Standard Deviation 11.25 |
| Control Group | Change in Adolescent Sedentary Behavior | -3.08 minutes/day | Standard Deviation 13.61 |
Primary
Change in Adolescents Physical Activity
Adolescents will self-report physical activity using the Youth Activity Profile.
Time frame: Baseline, up to 2 months
Population: Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Juntos Intervention Condition | Change in Adolescents Physical Activity | MVPA out-of school | 0.62 minutes/day | Standard Deviation 1.31 |
| Healthy Juntos Intervention Condition | Change in Adolescents Physical Activity | MVPA at school | -0.18 minutes/day | Standard Deviation 1.96 |
| Healthy Juntos Intervention Condition | Change in Adolescents Physical Activity | MVPA during the weekend | 5.29 minutes/day | Standard Deviation 8.04 |
| Control Group | Change in Adolescents Physical Activity | MVPA out-of school | -0.13 minutes/day | Standard Deviation 1.49 |
| Control Group | Change in Adolescents Physical Activity | MVPA at school | -0.05 minutes/day | Standard Deviation 1.06 |
| Control Group | Change in Adolescents Physical Activity | MVPA during the weekend | -2.40 minutes/day | Standard Deviation 15.77 |
Secondary
Change in Parent Physical Activity.
Parents will self-report physical activity using the International Physical Activity Questionnaire.
Time frame: Baseline, up to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Juntos Intervention Condition | Change in Parent Physical Activity. | 38.82 minutes/day | Standard Deviation 60.01 |
| Control Group | Change in Parent Physical Activity. | 38.26 minutes/day | Standard Deviation 75.49 |
Secondary
Change in Parents Dietary Intake (i.e., Fruits/Vegetables)
Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute.
Time frame: Baseline, up to 2 months
Population: Difference is total numbers due to drop-off.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Juntos Intervention Condition | Change in Parents Dietary Intake (i.e., Fruits/Vegetables) | Fruit intake | 0.06 cups/day | Standard Deviation 0.26 |
| Healthy Juntos Intervention Condition | Change in Parents Dietary Intake (i.e., Fruits/Vegetables) | Vegetables intake including legumes and no fries | 0.21 cups/day | Standard Deviation 0.33 |
| Control Group | Change in Parents Dietary Intake (i.e., Fruits/Vegetables) | Vegetables intake including legumes and no fries | -0.02 cups/day | Standard Deviation 0.46 |
| Control Group | Change in Parents Dietary Intake (i.e., Fruits/Vegetables) | Fruit intake | -0.01 cups/day | Standard Deviation 0.38 |
Secondary
Change in Parents Dietary Intake (Sugar)
Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.
Time frame: Baseline, up to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Juntos Intervention Condition | Change in Parents Dietary Intake (Sugar) | -1.25 teaspoon/day | Standard Deviation 2.93 |
| Control Group | Change in Parents Dietary Intake (Sugar) | 1.28 teaspoon/day | Standard Deviation 5.53 |
Secondary
Change Parent Sedentary Behavior
Parents will self-report their sitting time using a single item from the International Physical Activity Questionnaire
Time frame: Baseline, up to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Juntos Intervention Condition | Change Parent Sedentary Behavior | -0.04 sitting hours/day | Standard Deviation 1.92 |
| Control Group | Change Parent Sedentary Behavior | 0.34 sitting hours/day | Standard Deviation 2.45 |