Trial Outcomes & Findings for Healthy Juntos Pilot Study (NCT NCT03986190)
NCT ID: NCT03986190
Last Updated: 2024-06-11
Results Overview
Adolescents will self-report physical activity using the Youth Activity Profile.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Baseline, up to 2 months
Results posted on
2024-06-11
Participant Flow
50 parent-adolescent dyads were enrolled and randomized.
Participant milestones
| Measure |
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.
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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.
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|---|---|---|
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Overall Study
STARTED
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50
|
50
|
|
Overall Study
Adolescents Started
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25
|
25
|
|
Overall Study
Parents Started
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25
|
25
|
|
Overall Study
Adolescents Completed
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19
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25
|
|
Overall Study
Parents Completed
|
19
|
25
|
|
Overall Study
COMPLETED
|
38
|
50
|
|
Overall Study
NOT COMPLETED
|
12
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
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0
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Baseline Characteristics
A total of 50 participants were included in each arm. Given the nature of the intervention being dyadic we have included 25 parents and 25 adolescents for each group to provide each group's age.
Baseline characteristics by cohort
| Measure |
Healthy Juntos Intervention Condition
n=50 Participants
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.
|
Control Group
n=50 Participants
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.
|
Total
n=100 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
Adolescents
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13.70 years
STANDARD_DEVIATION 1.02 • n=25 Participants • A total of 50 participants were included in each arm. Given the nature of the intervention being dyadic we have included 25 parents and 25 adolescents for each group to provide each group's age.
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14 years
STANDARD_DEVIATION 1.21 • n=25 Participants • A total of 50 participants were included in each arm. Given the nature of the intervention being dyadic we have included 25 parents and 25 adolescents for each group to provide each group's age.
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13.80 years
STANDARD_DEVIATION 1.11 • n=50 Participants • A total of 50 participants were included in each arm. Given the nature of the intervention being dyadic we have included 25 parents and 25 adolescents for each group to provide each group's age.
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|
Age, Customized
Parents
|
41.90 years
STANDARD_DEVIATION 7.54 • n=25 Participants • A total of 50 participants were included in each arm. Given the nature of the intervention being dyadic we have included 25 parents and 25 adolescents for each group to provide each group's age.
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43.90 years
STANDARD_DEVIATION 6.25 • n=25 Participants • A total of 50 participants were included in each arm. Given the nature of the intervention being dyadic we have included 25 parents and 25 adolescents for each group to provide each group's age.
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42.90 years
STANDARD_DEVIATION 6.92 • n=50 Participants • A total of 50 participants were included in each arm. Given the nature of the intervention being dyadic we have included 25 parents and 25 adolescents for each group to provide each group's age.
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|
Sex/Gender, Customized
Adolescents · Male
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13 Participants
n=25 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
12 Participants
n=25 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
25 Participants
n=50 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
|
Sex/Gender, Customized
Adolescents · Female
|
12 Participants
n=25 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
13 Participants
n=25 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
25 Participants
n=50 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
|
Sex/Gender, Customized
Parents · Male
|
2 Participants
n=25 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
4 Participants
n=25 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
6 Participants
n=50 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
|
Sex/Gender, Customized
Parents · Female
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23 Participants
n=25 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
21 Participants
n=25 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
|
44 Participants
n=50 Participants • A total of 50 participants were included in each arm. Because the study enrolled dyads, comprised of one parent and one adolescent, we enrolled 25 parents and 25 adolescents into each group and summarized sex/gender separately for parents and adolescents.
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Ethnicity (NIH/OMB)
Hispanic or Latino
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50 Participants
n=50 Participants
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50 Participants
n=50 Participants
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100 Participants
n=100 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=50 Participants
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0 Participants
n=50 Participants
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0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=50 Participants
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0 Participants
n=50 Participants
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0 Participants
n=100 Participants
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Physical Activity
Adolescents MVPA out-of school
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13.20 Minutes/day
STANDARD_DEVIATION 1.94 • n=25 Participants • Results are displayed separately for parents and adolescents.
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12.72 Minutes/day
STANDARD_DEVIATION 1.84 • n=25 Participants • Results are displayed separately for parents and adolescents.
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12.96 Minutes/day
STANDARD_DEVIATION 1.88 • n=50 Participants • Results are displayed separately for parents and adolescents.
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|
Physical Activity
Adolescents MVPA at school
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12.13 Minutes/day
STANDARD_DEVIATION 1.50 • n=25 Participants • Results are displayed separately for parents and adolescents.
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12.35 Minutes/day
STANDARD_DEVIATION 1.86 • n=25 Participants • Results are displayed separately for parents and adolescents.
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12.24 Minutes/day
STANDARD_DEVIATION 1.68 • n=50 Participants • Results are displayed separately for parents and adolescents.
|
|
Physical Activity
Adolescents MVPA during the weekend
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10.89 Minutes/day
STANDARD_DEVIATION 1.31 • n=25 Participants • Results are displayed separately for parents and adolescents.
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11.17 Minutes/day
STANDARD_DEVIATION 1.53 • n=25 Participants • Results are displayed separately for parents and adolescents.
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11.03 Minutes/day
STANDARD_DEVIATION 1.42 • n=50 Participants • Results are displayed separately for parents and adolescents.
|
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Physical Activity
Parents MVPA
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56.88 Minutes/day
STANDARD_DEVIATION 64.70 • n=25 Participants • Results are displayed separately for parents and adolescents.
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57.83 Minutes/day
STANDARD_DEVIATION 59.56 • n=25 Participants • Results are displayed separately for parents and adolescents.
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57.34 Minutes/day
STANDARD_DEVIATION 61.56 • n=50 Participants • Results are displayed separately for parents and adolescents.
|
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Fruit and Vegetable Intake
Adolescents vegetables intake including legumes and no fries
|
1.11 cups/day
STANDARD_DEVIATION 0.43 • n=25 Participants • Results are displayed by separately for parents and adolescents.
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1.10 cups/day
STANDARD_DEVIATION 0.4 • n=25 Participants • Results are displayed by separately for parents and adolescents.
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1.10 cups/day
STANDARD_DEVIATION 0.41 • n=50 Participants • Results are displayed by separately for parents and adolescents.
|
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Fruit and Vegetable Intake
Adolescents fruit intake
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0.85 cups/day
STANDARD_DEVIATION 0.76 • n=25 Participants • Results are displayed by separately for parents and adolescents.
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0.93 cups/day
STANDARD_DEVIATION 0.69 • n=25 Participants • Results are displayed by separately for parents and adolescents.
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0.89 cups/day
STANDARD_DEVIATION 0.72 • n=50 Participants • Results are displayed by separately for parents and adolescents.
|
|
Fruit and Vegetable Intake
Parents vegetables intake including legumes and no fries
|
1.32 cups/day
STANDARD_DEVIATION 0.38 • n=25 Participants • Results are displayed by separately for parents and adolescents.
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1.33 cups/day
STANDARD_DEVIATION 0.46 • n=25 Participants • Results are displayed by separately for parents and adolescents.
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1.33 cups/day
STANDARD_DEVIATION 0.42 • n=50 Participants • Results are displayed by separately for parents and adolescents.
|
|
Fruit and Vegetable Intake
Parents fruit intake
|
0.75 cups/day
STANDARD_DEVIATION 0.28 • n=25 Participants • Results are displayed by separately for parents and adolescents.
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0.77 cups/day
STANDARD_DEVIATION 0.30 • n=25 Participants • Results are displayed by separately for parents and adolescents.
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0.76 cups/day
STANDARD_DEVIATION 0.29 • n=50 Participants • Results are displayed by separately for parents and adolescents.
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Adolescents Sedentary Behavior Out-of-school
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58.73 Minutes/day
STANDARD_DEVIATION 2.20 • n=25 Participants • Results are displayed separately for parents and adolescents.
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58.11 Minutes/day
STANDARD_DEVIATION 2.82 • n=25 Participants • Results are displayed separately for parents and adolescents.
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58.42 Minutes/day
STANDARD_DEVIATION 2.52 • n=50 Participants • Results are displayed separately for parents and adolescents.
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Parents Sedentary Behavior
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4.28 Sitting hours/day
STANDARD_DEVIATION 2.95 • n=25 Participants • Results are displayed separately for parents and adolescents
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3.26 Sitting hours/day
STANDARD_DEVIATION 2.37 • n=25 Participants • Results are displayed separately for parents and adolescents
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3.78 Sitting hours/day
STANDARD_DEVIATION 2.70 • n=50 Participants • Results are displayed separately for parents and adolescents
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PRIMARY outcome
Timeframe: Baseline, up to 2 monthsPopulation: Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off of participants.
Adolescents will self-report physical activity using the Youth Activity Profile.
Outcome measures
| Measure |
Healthy Juntos Intervention Condition
n=19 Participants
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.
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change in Adolescents Physical Activity
MVPA out-of school
|
0.62 minutes/day
Standard Deviation 1.31
|
-0.13 minutes/day
Standard Deviation 1.49
|
|
Change in Adolescents Physical Activity
MVPA at school
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-0.18 minutes/day
Standard Deviation 1.96
|
-0.05 minutes/day
Standard Deviation 1.06
|
|
Change in Adolescents Physical Activity
MVPA during the weekend
|
5.29 minutes/day
Standard Deviation 8.04
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-2.40 minutes/day
Standard Deviation 15.77
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PRIMARY outcome
Timeframe: Baseline, 2 monthsPopulation: Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off.
Adolescents will self-report sedentary behavior using the Youth Activity Profile.
Outcome measures
| Measure |
Healthy Juntos Intervention Condition
n=19 Participants
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.
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change in Adolescent Sedentary Behavior
|
-0.35 minutes/day
Standard Deviation 11.25
|
-3.08 minutes/day
Standard Deviation 13.61
|
PRIMARY outcome
Timeframe: Baseline, 2 monthsPopulation: Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off from baseline to T2 assessment.
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.
Outcome measures
| Measure |
Healthy Juntos Intervention Condition
n=19 Participants
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.
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables)
Vegetables intake including legumes and no fries
|
0.33 cups/day
Standard Deviation 0.99
|
-0.17 cups/day
Standard Deviation 0.85
|
|
Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables)
Fruit intake
|
0.13 cups/day
Standard Deviation 1.06
|
-0.16 cups/day
Standard Deviation 0.73
|
PRIMARY outcome
Timeframe: Baseline, up to 2 monthsPopulation: Difference at control group is due to lost of follow-up.
Adolescent-parent dyads will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.
Outcome measures
| Measure |
Healthy Juntos Intervention Condition
n=19 Participants
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.
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change in Adolescents Dietary Intake (Sugar)
|
1.91 Teaspoon per day
Standard Deviation 9.46
|
1.53 Teaspoon per day
Standard Deviation 7.50
|
SECONDARY outcome
Timeframe: Baseline, up to 2 monthsParents will self-report physical activity using the International Physical Activity Questionnaire.
Outcome measures
| Measure |
Healthy Juntos Intervention Condition
n=18 Participants
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.
|
Control Group
n=23 Participants
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.
|
|---|---|---|
|
Change in Parent Physical Activity.
|
38.82 minutes/day
Standard Deviation 60.01
|
38.26 minutes/day
Standard Deviation 75.49
|
SECONDARY outcome
Timeframe: Baseline, up to 2 monthsParents will self-report their sitting time using a single item from the International Physical Activity Questionnaire
Outcome measures
| Measure |
Healthy Juntos Intervention Condition
n=18 Participants
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.
|
Control Group
n=23 Participants
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.
|
|---|---|---|
|
Change Parent Sedentary Behavior
|
-0.04 sitting hours/day
Standard Deviation 1.92
|
0.34 sitting hours/day
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Baseline, up to 2 monthsPopulation: Difference is total numbers due to drop-off.
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.
Outcome measures
| Measure |
Healthy Juntos Intervention Condition
n=19 Participants
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.
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change in Parents Dietary Intake (i.e., Fruits/Vegetables)
Vegetables intake including legumes and no fries
|
0.21 cups/day
Standard Deviation 0.33
|
-0.02 cups/day
Standard Deviation 0.46
|
|
Change in Parents Dietary Intake (i.e., Fruits/Vegetables)
Fruit intake
|
0.06 cups/day
Standard Deviation 0.26
|
-0.01 cups/day
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Baseline, up to 2 monthsParents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.
Outcome measures
| Measure |
Healthy Juntos Intervention Condition
n=19 Participants
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.
|
Control Group
n=23 Participants
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.
|
|---|---|---|
|
Change in Parents Dietary Intake (Sugar)
|
-1.25 teaspoon/day
Standard Deviation 2.93
|
1.28 teaspoon/day
Standard Deviation 5.53
|
Adverse Events
Healthy Juntos Intervention Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Dr. Sara St George
University of Miami Miller School of Medicine
Phone: 305-243-0726
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place