ObesityNCT03986190

Healthy Juntos Pilot Study

A study testing Healthy Juntos in people with Obesity and Activity, Motor, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: Obesity, Activity, Motor, Diet, Healthy
What is being tested?: Healthy Juntos
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 27 Aug 2021to 6 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Female and male adolescents whose primary caregiver self-identifies as Hispanic
Adolescent is between the ages of 12-15;
Adolescent lives with an adult primary caregiver willing to participate;
Both parent and adolescent have smartphone/mobile device with internet access;
Adolescent does not meet recommendations for fruit and vegetable intake (proxy for overall diet quality) as determined by a validated two-item screener;
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.

Who cannot join

Adolescent's body mass index for age and gender is ≥ 95th percentile ("obese" range);
Adolescent has a chronic medical condition (e.g., type 2 diabetes) that requires intensive lifestyle modification;
Adolescent has a diagnosed developmental delay that would interfere with understanding program materials;
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);
Family is planning to move out of the South Florida during the study follow-up period

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents

Conditions: Obesity, Activity, Motor, Diet, Healthy, Sedentary Behavior
Being tested: Healthy Juntos
Keywords: Hispanic, family, digital health, obesity prevention, physical activity, nutrition
Medical subject headings: Obesity, Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Healthy JuntosBehavioural
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.

Study groups in NCT03986190
Study group	Role	What they receive
Healthy Juntos Intervention Condition	Experimental	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. Receives: Behavioral: Healthy Juntos
Control Group	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Adolescents Physical Activity
Adolescents will self-report physical activity using the Youth Activity Profile.
Measured: Baseline, up to 2 months
Change in Adolescent Sedentary Behavior
Adolescents will self-report sedentary behavior using the Youth Activity Profile.
Measured: Baseline, 2 months
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.
Measured: Baseline, 2 months
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.
Measured: Baseline, up to 2 months

Secondary outcomes (4)

Change in Parent Physical Activity.
Parents will self-report physical activity using the International Physical Activity Questionnaire.
Measured: Baseline, up to 2 months
Change Parent Sedentary Behavior
Parents will self-report their sitting time using a single item from the International Physical Activity Questionnaire
Measured: Baseline, up to 2 months
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.
Measured: Baseline, up to 2 months
Change in Parents Dietary Intake (Sugar)
Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.
Measured: Baseline, up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 20216 May 2023

First posted14 Jun 2019
Study start27 Aug 2021
Primary completion6 May 2023
Study completion6 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03986190
Sponsor's protocol ID: 20160415
Other IDs: K01HL133521
Status last verified: Jun 2024
First submitted: 11 Jun 2019
Last updated: 11 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents
ClinicalTrials.gov ID: NCT03986190
Acronym / sponsor ID: 20160415
Conditions: Obesity, Activity, Motor, Diet, Healthy, Sedentary Behavior
Keywords: Hispanic, family, digital health, obesity prevention, physical activity, nutrition
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 27 Aug 2021 (actual)
Primary completion: 6 May 2023 (actual)
Study completion: 6 May 2023 (actual)
First posted: 14 Jun 2019 (actual)
Results: Posted 11 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Healthy Juntos Intervention Condition	Experimental	Behavioral: Healthy JuntosParent-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.
Control Group	No intervention	–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.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Female and male adolescents whose primary caregiver self-identifies as Hispanic
Adolescent is between the ages of 12-15;
Adolescent lives with an adult primary caregiver willing to participate;
Both parent and adolescent have smartphone/mobile device with internet access;
Adolescent does not meet recommendations for fruit and vegetable intake (proxy for overall diet quality) as determined by a validated two-item screener;

Key exclusion criteria (5 listed)

Adolescent's body mass index for age and gender is ≥ 95th percentile ("obese" range);
Adolescent has a chronic medical condition (e.g., type 2 diabetes) that requires intensive lifestyle modification;
Adolescent has a diagnosed developmental delay that would interfere with understanding program materials;
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);
Family is planning to move out of the South Florida during the study follow-up period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Healthy JuntosParent-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.	Behavioural	Healthy Juntos Intervention Condition

Primary outcome

Change in Adolescents Physical Activity
Time frame: Baseline, up to 2 months
Adolescents will self-report physical activity using the Youth Activity Profile.
Change in Adolescent Sedentary Behavior
Time frame: Baseline, 2 months
Adolescents will self-report sedentary behavior using the Youth Activity Profile.
Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables)
Time frame: 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.
Change in Adolescents Dietary Intake (Sugar)
Time frame: Baseline, up to 2 months
Adolescent-parent dyads will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.

4 secondary outcomes

Change in Parent Physical Activity.
Time frame: Baseline, up to 2 months
Change Parent Sedentary Behavior
Time frame: Baseline, up to 2 months
Change in Parents Dietary Intake (i.e., Fruits/Vegetables)
Time frame: Baseline, up to 2 months
Change in Parents Dietary Intake (Sugar)
Time frame: Baseline, up to 2 months

Results and safety

Results posted to the registry on 11 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Juntos Intervention Condition	50	38
Control Group	50	50

Primary outcome: Change in Adolescents Physical Activity

Time frame: Baseline, up to 2 months. Mean (Standard Deviation). Unit: minutes/day

Measure	Healthy Juntos Intervention Condition n = 19	Control Group n = 25
MVPA out-of school	0.62 (1.31)	-0.13 (1.49)
MVPA at school	-0.18 (1.96)	-0.05 (1.06)
MVPA during the weekend	5.29 (8.04)	-2.40 (15.77)

Population analysed: Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off of participants.

Primary outcome: Change in Adolescent Sedentary Behavior

Time frame: Baseline, 2 months. Mean (Standard Deviation). Unit: minutes/day

Measure	Healthy Juntos Intervention Condition n = 19	Control Group n = 25
Value	-0.35 (11.25)	-3.08 (13.61)

Population analysed: Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off.

Primary outcome: Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables)

Time frame: Baseline, 2 months. Mean (Standard Deviation). Unit: cups/day

Measure	Healthy Juntos Intervention Condition n = 19	Control Group n = 25
Vegetables intake including legumes and no fries	0.33 (0.99)	-0.17 (0.85)
Fruit intake	0.13 (1.06)	-0.16 (0.73)

Population analysed: Analyzed number corresponds to those that completed measurements. Number is lower due to drop-off from baseline to T2 assessment.

Primary outcome: Change in Adolescents Dietary Intake (Sugar)

Time frame: Baseline, up to 2 months. Mean (Standard Deviation). Unit: Teaspoon per day

Measure	Healthy Juntos Intervention Condition n = 19	Control Group n = 25
Value	1.91 (9.46)	1.53 (7.50)

Population analysed: Difference at control group is due to lost of follow-up.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Juntos Intervention Condition	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Control Group	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sara M St George, PhD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Juntos in people with Obesity and Activity, Motor, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Adolescents Physical Activity (time frame: Baseline, up to 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03986190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.