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Completed

NCT Number: NCT03986190

Healthy Juntos Pilot Study

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Healthy Juntos

Behavioral

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.

Primary outcomes

  1. Change in Adolescents Physical Activity

    Time frame: Baseline, up to 2 months

    Adolescents will self-report physical activity using the Youth Activity Profile.

  2. Change in Adolescent Sedentary Behavior

    Time frame: Baseline, 2 months

    Adolescents will self-report sedentary behavior using the Youth Activity Profile.

  3. 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.

  4. 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.

Secondary outcomes

  1. Change in Parent Physical Activity.

    Time frame: Baseline, up to 2 months

    Parents will self-report physical activity using the International Physical Activity Questionnaire.

  2. Change Parent Sedentary Behavior

    Time frame: Baseline, up to 2 months

    Parents will self-report their sitting time using a single item from the International Physical Activity Questionnaire

  3. Change in Parents Dietary Intake (i.e., Fruits/Vegetables)

    Time frame: 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.

  4. Change in Parents Dietary Intake (Sugar)

    Time frame: Baseline, up to 2 months

    Parents will self-report dietary intake using the NHANES Dietary Screener Questionnaire. Teaspoon equivalents of added sugars.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2019
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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