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Clinical Trials/NCT03986190
NCT03986190CompletedNot Applicable

Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents

University of Miami1 site in 1 country100 target enrollmentStarted: August 27, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Change in Adolescents Physical Activity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Healthy Juntos (Behavioral)

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.

Outcomes

Primary Outcomes

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 (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.

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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sara StGeorge

Assistant Professor of Public Health Sciences

University of Miami

Study Sites (1)

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