Clinical trial NCT03986190: Healthy Juntos Pilot Study
Official title: Family-based eHealth Obesity Prevention Intervention for Hispanic Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Activity, Motor
Diet, Healthy
Sedentary Behavior
Keywords: Hispanic
family
digital health
obesity prevention
physical activity
nutrition
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Adolescents Physical Activity
timeFrame: Baseline, up to 2 months
measure: Change in Adolescent Sedentary Behavior
timeFrame: Baseline, 2 months
measure: Change in Adolescents Dietary Intake (i.e., Fruits/Vegetables)
timeFrame: Baseline, 2 months
measure: Change in Adolescents Dietary Intake (Sugar)
timeFrame: Baseline, up to 2 months
Secondary outcomes:
measure: Change in Parent Physical Activity.
timeFrame: Baseline, up to 2 months
measure: Change Parent Sedentary Behavior
timeFrame: Baseline, up to 2 months
measure: Change in Parents Dietary Intake (i.e., Fruits/Vegetables)
timeFrame: Baseline, up to 2 months
measure: Change in Parents Dietary Intake (Sugar)
timeFrame: Baseline, up to 2 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sara M St George, PhD
role: PRINCIPAL_INVESTIGATOR
References: