Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children
Hispanic men and children experience health disparities for overweight and obesity-related medical conditions, and therefore family level obesity prevention programs for Hispanic populations are needed. 'Healthy Dads Healthy Kids' is the first program to primarily target fathers for obesity prevention for themselves and their children, with significant and clinically relevant treatment effects. This is an efficacy trial to assess a culturally adapted 'Healthy Dads Healthy Kids' for Hispanic families.
Conditions:
🦠 Obesity 🦠 Obesity, Childhood 🦠 Physical Activity 🦠 Dietary Intake
🗓️ Study Start (Actual) 28 April 2022
🗓️ Primary Completion (Estimated) 1 March 2026
✅ Study Completion (Estimated) 31 August 2026
👥 Enrollment (Estimated) 216
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

  • FATHER
  • * Father or significant male role model (e.g. step father, grandfather, uncle, or older brother) of a child 5-11 years old
  • * Age 18-65 year old
  • * Living in Greater Houston Area
  • * Self-identify as Hispanic or Latino
  • * Able to read and write in Spanish or English
  • * BMI \>/=25 - 40
  • * Pass the 2015 American College of Sports Medicine's exercise participation health screener
  • CHILD • 5-11 year old child and up to three siblings, whose father/significant male role model is participating
  • MOTHER (If available) 1) Significant female role model such as biological mother, step mother, foster mother, grandmother, aunt or older sister; or other co-parent/partner to participating children

Exclusion Criteria:

  • FATHER
  • * Known diagnosis of diabetes without medical clearance from health care provider;
  • * Known diagnosis of cardio-vascular disease (cardiac arrhythmia, h/o myocardial infarction, heart valve disease, heat failure, heart transplantation, congenital heart disease, h/o heat surgery, coronary angioplasty, or stroke)
  • * Currently, or in the past 6 months, in a weight management program
  • * Currently, or in the past 6 months, taking medicine that can affect weight or might be affected by weight loss
  • * Any other disease or condition affecting their ability to participate in physical activities/exercise (e.g., physical disability, severe asthma)
  • * Any other disease or condition affecting their ability to participate in group classroom activities including cognitive impairment (e.g., Down's syndrome, Fragile X), or psychiatric functioning (e.g. schizophrenia)
  • * Plans of moving away from Harris County in the next year
  • * Not passing the 2015 American College of Sports Medicine's exercise participation health screener AND NOT provide a medical clearance from a licensed medical provider (MD, NNP, PA)
  • * Unwilling to wear accelerometer for a 7 day study period at the three assessment points.
  • * BMI less than 25 or greater than 40.
  • * HbgA1C equal or greater than 6.5% at baseline data collection without medical clearance from health care provider.
  • * Has previously participated in studies on the Healthy Dads Healthy Kids' for US Hispanics
  • * History of myocarditis from COVID infection or vaccine
  • CHILD
  • * Not within the 5-11 year old child age range
  • * Known diagnosis of diabetes
  • * Known diagnosis of cardio-vascular disease (cardiac arrhythmia, h/o myocardial infarction, heart valve disease, heat failure, heart transplantation, congenital heart disease, h/o heat surgery or coronary angioplasty)
  • * Inability to participate in regular physical education classes in school due to health or physical condition (e.g. physical disability, severe asthma)
  • * Any disease or condition affecting their ability to participate in group classroom activities including cognitive impairment (e.g. Down's syndrome, Fragile X), or developmental problems (e.g. autism)
  • MOTHER
  • • No father figure to her children enrolled in the study
Ages Eligible for Study: 5 Years to 65 Years (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 April 2022
  • First Submitted that Met QC Criteria 18 April 2022
  • First Posted 19 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 June 2024
  • Last Update Posted 4 June 2024
  • Last Verified June 2024