Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children

Not Applicable

Active, not recruiting

• Conditions: Obesity, Childhood; Physical Activity; Dietary Intake; Obesity
• Interventions: Other: Standard of care control; Behavioral: Healthy Dads Healthy Kids

• Registration Number: NCT05334420
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

Detailed Description

Hispanics in the United States face health disparities for obesity and related medical conditions, such as cardiovascular disease and diabetes. Targeting families to promote healthy lifestyle behaviors has been identified as an effective strategy to prevent obesity. With the importance of familism (family cohesion) among the Hispanic population, a family based intervention is especially desirable as an engaging strategy to promote behaviors that support a healthy weight status and decrease obesity related health disparities for Hispanics. Emerging evidence supports the need to include and target fathers in family based lifestyle behavior interventions. Healthy Dads Healthy Kids (HDHK) is an evidence based program developed in Australia, shown to have significant weight and behavior treatment effects for fathers and their children, compared to controls. The HDHK program is based on Social Cognitive Theory and Family Systems Theory and aims to promote increased physical activity and improved dietary intake for fathers and their children. An important innovation in the program is that fathers and children attend together and are both targeted as agents of behavior change for each other (reciprocal reinforcement) and to participate in fun, family activities together. HDHK was culturally adapted for Hispanic families following the Ecological Validity Model by this research team, with input from a community Hispanic family panel, expert committee and the developer of the HDHK program. The resulting Papás Saludables, Niños Saludables (PSNS) program is a 10-week group-based intervention that meets weekly.

This randomized controlled trial of PSNS is powered to detect a clinically meaningful change in father's weight and children's moderate to vigorous physical activity. The study will also assess other behavioral (dietary intake, sedentary time, screen media use, and parenting practices), psychosocial (familism, acculturation, and co-parenting alliance) and biological (child BMI z-score, father's non-HDL, HgbA1C, and BP) outcomes. Hispanic men with overweight or obesity who are a father figure (biological father, step father, grandfather, adult older brother, etc) to a 5-11 child will be enrolled in the study in waves. Participants are enrolled as a family unit and includes the father, child(ren) (up to 3 siblings) and mother/partner (if available). After screening and baseline data is complete for a wave, the family is randomized to receive a standard of care control or the group-based culturally adapted PSNS. Follow-up assessments will be done at 4 months and 12 months.

The study includes a partnership with the YMCA of Greater Houston to provide a venue for where to deliver the program.

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-19
• Study Start: 2022-04-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-03-01
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care control	Standard of care control	National guidelines and recommendations for healthy eating, physical activity and weight loss.
Healthy Dads Healthy Kids	Healthy Dads Healthy Kids	A group-based lifestyle behavioral program for Hispanic fathers and children

Primary Outcome Measures

Name	Time	Method
Child´s moderate to vigorous physical activity (MVPA)	12 months	MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Father´s weight	12 months	weight in kg

Secondary Outcome Measures

Name	Time	Method
Father´s weight	4 months	weight in kg
Child´s MVPA	4 months	MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Co-parenting alliance	4 and 12 months	Validated survey questionnaire: Co-parenting Alliance Instrument
Father's HgbA1C	4 and 12 months	DCA Vantage Analyzer using the DCA Vantage HBA1C test kit
Child's and father's sedentary time	4 and 12 months	Sedentary time will be measured by accelerometer with a minimum of 4 days of data 600 min/day
Father´s MVPA	4 and 12 months	MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Father's blood heart rate	4 and 12 months	Automatic blood pressure machine
Father's blood pressure	4 and 12 months	Automatic blood pressure machine
Fathers's non-HDL	4 and 12 months	Cholestech LDX 13-452 Analyzer with the Cholestech LDX; TC/HDL Panel Test Cassette
Child´s and father's dietary intake	4 and 12 months	Separate NCI´s ASA 24 hour dietary recalls for dads and kids. One recall at each time-point
Father-child bonding	4 and 12 months	Validated survey questionnaire: Child-Parent Relationship Scale
Father's food and physical activity parenting practices	4 and 12 months	Validated survey questionnaire
Child's BMI z-score	4 and 12 months	Height (m) and weight (kg) measured and BMI z score calculated using CDC macro
Child´s and father's screen media use	4 and 12 months	Survey of screen use in past week

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States