Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children (HDHK)

Efficacy Trial of a Program for Weight Loss for Hispanic Fathers and Increased Physical Activity for Their Children: Healthy Dads, Healthy Kids

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Physical Activity; Obesity, Childhood; Dietary Intake
• Intervention / Treatment: Behavioral: Healthy Dads Healthy Kids; Other: Standard of care control

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 Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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 spectrum disorder)
• Any Known diagnosis of an eating disorder (e.g. anorexia nervosa, bulimia nervosa, etc.) MOTHER
• No father figure to her children enrolled in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Dads Healthy Kids; A group-based lifestyle behavioral program for Hispanic fathers and children	Behavioral: Healthy Dads Healthy Kids; Group based lifestyle behavioral intervention for weight loss for fathers and increased physical activity for their child. The program meets weekly 90-minute sessions over 10 weeks. Mothers/partners are invited to one session (Week 4). Each meeting consisted of a brief review session with Dads and Kids together (15 minutes), separate break-out discussion for Dads (Dad's Club) and Kids (Kid's Club) (30 minutes); and a joint physical activity component for Dads and Kids (Sports Club) (45 minutes). Each week covers different topics for fathers and a corresponding session for kids. The program encourages fathers to be healthy, positive role models for their children, and teaching fathers weight loss strategies, authoritative parenting strategies and to encourage healthy behaviors in their kids. Fathers and kids are encouraged to eat healthy, reduce their screen time and be more active. If the COVID pandemic prevents in-person meetings, the program will be delivered virtually.; Other Names: Papás Saludables, Niños Saludables
Other: Standard of care control; National guidelines and recommendations for healthy eating, physical activity and weight loss.	Other: Standard of care control; Families will receive handouts on healthy eating, physical activity and screen media use to promote healthy weight status. Fathers will attend one group session with a focus on dietary changes and increased physical activity to promote healthy weight loss.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: San Diego State University; National Heart, Lung, and Blood Institute (NHLBI); University of Newcastle, Australia

Publications and helpful links

General Publications

• O'Connor TM, Beltran A, Musaad S, Perez O, Flores A, Galdamez-Calderon E, Isbell T, Arredondo EM, Parra Cardona R, Cabrera N, Marton SA, Baranowski T, Morgan PJ. Feasibility of Targeting Hispanic Fathers and Children in an Obesity Intervention: Papas Saludables Ninos Saludables. Child Obes. 2020 Sep;16(6):379-392. doi: 10.1089/chi.2020.0006. Epub 2020 May 28.
• O'Connor TM, Perez O, Beltran A, Colon Garcia I, Arredondo E, Parra Cardona R, Cabrera N, Thompson D, Baranowski T, Morgan PJ. Cultural adaptation of 'Healthy Dads, Healthy Kids' for Hispanic families: applying the ecological validity model. Int J Behav Nutr Phys Act. 2020 Apr 21;17(1):52. doi: 10.1186/s12966-020-00949-0.
• Perez O, Beltran A, Isbell T, Galdamez-Calderon E, Baranowski T, Morgan PJ, O'Connor TM. Papas Saludables, Ninos Saludables: Perspectives From Hispanic Parents and Children in a Culturally Adapted Father-Focused Obesity Program. J Nutr Educ Behav. 2021 Mar;53(3):246-253. doi: 10.1016/j.jneb.2020.11.006. Epub 2020 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): February 26, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hispanic; Latino; Father; Family based intervention
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Pediatric Obesity; Motor Activity
• Other Study ID Numbers: H-50011; R61HL155015 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The principal investigator and co-investigators acknowledge their willingness to share data with other eligible investigators through academically established means. Summarized data will be shared with collaborators as soon as available, with local colleagues at seminars and talks, and with the scientific community at large by posters and presentations at local, regional, national and international scientific meetings.

Individual participant data may be shared with reasonable requests and data sharing agreements put in place between institutions.

• IPD Sharing Time Frame: after completion of study (anticipated August 2026)
• IPD Sharing Access Criteria: Valid research question posed by investigators at an academic institution. IRB approval obtained Data sharing agreement in place
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No