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

NCT ID: NCT05334420

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2026-08-31

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.

Conditions

Obesity; Obesity, Childhood; Physical Activity; Dietary Intake

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Healthy Dads Healthy Kids

A group-based lifestyle behavioral program for Hispanic fathers and children

Group Type: EXPERIMENTAL

Healthy Dads Healthy Kids

Intervention Type: BEHAVIORAL

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.

Standard of care control

National guidelines and recommendations for healthy eating, physical activity and weight loss.

Group Type: OTHER

Standard of care control

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Papás Saludables, Niños Saludables

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Newcastle, Australia

OTHER

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Teresia O'Connor

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

De Boer RJ, Perelson AS. Towards a general function describing T cell proliferation. J Theor Biol. 1995 Aug 21;175(4):567-76. doi: 10.1006/jtbi.1995.0165.

Reference Type: BACKGROUND

PMID: 7475092 (View on PubMed)

Godel V, Regenbogen L, Feiler-Ofry V, Lazar M. Vitreoretinal degeneration in facial clefting syndrome. Birth Defects Orig Artic Ser. 1982;18(6):581-6. No abstract available.

Reference Type: BACKGROUND

PMID: 7171778 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33358181 (View on PubMed)

Other Identifiers

R61HL155015

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-50011

Identifier Type: -

Identifier Source: org_study_id