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

NCT05334420 | Active Not Recruiting DMC

• 2 other identifiers: H-50011R61HL155015
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Obesity, Childhood; Physical Activity; Dietary Intake

Keywords

Hispanic; Latino; Family based intervention; Father

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Father´s weight

  4 months

• Child´s MVPA

  4 months

• Father´s MVPA

  4 and 12 months

• Child´s and father's dietary intake

  4 and 12 months

• Child's BMI z-score

  4 and 12 months

Study Arms (2)

Healthy Dads Healthy Kids

EXPERIMENTAL

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

Behavioral: Healthy Dads Healthy Kids

Standard of care control

OTHER

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

Other: Standard of care control

Interventions

Healthy Dads Healthy Kids 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.

Also known as: Papás Saludables, Niños Saludables

Healthy Dads Healthy Kids

Standard of care control 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.

Standard of care control

Eligibility Criteria

• Age: 5 Years - 65 Years
• Gender Eligibility Details: In order to participate, a person identified as a child's father figure (male gender) needs to enroll as the target of the study
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 32466678 BACKGROUND

• 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.

  PMID: 32316983 BACKGROUND

• 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.

  PMID: 33358181 BACKGROUND

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff involved in assessment will be masked to participant allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Randomized controlled trial with family unit (minimum of father-child, maximum of father, 3 siblings, and mother/partner) randomized to intervention or standard of care control.

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 19, 2022
• Study Start: May 16, 2022
• Primary Completion: February 26, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after completion of study (anticipated August 2026)
• Access Criteria: Valid research question posed by investigators at an academic institution. IRB approval obtained Data sharing agreement in place

Locations

US (1)