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

Obesity Clinical Trial

— HDHK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05334420
• Other study ID #: H-50011
• Secondary ID: R61HL155015
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: June 2024
• Source: Baylor College of Medicine
• Contact: Teresia O'Connor, MD, MPH
• Phone: 7137986782
• Email: teresiao[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: August 31, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Intake
• Obesity
• Obesity, Childhood
• Pediatric Obesity
• Physical Activity

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Heart, Lung, and Blood Institute (NHLBI), San Diego State University, University of Newcastle, Australia

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Father´s weight	weight in kg	12 months
Primary	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	Father´s weight	weight in kg	4 months
Secondary	Child´s MVPA	MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day	4 months
Secondary	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
Secondary	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
Secondary	Child's BMI z-score	Height (m) and weight (kg) measured and BMI z score calculated using CDC macro	4 and 12 months
Secondary	Child´s and father's screen media use	Survey of screen use in past week	4 and 12 months
Secondary	Father's blood heart rate	Automatic blood pressure machine	4 and 12 months
Secondary	Father's blood pressure	Automatic blood pressure machine	4 and 12 months
Secondary	Fathers's non-HDL	Cholestech LDX 13-452 Analyzer with the Cholestech LDX; TC/HDL Panel Test Cassette	4 and 12 months
Secondary	Father's HgbA1C	DCA Vantage Analyzer using the DCA Vantage HBA1C test kit	4 and 12 months
Secondary	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
Secondary	Co-parenting alliance	Validated survey questionnaire: Co-parenting Alliance Instrument	4 and 12 months
Secondary	Father-child bonding	Validated survey questionnaire: Child-Parent Relationship Scale	4 and 12 months
Secondary	Father's food and physical activity parenting practices	Validated survey questionnaire	4 and 12 months