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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Obesity, Childhood, Physical Activity, Dietary Intake

Intervention / Treatment
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* Behavioral: Healthy Dads Healthy Kids
* Other: Standard of care control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Dads Healthy Kids<br>A group-based lifestyle behavioral program for Hispanic fathers and children | Behavioral: Healthy Dads Healthy Kids<br>* 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.<br>* Other names: Papás Saludables, Niños Saludables;|
| Other: Standard of care control<br>National guidelines and recommendations for healthy eating, physical activity and weight loss. | Other: Standard of care control<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hispanic, Latino, Family based intervention, Father