HDHK: Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children
Study Details
Study Description
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 among a Medicaid and Children's Health Insurance Plan sample of Hispanic families.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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, and partnership with Texas Children's Health Plan provides access to Hispanic children between the ages from 5-11 from which to recruit.
Study Design
Arms and Interventions
| 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:
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| 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.
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Outcome Measures
Primary Outcome Measures
- Father´s weight [12 months]
weight in kg
- Child´s moderate to vigorous physical activity (MVPA) [12 months]
MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Secondary Outcome Measures
- Father´s weight [4 months]
weight in kg
- Child´s MVPA [4 months]
MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
- Father´s MVPA [4 and 12 months]
MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
- Child´s and father's dietary intake [4 and 12 months]
Separate NCI´s ASA 24 hour dietary recalls for dads and kids. One recall at each time-point
- Child's BMI z-score [4 and 12 months]
Height (m) and weight (kg) measured and BMI z score calculated using CDC macro
- Child´s and father's screen media use [4 and 12 months]
Survey of screen use in past week
- Father's blood heart rate [4 and 12 months]
Automatic blood pressure machine
- Father's blood pressure [4 and 12 months]
Automatic blood pressure machine
- Fathers's non-HDL [4 and 12 months]
Cholestech LDX 13-452 Analyzer with the Cholestech LDX; TC/HDL Panel Test Cassette
- Father's HgbA1C [4 and 12 months]
DCA Vantage Analyzer using the DCA Vantage HBA1C test kit
- Child's and father's sedentary time [4 and 12 months]
Sedentary time will be measured by accelerometer with a minimum of 4 days of data 600 min/day
- Co-parenting alliance [4 and 12 months]
Validated survey questionnaire: Co-parenting Alliance Instrument
- Father-child bonding [4 and 12 months]
Validated survey questionnaire: Child-Parent Relationship Scale
- Father's food and physical activity parenting practices [4 and 12 months]
Validated survey questionnaire
Eligibility Criteria
Criteria
FATHER
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Father or significant male role model (e.g. step father, grandfather, uncle, or older brother) of a child 5-11 years old where the child is a Texas Children's Health Plan (TCHP) Member
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Age 18-65 year old
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Living in Greater Houston Area
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Self-identify as Hispanic or Latino
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Able to read and write in Spanish or English
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BMI >/=25 - 40
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Pass the 2015 American College of Sports Medicine's exercise participation health screener
CHILD
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5-11 year old child and up to three siblings, whose father/significant male role model is participating
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At least one of the participating siblings is a TCHP member
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
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Known diagnosis of diabetes without medical clearance from health care provider;
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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)
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Currently, or in the past 6 months, in a weight management program
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Currently, or in the past 6 months, taking medicine that can affect weight or might be affected by weight loss
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Any other disease or condition affecting their ability to participate in physical activities/exercise (e.g., physical disability, severe asthma)
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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)
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Plans of moving away from Harris County in the next year
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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)
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Unwilling to wear accelerometer for a 7 day study period at the three assessment points.
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BMI less than 25 or greater than 40.
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HbgA1C equal or greater than 6.5% at baseline data collection without medical clearance from health care provider.
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Has previously participated in studies on the Healthy Dads Healthy Kids' for US Hispanics
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History of myocarditis from COVID infection or vaccine
CHILD
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Not within the 5-11 year old child age range
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Known diagnosis of diabetes
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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)
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Inability to participate in regular physical education classes in school due to health or physical condition (e.g. physical disability, severe asthma)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Baylor College of Medicine
- University of Newcastle, Australia
- San Diego State University
- TEXAS CHILDREN'S HEALTH PLAN
- YMCA of Greater Houston
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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: Papás Saludables Niños 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, Colón García 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. Papás Saludables, Niños 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.
- H-50011
- R61HL155015