Clinical trial NCT05334420: Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children
Official title: Efficacy Trial of a Program for Weight Loss for Hispanic Fathers and Increased Physical Activity for Their Children: Healthy Dads, Healthy Kids
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Obesity, Childhood
Physical Activity
Dietary Intake
Keywords: Hispanic
Latino
Family based intervention
Father
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: University of Newcastle, Australia
name: San Diego State University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-04-19
Enrollment: 187
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Father´s weight
timeFrame: 12 months
measure: Child´s moderate to vigorous physical activity (MVPA)
timeFrame: 12 months
Secondary outcomes:
measure: Father´s weight
timeFrame: 4 months
measure: Child´s MVPA
timeFrame: 4 months
measure: Father´s MVPA
timeFrame: 4 and 12 months
measure: Child´s and father's dietary intake
timeFrame: 4 and 12 months
measure: Child's BMI z-score
timeFrame: 4 and 12 months
measure: Child´s and father's screen media use
timeFrame: 4 and 12 months
measure: Father's blood heart rate
timeFrame: 4 and 12 months
measure: Father's blood pressure
timeFrame: 4 and 12 months
measure: Fathers's non-HDL
timeFrame: 4 and 12 months
measure: Father's HgbA1C
timeFrame: 4 and 12 months
measure: Child's and father's sedentary time
timeFrame: 4 and 12 months
measure: Co-parenting alliance
timeFrame: 4 and 12 months
measure: Father-child bonding
timeFrame: 4 and 12 months
measure: Father's food and physical activity parenting practices
timeFrame: 4 and 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
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citation: 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.
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.