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Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children (HDHK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05334420
Recruitment Status : Recruiting
First Posted : April 19, 2022
Last Update Posted : May 19, 2023
Sponsor:
Collaborators:
University of Newcastle, Australia
San Diego State University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Teresia O'Connor, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Obesity Obesity, Childhood Physical Activity Dietary Intake Behavioral: Healthy Dads Healthy Kids Other: Standard of care control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: Staff involved in assessment will be masked to participant allocation.
Primary Purpose: Treatment
Official Title: Efficacy Trial of a Program for Weight Loss for Hispanic Fathers and Increased Physical Activity for Their Children: Healthy Dads, Healthy Kids
Actual Study Start Date : April 28, 2022
Estimated Primary Completion Date : March 1, 2026
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine


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 Name: Papás Saludables, Niños Saludables

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.




Primary Outcome Measures :
  1. Father´s weight [ Time Frame: 12 months ]
    weight in kg

  2. Child´s moderate to vigorous physical activity (MVPA) [ Time Frame: 12 months ]
    MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day


Secondary Outcome Measures :
  1. Father´s weight [ Time Frame: 4 months ]
    weight in kg

  2. Child´s MVPA [ Time Frame: 4 months ]
    MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day

  3. Father´s MVPA [ Time Frame: 4 and 12 months ]
    MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day

  4. Child´s and father's dietary intake [ Time Frame: 4 and 12 months ]
    Separate NCI´s ASA 24 hour dietary recalls for dads and kids. One recall at each time-point

  5. Child's BMI z-score [ Time Frame: 4 and 12 months ]
    Height (m) and weight (kg) measured and BMI z score calculated using CDC macro

  6. Child´s and father's screen media use [ Time Frame: 4 and 12 months ]
    Survey of screen use in past week

  7. Father's blood heart rate [ Time Frame: 4 and 12 months ]
    Automatic blood pressure machine

  8. Father's blood pressure [ Time Frame: 4 and 12 months ]
    Automatic blood pressure machine

  9. Fathers's non-HDL [ Time Frame: 4 and 12 months ]
    Cholestech LDX 13-452 Analyzer with the Cholestech LDX; TC/HDL Panel Test Cassette

  10. Father's HgbA1C [ Time Frame: 4 and 12 months ]
    DCA Vantage Analyzer using the DCA Vantage HBA1C test kit

  11. Child's and father's sedentary time [ Time Frame: 4 and 12 months ]
    Sedentary time will be measured by accelerometer with a minimum of 4 days of data 600 min/day

  12. Co-parenting alliance [ Time Frame: 4 and 12 months ]
    Validated survey questionnaire: Co-parenting Alliance Instrument

  13. Father-child bonding [ Time Frame: 4 and 12 months ]
    Validated survey questionnaire: Child-Parent Relationship Scale

  14. Father's food and physical activity parenting practices [ Time Frame: 4 and 12 months ]
    Validated survey questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   In order to participate, a person identified as a child's father figure (male gender) needs to enroll as the target of the study
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05334420


Contacts
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Contact: Teresia O'Connor, MD, MPH 7137986782 teresiao@bcm.edu
Contact: Alicia Beltran, MS 713-798-0503 abeltran@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Teresia O'Connor, MD, MPH    713-798-6782    teresiao@bcm.edu   
Principal Investigator: Teresia M O'Connor, MD, MPH         
Sponsors and Collaborators
Baylor College of Medicine
University of Newcastle, Australia
San Diego State University
National Heart, Lung, and Blood Institute (NHLBI)
Publications:
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Responsible Party: Teresia O'Connor, Associate Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05334420    
Other Study ID Numbers: H-50011
R61HL155015 ( U.S. NIH Grant/Contract )
First Posted: April 19, 2022    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The principal investigator and co-investigators acknowledge their willingness to share data with other eligible investigators through academically established means. Summarized data will be shared with collaborators as soon as available, with local colleagues at seminars and talks, and with the scientific community at large by posters and presentations at local, regional, national and international scientific meetings.

Individual participant data may be shared with reasonable requests and data sharing agreements put in place between institutions.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teresia O'Connor, Baylor College of Medicine:
Hispanic
Latino
Family based intervention
Father
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight