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

Primary Purpose

Obesity, Obesity, Childhood, Physical Activity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Dads Healthy Kids
Standard of care control
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Hispanic, Latino, Family based intervention, Father

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

FATHER

  • 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
  • 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

Sites / Locations

  • Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Healthy Dads Healthy Kids

Standard of care control

Arm Description

A group-based lifestyle behavioral program for Hispanic fathers and children

National guidelines and recommendations for healthy eating, physical activity and weight loss.

Outcomes

Primary Outcome Measures

Father´s weight
weight in kg
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

Secondary Outcome Measures

Father´s weight
weight in kg
Child´s MVPA
MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Father´s MVPA
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
Separate NCI´s ASA 24 hour dietary recalls for dads and kids. One recall at each time-point
Child's BMI z-score
Height (m) and weight (kg) measured and BMI z score calculated using CDC macro
Child´s and father's screen media use
Survey of screen use in past week
Father's blood heart rate
Automatic blood pressure machine
Father's blood pressure
Automatic blood pressure machine
Fathers's non-HDL
Cholestech LDX 13-452 Analyzer with the Cholestech LDX; TC/HDL Panel Test Cassette
Father's HgbA1C
DCA Vantage Analyzer using the DCA Vantage HBA1C test kit
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
Co-parenting alliance
Validated survey questionnaire: Co-parenting Alliance Instrument
Father-child bonding
Validated survey questionnaire: Child-Parent Relationship Scale
Father's food and physical activity parenting practices
Validated survey questionnaire

Full Information

First Posted
April 4, 2022
Last Updated
May 18, 2023
Sponsor
Baylor College of Medicine
Collaborators
University of Newcastle, Australia, San Diego State University, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05334420
Brief Title
Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
University of Newcastle, Australia, San Diego State University, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obesity, Childhood, Physical Activity, Dietary Intake
Keywords
Hispanic, Latino, Family based intervention, Father

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Staff involved in assessment will be masked to participant allocation.
Allocation
Randomized
Enrollment
332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Dads Healthy Kids
Arm Type
Experimental
Arm Description
A group-based lifestyle behavioral program for Hispanic fathers and children
Arm Title
Standard of care control
Arm Type
Other
Arm Description
National guidelines and recommendations for healthy eating, physical activity and weight loss.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Dads Healthy Kids
Other Intervention Name(s)
Papás Saludables, Niños Saludables
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care control
Intervention Description
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 Measure Information:
Title
Father´s weight
Description
weight in kg
Time Frame
12 months
Title
Child´s moderate to vigorous physical activity (MVPA)
Description
MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Father´s weight
Description
weight in kg
Time Frame
4 months
Title
Child´s MVPA
Description
MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Time Frame
4 months
Title
Father´s MVPA
Description
MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Time Frame
4 and 12 months
Title
Child´s and father's dietary intake
Description
Separate NCI´s ASA 24 hour dietary recalls for dads and kids. One recall at each time-point
Time Frame
4 and 12 months
Title
Child's BMI z-score
Description
Height (m) and weight (kg) measured and BMI z score calculated using CDC macro
Time Frame
4 and 12 months
Title
Child´s and father's screen media use
Description
Survey of screen use in past week
Time Frame
4 and 12 months
Title
Father's blood heart rate
Description
Automatic blood pressure machine
Time Frame
4 and 12 months
Title
Father's blood pressure
Description
Automatic blood pressure machine
Time Frame
4 and 12 months
Title
Fathers's non-HDL
Description
Cholestech LDX 13-452 Analyzer with the Cholestech LDX; TC/HDL Panel Test Cassette
Time Frame
4 and 12 months
Title
Father's HgbA1C
Description
DCA Vantage Analyzer using the DCA Vantage HBA1C test kit
Time Frame
4 and 12 months
Title
Child's and father's sedentary time
Description
Sedentary time will be measured by accelerometer with a minimum of 4 days of data 600 min/day
Time Frame
4 and 12 months
Title
Co-parenting alliance
Description
Validated survey questionnaire: Co-parenting Alliance Instrument
Time Frame
4 and 12 months
Title
Father-child bonding
Description
Validated survey questionnaire: Child-Parent Relationship Scale
Time Frame
4 and 12 months
Title
Father's food and physical activity parenting practices
Description
Validated survey questionnaire
Time Frame
4 and 12 months

10. Eligibility

Sex
All
Gender Based
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
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresia O'Connor, MD, MPH
Phone
7137986782
Email
teresiao@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Beltran, MS
Phone
713-798-0503
Email
abeltran@bcm.edu
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresia O'Connor, MD, MPH
Phone
713-798-6782
Email
teresiao@bcm.edu
First Name & Middle Initial & Last Name & Degree
Teresia M O'Connor, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
after completion of study (anticipated August 2026)
IPD Sharing Access Criteria
Valid research question posed by investigators at an academic institution. IRB approval obtained Data sharing agreement in place
Citations:
PubMed Identifier
32466678
Citation
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.
Results Reference
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PubMed Identifier
32316983
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.
Results Reference
background
PubMed Identifier
33358181
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.
Results Reference
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Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children

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