ObesityHDHKNCT05334420
Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children
A study testing Healthy Dads Healthy Kids in people with Obesity and Obesity, Childhood, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity, Childhood, Physical Activity
- What is being tested?
- Healthy Dads Healthy Kids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 22Show fewer
- 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 spectrum disorder)
- Any Known diagnosis of an eating disorder (e.g. anorexia nervosa, bulimia nervosa, etc.) MOTHER
- No father figure to her children enrolled in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Trial of a Program for Weight Loss for Hispanic Fathers and Increased Physical Activity for Their Children: Healthy Dads, Healthy Kids
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.
Read the 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.
- Conditions
- Obesity, Obesity, Childhood, Physical Activity, Dietary Intake
- Being tested
- Healthy Dads Healthy Kids, Standard of care control
- Keywords
- Hispanic, Latino, Family based intervention, Father
- Medical subject headings
- Obesity, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Dads Healthy KidsBehavioural
Also called Papás Saludables, Niños Saludables
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.
Standard of care controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Dads Healthy Kids | Experimental | A group-based lifestyle behavioral program for Hispanic fathers and children Receives: Behavioral: Healthy Dads Healthy Kids |
| Standard of care control | Other | National guidelines and recommendations for healthy eating, physical activity and weight loss. Receives: Other: Standard of care control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Father´s weight
weight in kg
Measured: 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
Measured: 12 months
Secondary outcomes (14)
Father´s weight
weight in kg
Measured: 4 months
Child´s MVPA
MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Measured: 4 months
Father´s MVPA
MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Measured: 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
Measured: 4 and 12 months
Child's BMI z-score
Height (m) and weight (kg) measured and BMI z score calculated using CDC macro
Measured: 4 and 12 months
Child´s and father's screen media use
Survey of screen use in past week
Measured: 4 and 12 months
Father's blood heart rate
Automatic blood pressure machine
Measured: 4 and 12 months
Father's blood pressure
Automatic blood pressure machine
Measured: 4 and 12 months
Fathers's non-HDL
Cholestech LDX 13-452 Analyzer with the Cholestech LDX; TC/HDL Panel Test Cassette
Measured: 4 and 12 months
Father's HgbA1C
DCA Vantage Analyzer using the DCA Vantage HBA1C test kit
Measured: 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
Measured: 4 and 12 months
Co-parenting alliance
Validated survey questionnaire: Co-parenting Alliance Instrument
Measured: 4 and 12 months
Father-child bonding
Validated survey questionnaire: Child-Parent Relationship Scale
Measured: 4 and 12 months
Father's food and physical activity parenting practices
Validated survey questionnaire
Measured: 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start16 May 2022
- Primary completion26 Feb 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Newcastle, Australia, San Diego State University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Teresia O'Connor, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334420
- Sponsor's protocol ID
- H-50011
- Other IDs
- R61HL155015
- Acronym
- HDHK
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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: Papas Saludables Ninos Saludables. Child Obes. 2020 Sep;16(6):379-392. doi: 10.1089/chi.2020.0006. Epub 2020 May 28.
PubMed 32466678O'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.
PubMed 32316983Perez 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.
PubMed 33358181
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Trial of a Program for Weight Loss for Hispanic Fathers and Increased Physical Activity for Their Children: Healthy Dads, Healthy Kids
- ClinicalTrials.gov ID
- NCT05334420
- Acronym / sponsor ID
- HDHK / H-50011
- Conditions
- Obesity, Obesity, Childhood, Physical Activity, Dietary Intake
- Keywords
- Hispanic, Latino, Family based intervention, Father
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of Newcastle, Australia, San Diego State University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Dads Healthy Kids | Experimental | Behavioral: Healthy Dads Healthy KidsA group-based lifestyle behavioral program for Hispanic fathers and children |
| Standard of care control | Other | Other: Standard of care controlNational guidelines and recommendations for healthy eating, physical activity and weight loss. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Dads Healthy KidsAlso: Papás Saludables, Niños SaludablesGroup 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. | Behavioural | Healthy Dads Healthy Kids |
| Standard of care controlFamilies 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. | Other | Standard of care control |
Primary outcome
Father´s weight
Time frame: 12 months
weight in kg
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
14 secondary outcomes
Father´s weight
Time frame: 4 months
Child´s MVPA
Time frame: 4 months
Father´s MVPA
Time frame: 4 and 12 months
Child´s and father's dietary intake
Time frame: 4 and 12 months
Child's BMI z-score
Time frame: 4 and 12 months
Child´s and father's screen media use
Time frame: 4 and 12 months
Father's blood heart rate
Time frame: 4 and 12 months
Father's blood pressure
Time frame: 4 and 12 months
Fathers's non-HDL
Time frame: 4 and 12 months
Father's HgbA1C
Time frame: 4 and 12 months
Child's and father's sedentary time
Time frame: 4 and 12 months
Co-parenting alliance
Time frame: 4 and 12 months
Father-child bonding
Time frame: 4 and 12 months
Father's food and physical activity parenting practices
Time frame: 4 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 32466678O'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.
- Background: PubMed 32316983O'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.
- Background: PubMed 33358181Perez 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Dads Healthy Kids in people with Obesity and Obesity, Childhood, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Father´s weight (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334420, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.