Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
160 participants
INTERVENTIONAL
2018-08-11
2019-05-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children
NCT05334420
A Nutrition and Parenting Program for Fathers and Their Pre-school Age Children
NCT03071419
Childhood Obesity Prevention Program for Hispanics
NCT01156402
Latino Fathers Promoting Healthy Youth Behaviors
NCT03469752
Latinx Family Wellness
NCT05735600
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Once screened, consented and enrolled, baseline data will be collected on the fathers, children and mothers. Data assessments include demographics, height, weight, and waist circumference on fathers and children, blood pressure and heart rate on fathers, physical activity and sleep on fathers and children (as measured by wearing accelerometers for 5-7 days), screen media use by survey questions of fathers and children, dietary intake on fathers and children (by food frequency questionnaires), food and physical activity parenting practices, co-parenting alliance scale, acculturation (Bi-Acculturation Scale), respeto (Respect sub-scale from the Mexican-American Cultural Values scale) and Pan-American familism scale on fathers and mothers. Mothers, if available, will be asked to assist the child in completing their questionnaires. If the family consists of a single father, he will assist the child in completing their questionnaires. Fathers and children will be instructed in wearing their accelerometer and told to wear it 24 hours/day for the next 7 days, only taking it off when there is potential for getting it wet (e.g. bathing, showering, swimming). Study staff will remind the father and child to wear their monitor by text, email or phone call (depending on family preference) several times during week. Accelerometers and wear logs can be returned at the clinic or by prepaid envelope provided by the study. Once received back, accelerometer data will be reviewed for completeness (minimum of 8 hours/day for 5 days including 2 weekend days). If accelerometer data is not complete, the father and/or child will be given the option to wear the monitor for additional days to complete the data.
After baseline data are collected, families will be stratified into preferred language of program (English or Spanish) and randomly assigned to receive the program immediately (Intervention Group, N=20) or after a 5-7 month wait list period (Wait-list Control group, N=20).
After the 10 session program is completed, post-assessment data will be collected on all 40 families in the same way as described for the baseline data collection. In addition, fathers, mothers and children who took part in the Papás Saludables, Niños Saludables program will be asked to complete a satisfaction survey. Families who were assigned to the control group will start the program after the second data collection. Data collection on the wait-list control group will only consist of weight, height, and satisfaction survey.
Exit interviews of a sub-sample of fathers, mothers and children each who took part in the Papás Saludables, Niños Saludables program will be conducted. The interviews will be audio-recorded and coded for themes.
Process Evaluation: Recruitment, screening and enrollment will be tracked by study staff. Attendance to the data collection sessions and HDHK program sessions will be tracked by the program facilitators and research staff. Fidelity of program delivery by the facilitator will be assessed via research staff observation and use of a delivery checklist for each session.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group
The Papás Saludables, Niños Saludables Program
The Papás Saludables, Niños Saludables Program
Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control
The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The Papás Saludables, Niños Saludables Program
Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
The Papás Saludables, Niños Saludables Wait-list Control
The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Child is a patient at one of the TCHP Center for Children and Women Clinics
* Parents able to read and write in either Spanish or English
* Latino/Hispanic families who live in the Greater Houston area
* Fathers and children willing to wear an accelerometer for a 7 day study period at baseline and 4 months later
* Fathers with a BMI \> 25 and \<40
* Fathers pass the American College of Sports Medicine (ACSM) health screener to participate or get medical clearance to participate from a medical doctor.
"Father" will be defined as an adult "father figure" in the child's life. This can include a biological father, step father, adapted father, grandfather, older adult brother, uncle or other male figure who is a father figure for the child and helps with caring/raising the child.
Exclusion Criteria
* Plans of moving away from Harris County in the next year
* Fathers BMI\>40
* Fathers who have lost more than 10 pounds recently, are in a current weight loss program or taking medications to lose weight
* Fathers who fail ACSM health screening and do not provide a MD letter approving participation in the program.
5 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Baylor College of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Teresia O'Connor
Associate Professor of Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Teresia O'Connor, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
TCHP The Center for Children and Women
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Morgan PJ, Lubans DR, Callister R, Okely AD, Burrows TL, Fletcher R, Collins CE. The 'Healthy Dads, Healthy Kids' randomized controlled trial: efficacy of a healthy lifestyle program for overweight fathers and their children. Int J Obes (Lond). 2011 Mar;35(3):436-47. doi: 10.1038/ijo.2010.151. Epub 2010 Aug 10.
Morgan PJ, Collins CE, Plotnikoff RC, Callister R, Burrows T, Fletcher R, Okely AD, Young MD, Miller A, Lloyd AB, Cook AT, Cruickshank J, Saunders KL, Lubans DR. The 'Healthy Dads, Healthy Kids' community randomized controlled trial: a community-based healthy lifestyle program for fathers and their children. Prev Med. 2014 Apr;61:90-9. doi: 10.1016/j.ypmed.2013.12.019. Epub 2013 Dec 29.
Riebe D, Franklin BA, Thompson PD, Garber CE, Whitfield GP, Magal M, Pescatello LS. Updating ACSM's Recommendations for Exercise Preparticipation Health Screening. Med Sci Sports Exerc. 2015 Nov;47(11):2473-9. doi: 10.1249/MSS.0000000000000664.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-38237
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.