N/A
N=135
Feasibility of Healthy Dads Healthy Kids Latino
Feasibility
Bottom Line
View on ClinicalTrials.gov: NCT03532048 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Retention of Subjects in Study Assessments — 14; 13 families
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Papás Saludables, Niños Saludables Program (Behavioral); The Papás Saludables, Niños Saludables Wait-list Control (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention of Subjects in Study Assessments |
14; 13 | — |
| PRIMARY Recruitment of Subjects Into Study |
19; 17 | — |
| PRIMARY Subject Attendance to Program Sessions |
5.6; 5.6 | — |
| SECONDARY Percentage of Fathers and Mothers Who Reported Their Satisfaction With the PSNS Program as Excellent to Good on the "Healthy Dads Healthy Kids Satisfaction Survey" |
24; 23 | — |
| SECONDARY Data Collection Completeness |
13; 13 | — |
Summary
This is a feasibility study of a culturally adapted version of Healthy Dads Healthy Kids for Hispanic families. The adapted version called Papás Saludables, Niños Saludables is a father-targeted program for child obesity prevention and weight loss for fathers. The feasibility study will be conducted with 40 Hispanic families. Baseline assessments (T0) will be completed on all participating family members, followed by randomization to start the program immediately (intervention group), or 6-7 months later (wait-list control). Post assessments (T1) will be completed on the full sample once the intervention group has participated in the 10 week Papás Saludables, Niños Saludables program. A process evaluation will be conducted to assess the feasibility outcomes of the study.
Eligibility Criteria
Inclusion Criteria
- Latino/Hispanic fathers, mothers (if available) over the age of 18, with at least one healthy child between the ages 5-11 years old, and target child between the ages of 5-11 years old
- 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 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.
Data sourced from ClinicalTrials.gov (NCT03532048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.