An interventional study of The Papás Saludables, Niños Saludables Program and The Papás Saludables, Niños Saludables Wait-list Control in Feasibility, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 5 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Other
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.
This is a feasibility study of a culturally adapted version of Healthy Dads Healthy Kids for Hispanic families, called Papás Saludables, Niños Saludables. It is a father-targeted program for child obesity prevention and weight loss for fathers. The feasibility study will be conducted with 40 Hispanic families at a large community pediatric clinic serving children with Medicaid or CHIP. Enrollment will include fathers, their 5-11 year old child(ren) and their co-parent (e.g. mother) as a family unit (anticipate 160 individuals). Fathers and their child(ren) will be the primary target in the study, but mothers also participate, if available. Multiple children per family can enroll if they meet the inclusion/exclusion criteria, but families will be encouraged to limit the number of children who participate to no more than three. Fathers will be screened for their health to participate in the physical activity portion of the study and whether they meet inclusion/exclusion criteria. The health screening will follow the 2015 updated American College of Sport Medicine exercise pre-participation screening protocol. Fathers who otherwise qualify, but do not pass the health screener will be provided a letter to be seen by their PCP to obtain clearance for exercise participation. If they do not have a PCP they will be instructed to contact their health insurance for a list of doctors and if they do not have health insurance, a list of sliding scale clinics will be provided.
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.
Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
"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:
The Papás Saludables, Niños Saludables Program
Behavioral: The Papás Saludables, Niños Saludables Program
The Papás Saludables, Niños Saludables Wait-list Control
Behavioral: The Papás Saludables, Niños Saludables Wait-list Control
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.
Also known as: Culturally adapted Healthy Dads Healthy Kids Program
The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
Retention of Subjects in Study Assessments
Retain 80% of intervention and control participants for pre- and post-assessments
Time frame: 5 months
Recruitment of Subjects Into Study
Recruitment criteria was to recruit 40 Latino fathers and their families in ≤ 4 months. The actual recruited number of fathers with their family is reported as the outcome withe the percentage of goal achieved (actual/goal).
Time frame: 4 months
Subject Attendance to Program Sessions
Attendance of families to the 10 PSNS program sessions were recorded each week for the intervention group and later the wait-list control group. The goals was to maintain ≥70% attendance to program sessions
Time frame: 10 weeks
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"
The participating Latino fathers will be satisfied with the program as measured by 80% 'excellent'-'good' satisfaction from questionnaires and exit interviews with the Latino fathers and their co-parent (typically children's mother).
Time frame: 10 weeks
Data Collection Completeness
Ability to collect anthropometric, behavioral and parenting data on at least 75% of the Latino fathers and anthropometric, and behavioral data on their children (both groups) at baseline and follow up
Time frame: 5 months
Goal of 40 families (160 individuals) to be recruited.
| Milestone | Intervention Group | Wait-list Control |
|---|---|---|
| Started | 68 | 67 |
| Completed | 49 | 50 |
| Not completed | 19 | 17 |
| Withdrew: Lost to follow-up | 12 | 17 |
| Withdrew: Withdrawal by subject | 7 | 0 |
Retain 80% of intervention and control participants for pre- and post-assessments
| families | Intervention Group | Wait-list Control |
|---|---|---|
| Retention of Subjects in Study Assessments | 14 | 13 |
Recruitment criteria was to recruit 40 Latino fathers and their families in ≤ 4 months. The actual recruited number of fathers with their family is reported as the outcome withe the percentage of goal achieved (actual/goal).
| families | Intervention Group | Wait-list Control |
|---|---|---|
| Recruitment of Subjects Into Study | 19 | 17 |
Attendance of families to the 10 PSNS program sessions were recorded each week for the intervention group and later the wait-list control group. The goals was to maintain ≥70% attendance to program sessions
| sessions attended | Intervention Group | Wait-list Control |
|---|---|---|
| Subject Attendance to Program Sessions | 5.6 ± 4.1 | 5.6 ± 3.8 |
The participating Latino fathers will be satisfied with the program as measured by 80% 'excellent'-'good' satisfaction from questionnaires and exit interviews with the Latino fathers and their co-parent (typically children's mother).
| Participants | Intervention Group | Wait-list Control |
|---|---|---|
| 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 |
Ability to collect anthropometric, behavioral and parenting data on at least 75% of the Latino fathers and anthropometric, and behavioral data on their children (both groups) at baseline and follow up
| families | Intervention Group | Wait-list Control |
|---|---|---|
| Data Collection Completeness | 13 | 13 |
Collected over 3 months during the intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/68 (0%) | 0/68 (0%) | 0/68 (0%) |
| Wait-list Control | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| Age, Continuous(years) | Intervention Group | Wait-list Control | Total |
|---|---|---|---|
| Fathers | 36.8 ± 7.61 | 36.1 ± 5.25 | 36.5 ± 6.52 |
| Children | 8.8 ± 2.26 | 8.1 ± 1.96 | 8.5 ± 2.12 |
| Mothers | NA ± NA | NA ± NA | NA ± NA |
| Sex: Female, Male(Participants) | Intervention Group | Wait-list Control | Total |
|---|---|---|---|
| Female | 34 | 37 | 71 |
| Male | 34 | 30 | 64 |
| Race/Ethnicity, Customized(Participants) | Intervention Group | Wait-list Control | Total |
|---|---|---|---|
| Hispanic : Fathers | 19 | 17 | 36 |
| Hispanic : Children | NA | NA | NA |
| Hispanic : Mothers | NA | NA | NA |
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