Feasibility of Healthy Dads Healthy Kids Latino

Feasibility Clinical Trial

Official title:

Adapting and Assessing the Feasibility Of 'Healthy Dads Healthy Kids' For US Latinos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532048
• Other study ID #: H-38237
• Secondary ID: R34HL131726
• Status: Completed
• Phase: N/A
• Start date: August 11, 2018
• Est. completion date: May 6, 2019

Study information

• Verified date: February 2021
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 6, 2019
• Est. primary completion date: May 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

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 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:

• Child or parent with a disease affecting their dietary intake (severe GI disease or multiple food allergies), physical activity behaviors (e.g., physical disability, severe asthma), cognitive functioning (e.g., Down's syndromes, Fragile X), or psychiatric functioning (e.g. schizophrenia in parent)

• 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.

Related Conditions & MeSH terms

• Feasibility

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	TCHP The Center for Children and Women	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View 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: Papás Saludables Niños Saludables. Child Obes. 2020 Sep;16(6):379-392. doi: 10.1089/chi.2020.0006. Epub 2020 May 28. — View Citation

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. Erratum in: Med Sci Sports Exerc. 2016 Mar;48(3):579. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of Subjects in Study Assessments	Retain 80% of intervention and control participants for pre- and post-assessments	5 months
Primary	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).	4 months
Primary	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	10 weeks
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"	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).	10 weeks
Secondary	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	5 months