Feasibility of Healthy Dads Healthy Kids Latino
Condition: Feasibility
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): The Papás Saludables, Niños Saludables Program; The Papás Saludables, Niños Saludables Wait-list Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
Other intervention name(s): Culturally adapted Healthy Dads Healthy Kids Program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Feasibility study with a randomized wait-list control group design
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hispanic; Fathers; Child; Obesity Prevention; Cultural adaptation; Weight Loss