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临床试验/NCT03532048
NCT03532048已完成不适用

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

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年8月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Retention of Subjects in Study Assessments

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

In this feasibility study there will be no masking.

入排标准

年龄范围
5 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Retention of Subjects in Study Assessments

时间窗: 5 months

Retain 80% of intervention and control participants for pre- and post-assessments

Recruitment of Subjects Into Study

时间窗: 4 months

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).

Subject Attendance to Program Sessions

时间窗: 10 weeks

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

次要结局

  • 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"(10 weeks)
  • Data Collection Completeness(5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Teresia O'Connor

Associate Professor of Pediatrics

Baylor College of Medicine

研究点 (2)

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