- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03532048
Feasibility of Healthy Dads Healthy Kids Latino
Adapting and Assessing the Feasibility Of 'Healthy Dads Healthy Kids' For US Latinos
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77025
- TCHP The Center for Children and Women
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention Group
The Papás Saludables, Niños Saludables Program
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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.
Other Names:
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OTHER: Wait-list Control
The Papás Saludables, Niños Saludables Wait-list Control
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The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention of Subjects in Study Assessments
Time Frame: 5 months
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Retain 80% of intervention and control participants for pre- and post-assessments
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5 months
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Recruitment of Subjects Into Study
Time Frame: 4 months
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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).
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4 months
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Subject Attendance to Program Sessions
Time Frame: 10 weeks
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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
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10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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"
Time Frame: 10 weeks
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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).
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10 weeks
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Data Collection Completeness
Time Frame: 5 months
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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
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5 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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: Papas Saludables Ninos Saludables. Child Obes. 2020 Sep;16(6):379-392. doi: 10.1089/chi.2020.0006. Epub 2020 May 28.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-38237
- R34HL131726 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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