Feasibility of Healthy Dads Healthy Kids Latino

NCT03532048 | Completed Results DMC

• 2 other identifiers: H-38237R34HL131726
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Feasibility

Keywords

Hispanic; Fathers; Child; Obesity Prevention; Cultural adaptation; Weight Loss

Outcome Measures

Primary Outcomes (3)

• Retention of Subjects in Study Assessments

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

  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).

  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

  10 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

The Papás Saludables, Niños Saludables Program

Behavioral: The Papás Saludables, Niños Saludables Program

Wait-list Control

OTHER

The Papás Saludables, Niños Saludables Wait-list Control

Behavioral: The Papás Saludables, Niños Saludables Wait-list Control

Interventions

The Papás Saludables, Niños Saludables Program BEHAVIORAL

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

Intervention Group

The Papás Saludables, Niños Saludables Wait-list Control BEHAVIORAL

The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.

Wait-list Control

Eligibility Criteria

• Age: 5 Years - 65 Years
• Gender Eligibility Details: Latino/Hispanic fathers over the age of 18, with at least one healthy child between the ages 5-11 years old, and a target child between the ages of 5-11 years old who attends the TCHP Center for Children and Women Clinics in Houston, TX are eligible
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

TCHP The Center for Children and Women

Houston, Texas, 77025, United States

Location

Related Publications (4)

• 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.

  PMID: 20697417 BACKGROUND

• 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.

  PMID: 24380796 BACKGROUND

• 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.

  PMID: 26473759 BACKGROUND

• 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.

  PMID: 32466678 BACKGROUND

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Teresia O'Connor
• Organization: Baylor College of Medicine

teresiao@bcm.edu

7137986782

Study Officials

• Teresia O'Connor, MD, MPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this feasibility study there will be no masking.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Feasibility study with a randomized wait-list control group design

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 22, 2018
• Study Start: August 11, 2018
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: March 3, 2021
• Results First Posted: October 19, 2020

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)