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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05334420
Other study ID # H-50011
Secondary ID R61HL155015
Status Recruiting
Phase N/A
First received
Last updated
Start date April 28, 2022
Est. completion date August 31, 2026

Study information

Verified date June 2024
Source Baylor College of Medicine
Contact Teresia O'Connor, MD, MPH
Phone 7137986782
Email teresiao@bcm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hispanic men and children experience health disparities for overweight and obesity-related medical conditions, and therefore family level obesity prevention programs for Hispanic populations are needed. 'Healthy Dads Healthy Kids' is the first program to primarily target fathers for obesity prevention for themselves and their children, with significant and clinically relevant treatment effects. This is an efficacy trial to assess a culturally adapted 'Healthy Dads Healthy Kids' for Hispanic families.


Description:

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Study Design


Intervention

Behavioral:
Healthy Dads Healthy Kids
Group based lifestyle behavioral intervention for weight loss for fathers and increased physical activity for their child. The program meets weekly 90-minute sessions over 10 weeks. Mothers/partners are invited to one session (Week 4). Each meeting consisted of a brief review session with Dads and Kids together (15 minutes), separate break-out discussion for Dads (Dad's Club) and Kids (Kid's Club) (30 minutes); and a joint physical activity component for Dads and Kids (Sports Club) (45 minutes). Each week covers different topics for fathers and a corresponding session for kids. The program encourages fathers to be healthy, positive role models for their children, and teaching fathers weight loss strategies, authoritative parenting strategies and to encourage healthy behaviors in their kids. Fathers and kids are encouraged to eat healthy, reduce their screen time and be more active. If the COVID pandemic prevents in-person meetings, the program will be delivered virtually.
Other:
Standard of care control
Families will receive handouts on healthy eating, physical activity and screen media use to promote healthy weight status. Fathers will attend one group session with a focus on dietary changes and increased physical activity to promote healthy weight loss.

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas

Sponsors (4)

Lead Sponsor Collaborator
Baylor College of Medicine National Heart, Lung, and Blood Institute (NHLBI), San Diego State University, University of Newcastle, Australia

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

O'Connor TM, Perez O, Beltran A, Colon Garcia I, Arredondo E, Parra Cardona R, Cabrera N, Thompson D, Baranowski T, Morgan PJ. Cultural adaptation of 'Healthy Dads, Healthy Kids' for Hispanic families: applying the ecological validity model. Int J Behav Nutr Phys Act. 2020 Apr 21;17(1):52. doi: 10.1186/s12966-020-00949-0. — View Citation

Perez O, Beltran A, Isbell T, Galdamez-Calderon E, Baranowski T, Morgan PJ, O'Connor TM. Papas Saludables, Ninos Saludables: Perspectives From Hispanic Parents and Children in a Culturally Adapted Father-Focused Obesity Program. J Nutr Educ Behav. 2021 Mar;53(3):246-253. doi: 10.1016/j.jneb.2020.11.006. Epub 2020 Dec 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Father´s weight weight in kg 12 months
Primary Child´s moderate to vigorous physical activity (MVPA) MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day 12 months
Secondary Father´s weight weight in kg 4 months
Secondary Child´s MVPA MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day 4 months
Secondary Father´s MVPA MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day 4 and 12 months
Secondary Child´s and father's dietary intake Separate NCI´s ASA 24 hour dietary recalls for dads and kids. One recall at each time-point 4 and 12 months
Secondary Child's BMI z-score Height (m) and weight (kg) measured and BMI z score calculated using CDC macro 4 and 12 months
Secondary Child´s and father's screen media use Survey of screen use in past week 4 and 12 months
Secondary Father's blood heart rate Automatic blood pressure machine 4 and 12 months
Secondary Father's blood pressure Automatic blood pressure machine 4 and 12 months
Secondary Fathers's non-HDL Cholestech LDX 13-452 Analyzer with the Cholestech LDX; TC/HDL Panel Test Cassette 4 and 12 months
Secondary Father's HgbA1C DCA Vantage Analyzer using the DCA Vantage HBA1C test kit 4 and 12 months
Secondary Child's and father's sedentary time Sedentary time will be measured by accelerometer with a minimum of 4 days of data 600 min/day 4 and 12 months
Secondary Co-parenting alliance Validated survey questionnaire: Co-parenting Alliance Instrument 4 and 12 months
Secondary Father-child bonding Validated survey questionnaire: Child-Parent Relationship Scale 4 and 12 months
Secondary Father's food and physical activity parenting practices Validated survey questionnaire 4 and 12 months
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