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Latino Fathers Promoting Healthy Youth Behaviors

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ClinicalTrials.gov Identifier: NCT03469752
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The purpose of this study is to evaluate the efficacy of Latino parent-focused education that combines enhancing parent engagement, building quality parent-child relationships, promoting healthy eating and physical activity, and engaging families with community resources for healthy foods on youth energy balance related behaviors and weight status.

Condition or disease Intervention/treatment Phase
Diet Modification Physical Activity Parenting Adolescent Obesity Behavioral: Parent education classes Not Applicable

Detailed Description:

The Latino Parents Promoting Healthy Youth Behavior Project aims to develop and evaluate the effectiveness of an intervention to prevent obesity among Latino youth (10-14 yrs) by engaging parents and their families in culturally and linguistically appropriate education. The goal of this project is to prevent overweight and obesity in Latino adolescents by increasing the frequency of positive paternal or maternal (or other caregiver) parenting practices related to the food and physical activity environment in the home (role modeling, availability, expectations, communication) which will improve weight status of children by improving energy balance related behaviors (EBRBs) - eating fruits and vegetables and limiting soft drink, sweets, salty snacks, and fast food consumption, limiting screen time and increasing physical activity).

Objective 1) To adapt, implement and evaluate efficacy of a curriculum specifically for Latino families, using Community-Based Participatory Research (CBPR) that incorporates parenting education to increase frequency of parenting practices (role modeling, availability, expectations, communication) to improve EBRBs and weight status of youth.

Objective 2) To evaluate the efficacy of Latino parent-focused education that combines enhancing parent engagement, building quality parent-child relationships, promoting healthy eating and physical activity, and engaging families with community resources for healthy foods on youth EBRBs and weight status.

Formative research and planning will be completed in Years 1-2 including focus group interviews and consultation with community partners and a Parent Advisory Board. An existing 8-session course curriculum will be adapted. The adapted curriculum will be pilot-tested with a small group of parents and children in a single group, pre-post design, and revised as needed.

In years 2 to 4, a randomized-controlled trial (RCT) will be conducted based on full implementation of the adapted curriculum by collaborating agencies with the support of U of MN Extension. Training will be designed and implemented among community partner and U of MN Extension staff who will be implementing the program at local sites.

The RCT will be implemented at two organizations in each of years 2, 3 and 4 in a staggered fashion. In year 5, data will be analyzed, reports developed, papers written and submitted for publication, and results will be reported back to community collaborators (organizations and individuals).

Hypothesis:

  1. Compared to a delayed-treatment control group at immediate post-course and 3 months post-course, statistically significant changes will be observed in the home food and physical activity environment and frequency of related paternal and maternal parenting practices (making fruits, vegetables, and opportunities for physical activity more available and sugar-sweetened beverages (SSBs), sweets, salty snacks, fast food and opportunities for sedentary behaviors less available; role modeling of positive EBRBs, setting expectations and rules related to improvements in EBRBs, and increased frequency of parent-youth communication regarding youth EBRBs).
  2. Compared to a delayed-treatment control group at immediate post-course and 3 months post-course, youth in the treatment group will have statistically significant improvements in EBRBs including increased fruit and vegetable intake, increased physical activity, lower intake of SSBs, sweets, salty snacks and fast food, decreased screen time/sedentary time, and stable weight status.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized-controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Latino Fathers Promoting Healthy Youth Behaviors
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : February 28, 2021

Arm Intervention/treatment
Experimental: Intervention group
8 weekly education sessions 2.5 hours
Behavioral: Parent education classes
8 weekly classes for fathers and youth (10-14 years) at community centers focused on improving parenting skills, youth energy balance related behaviors and weight status
No Intervention: Wait-list control group
No education sessions



Primary Outcome Measures :
  1. 3 24-hour diet recalls [ Time Frame: Baseline to 3 months ]
    Dietary intake (fruits, vegetables, sweetened beverages, sweets and salty snacks, family meals)

  2. Physical activity [ Time Frame: Baseline to 3 months ]
    Physical activity survey


Secondary Outcome Measures :
  1. Parenting practice survey [ Time Frame: Baseline to 3 months ]
    Frequency of role modeling, setting expectations, making opportunities for healthy choices available



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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Latino adolescent 10-14 years

Exclusion Criteria:

  • Not identifying as a Latino adolescent 10-14 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469752


Locations
United States, Minnesota
University of Minnesota Recruiting
Saint Paul, Minnesota, United States, 55108
Contact: Marla Reicks, PhD    612-624-4735    mreicks@umn.edu   
Contact: Alejandro Peralta Reyes, MPH    612-625-5781    reyes067@umn.edu   
Sub-Investigator: Ghaffar A Hurtado Choque, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03469752     History of Changes
Other Study ID Numbers: 2016-68001-24921
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Hispanic Latino families

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms