Latino Fathers Promoting Healthy Youth Behaviors

August 19, 2021 updated by: University of Minnesota
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55108
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Latino adolescent 10-14 years

Exclusion Criteria:

  • Not identifying as a Latino adolescent 10-14 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3 24-hour diet recalls
Time Frame: Baseline to 3 months
Dietary intake (fruits, vegetables, sweetened beverages, sweets and salty snacks, family meals)
Baseline to 3 months
Physical activity
Time Frame: Baseline to 3 months
Physical activity survey
Baseline to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parenting practice survey
Time Frame: Baseline to 3 months
Frequency of role modeling, setting expectations, making opportunities for healthy choices available
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-68001-24921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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