- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03469752
Latino Fathers Promoting Healthy Youth Behaviors
Study Overview
Status
Intervention / Treatment
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:
- 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).
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55108
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Latino adolescent 10-14 years
Exclusion Criteria:
- Not identifying as a Latino adolescent 10-14 years
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
8 weekly education sessions 2.5 hours
|
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
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
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
Sponsor
Publications and helpful links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-68001-24921
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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