Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03469752 |
Other study ID # |
2016-68001-24921 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2016 |
Est. completion date |
February 28, 2021 |
Study information
Verified date |
August 2021 |
Source |
University of Minnesota |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.