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The Impact of a Parenting Intervention on Latino Youth Health Behaviors (FPNG+)

Primary Purpose

Diet Modification, Substance Use Disorders, Diabetes Mellitus Risk

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition/substance use prevention
Substance use prevention only
Academic success program
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diet Modification

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Youth: ages 12-14
  • Youth: Enrolled in 6th,7th, or 8th grade at the time of recruitment from the American Dream Academy (ADA) programs
  • Adults: Age 18 or older
  • Adults: Parent/caregiver/guardian of an eligible youth

Exclusion Criteria: None

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Nutrition/substance use prevention

Substance use prevention only

Academic success program

Arm Description

Parenting and nutrition curriculum targeting substance use prevention and diet improvement.

Parenting curriculum targeting substance use prevention only.

Control program focused only on academic success.

Outcomes

Primary Outcome Measures

Recent use of substances
Survey questions: Changes in amount and frequency of alcohol, cigarettes, marijuana, and inhalants in the past 30 days. Scale ranges from 1 (no use of substance) to 7 (used 40 or more times). Higher score indicates more use.
Drug resistance strategies
Survey questions: Change in youths' responses to substance use offers in the past 30 days and likely responses to hypothetical substance use offers. Scale ranges from 1 (never responded in this way) to 6 (responded this way more than 10 times).
Nutrition outcomes
NCI Dietary Screener: Change in intake of fruit, vegetables, and sugar-laden foods
Overall family functioning
Survey questions (parents) measuring: Change in family support, family conflict, parental monitoring, extent of involvement, and familism.
Parents' social support
Social Support Questionnaire score. Scale from 1 (very dissatisfied with support) to 6 (very satisfied with support). Higher scores mean more social support.
Acculturation
Acculturation Rating Scale for Mexican Americans-II (ARSMA-II) asks participants to indicate on a five point likert scale (Not at all (1) and Extremely often or almost always (5)) the extent to which they engage in 17 Mexican oriented behaviors. The Anglo Orientation Subscale (AOS) consists of 13 items, which asks participants to indicate on a five point likert scale (Not at all (1) and Extremely often or almost always (5)) the extent to which they engage in Anglo oriented behaviors. Means for each subscale are calculated, higher score means higher Mexican orientation and higher Anglo orientation.
Food Insecurity
Assesses financially-based food insecurity and hunger in households.
Self-efficacy for Parenting Index
A measure of parental beliefs that he/she is capable of performing parental roles/responsibilities
Parent self-agency
Gauges the parent's sense of parenting competence and ability to positively influence the child's development
Child Feeding Questionnaire
assesses parental attitudes, beliefs and practices about feeding
Multidimensional Acculturative Stress Inventory
Measures how often a person experienced certain acculturation situations and how stressful they were. Scale ranges from 0 (No, did not happen to me) to 5 (Extremely stressful). Mean score is created, where higher values indicate more acculturative stress.

Secondary Outcome Measures

Body weight
Measured body weight for parents and youth.
Height
Measured height for parents and youth.
Body mass index
Calculated BMI for parents and youth estimated by dividing weight by height squared
Systolic blood pressure
Measured systolic blood pressure using an automated blood pressure monitor
Diastolic blood pressure
Measured diastolic blood pressure using an automated blood pressure monitor
Total cholesterol
Total cholesterol measured via finger prick blood sample
Glycosylated hemoglobin (HbA1c)
HbA1c measured via finger prick blood sample
Diet of adolescents
2004 Block Food Frequency Questionnaire
Diet of the parents
Southwestern Food Frequency Questionnaire
Home food environment
Modified version of the validated Home Food Inventory with cultural adaptations including foods commonly consumed by Latinos.

Full Information

First Posted
March 22, 2018
Last Updated
May 17, 2022
Sponsor
Arizona State University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03517111
Brief Title
The Impact of a Parenting Intervention on Latino Youth Health Behaviors
Acronym
FPNG+
Official Title
Multi-level Effects of a Parenting Intervention for Enhancing Latino Youth Health Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test if a parenting program can be used to prevent substance use among Latino youth and at the same time promote healthy eating. Pairs of 7th grade students and one of their parents will be enrolled in the study and randomly assigned to three groups: an existing parenting intervention focusing on substance use prevention (FPNG), the enhanced parenting intervention that also has nutrition content (FPNG+), and a comparison program focused on academic success. Only parents will attend intervention sessions. Data will be collected from the parent and their 7th grade student to see how these programs impacted substance use, nutrition, and parenting. The investigators hypothesize that families receiving the FPNG+ will have improved nutrition habits than the other conditions. Students in both FPNG and FPNG+ will have lower substance use rates as compared to the academic success program. In addition, the effects of parenting strategies and sociocultural factors on the FPNG and FPNG+ results will be studied.
Detailed Description
Latino youth are a population at risk for chronic diseases because of their growing overweight and obesity rates, lack of adherence to nutrition and physical activity recommendations, and greater rates of tobacco, alcohol and other drugs use than youth of other ethnic groups. Parents are an important agent of change for youth due to their ability to create a home environment that promotes healthful behaviors (including substance use prevention and healthy nutrition), and parents' role as providers of resources to the family (including food). Parenting interventions are efficacious in preventing substance use among Latino youth, but few studies have used a family approach to promote healthy nutrition. Thus, the overall objective of the proposed project is to extend the scope of Families Preparing the New Generation (FPNG), an existing parenting program proven to help reduce substance use among Latino youth, to also promote healthy nutrition. The eco-developmental perspective will provide the theoretical foundation for the project for investigating risk and resiliency in Latino youth's drug use and nutrition behaviors. The main aims of the study are to (1) test the effects of a nutrition-enhanced parenting program (FPNG+) on substance use and nutrition among Latino youth, (2) explore how enhancing parenting skills impact the effects of the enhanced intervention, and (3) understand how social and cultural factors impact how the enhanced program works. The research team will first seek input from community members to create a nutrition-enhanced program that is acceptable to Latino parents of middle school students. The investigators will then collaborate with the American Dream Academy (ADA), an organization delivering an academic success program to families within middle schools throughout the Phoenix Area, to recruit 1,494 families who have a student in 7th grade to participate in the study. Parents from different schools will be offered one of three 10-week programs (assigned to each individual school): FPNG+ (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and the ADA comparison program (focusing on academic success). Data will be collected from the 7th grade student and his/her participating parent before the start of the program, immediately after it ends, and 16 weeks later, to compare how the programs affect nutrition, substance use, and parenting. In a subgroup of 126 families (42 from each program), investigators will explore how the FPNG+ program affects diabetes and cardiovascular risk factors and whether the program induces changes in the types of foods available at participants' homes. For this, investigators will collect capillary blood samples from participants to measure glycosylated hemoglobin (a marker of diabetes risk) and cholesterol (a marker of cardiovascular risk), and blood pressure, as well as a list of foods that participants have at home. The long-term goal is to design and disseminate programs that contribute to helping parents assist their adolescent children develop and maintain long-lasting positive lifestyle behaviors in order to prevent substance use and chronic diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Modification, Substance Use Disorders, Diabetes Mellitus Risk, Cardiovascular Risk Factor, Lifestyle Risk Reduction, Parenting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization to treatment conditions (FPNG+, FPNG, or comparison [RAD]) will occur at the school level. From the 18 participating schools, 6 each will be randomized into one of the three conditions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1005 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition/substance use prevention
Arm Type
Experimental
Arm Description
Parenting and nutrition curriculum targeting substance use prevention and diet improvement.
Arm Title
Substance use prevention only
Arm Type
Active Comparator
Arm Description
Parenting curriculum targeting substance use prevention only.
Arm Title
Academic success program
Arm Type
Sham Comparator
Arm Description
Control program focused only on academic success.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition/substance use prevention
Other Intervention Name(s)
FPNG+
Intervention Description
Parenting program focusing on diet improvement and substance use prevention
Intervention Type
Behavioral
Intervention Name(s)
Substance use prevention only
Other Intervention Name(s)
FPNG
Intervention Description
Parenting program focusing only on substance use prevention
Intervention Type
Behavioral
Intervention Name(s)
Academic success program
Other Intervention Name(s)
Realizing the American Dream (RAD)
Intervention Description
Program focusing on academic success and college acceptance
Primary Outcome Measure Information:
Title
Recent use of substances
Description
Survey questions: Changes in amount and frequency of alcohol, cigarettes, marijuana, and inhalants in the past 30 days. Scale ranges from 1 (no use of substance) to 7 (used 40 or more times). Higher score indicates more use.
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Drug resistance strategies
Description
Survey questions: Change in youths' responses to substance use offers in the past 30 days and likely responses to hypothetical substance use offers. Scale ranges from 1 (never responded in this way) to 6 (responded this way more than 10 times).
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Nutrition outcomes
Description
NCI Dietary Screener: Change in intake of fruit, vegetables, and sugar-laden foods
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Overall family functioning
Description
Survey questions (parents) measuring: Change in family support, family conflict, parental monitoring, extent of involvement, and familism.
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Parents' social support
Description
Social Support Questionnaire score. Scale from 1 (very dissatisfied with support) to 6 (very satisfied with support). Higher scores mean more social support.
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Acculturation
Description
Acculturation Rating Scale for Mexican Americans-II (ARSMA-II) asks participants to indicate on a five point likert scale (Not at all (1) and Extremely often or almost always (5)) the extent to which they engage in 17 Mexican oriented behaviors. The Anglo Orientation Subscale (AOS) consists of 13 items, which asks participants to indicate on a five point likert scale (Not at all (1) and Extremely often or almost always (5)) the extent to which they engage in Anglo oriented behaviors. Means for each subscale are calculated, higher score means higher Mexican orientation and higher Anglo orientation.
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Food Insecurity
Description
Assesses financially-based food insecurity and hunger in households.
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Self-efficacy for Parenting Index
Description
A measure of parental beliefs that he/she is capable of performing parental roles/responsibilities
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Parent self-agency
Description
Gauges the parent's sense of parenting competence and ability to positively influence the child's development
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Child Feeding Questionnaire
Description
assesses parental attitudes, beliefs and practices about feeding
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Multidimensional Acculturative Stress Inventory
Description
Measures how often a person experienced certain acculturation situations and how stressful they were. Scale ranges from 0 (No, did not happen to me) to 5 (Extremely stressful). Mean score is created, where higher values indicate more acculturative stress.
Time Frame
Week 0, Week 10-12, Week 24-26
Secondary Outcome Measure Information:
Title
Body weight
Description
Measured body weight for parents and youth.
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Height
Description
Measured height for parents and youth.
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Body mass index
Description
Calculated BMI for parents and youth estimated by dividing weight by height squared
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Systolic blood pressure
Description
Measured systolic blood pressure using an automated blood pressure monitor
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Diastolic blood pressure
Description
Measured diastolic blood pressure using an automated blood pressure monitor
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Total cholesterol
Description
Total cholesterol measured via finger prick blood sample
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Glycosylated hemoglobin (HbA1c)
Description
HbA1c measured via finger prick blood sample
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Diet of adolescents
Description
2004 Block Food Frequency Questionnaire
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Diet of the parents
Description
Southwestern Food Frequency Questionnaire
Time Frame
Week 0, Week 10-12, Week 24-26
Title
Home food environment
Description
Modified version of the validated Home Food Inventory with cultural adaptations including foods commonly consumed by Latinos.
Time Frame
Week 0, Week 10-12, Week 24-26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Youth: ages 12-14 Youth: Enrolled in 6th,7th, or 8th grade at the time of recruitment from the American Dream Academy (ADA) programs Adults: Age 18 or older Adults: Parent/caregiver/guardian of an eligible youth Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavio F Marsiglia, PhD
Organizational Affiliation
Southwest Interdisciplinary Research Center, Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31843638
Citation
Vega-Lopez S, Marsiglia FF, Ayers S, Williams LR, Bruening M, Gonzalvez A, Vega-Luna B, Perilla A, Harthun M, Shaibi GQ, Delgado F, Rosario C, Hartmann L. Methods and rationale to assess the efficacy of a parenting intervention targeting diet improvement and substance use prevention among Latinx adolescents. Contemp Clin Trials. 2020 Feb;89:105914. doi: 10.1016/j.cct.2019.105914. Epub 2019 Dec 13.
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The Impact of a Parenting Intervention on Latino Youth Health Behaviors

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