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Clinical Trials/NCT03517111
NCT03517111
Terminated
Not Applicable

Multi-level Effects of a Parenting Intervention for Enhancing Latino Youth Health Behaviors

Arizona State University1 site in 1 country844 target enrollmentSeptember 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diet Modification
Sponsor
Arizona State University
Enrollment
844
Locations
1
Primary Endpoint
Adolescent Recent Alcohol Intake Amount
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 26, 2018
End Date
March 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sonia Vega-Lopez

Associate Professor, School of Nutrition and Health Promotion

Arizona State University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Adolescent Recent Alcohol Intake Amount

Time Frame: (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26

Question: How many drinks of alcohol (more than a sip of beer, wine, or liquor) have you had in the past 30 days? Scale: 0 = None; 1 = One drink; 2 = 2-3 drinks; 3 = 4-7 drinks; 4=8-15 drinks; 5=16-30 drinks; 6= More than 30 drinks

Overall Family Functioning- Parental Monitoring Subscale

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Survey questions (parents) measuring: Change in parental monitoring. Average of a 9-item scale, where each question is measured on a 5-point scale (1=Never, 5=Always).

Overall Family Functioning- Parental Involvement

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

From Gorman-Smith, Tolan, Zelli \& Huesmann (1996) - These items measure the extent to which the parent is involved in the child's life. Respondents are asked to indicate how often they engage in certain interactions with their children (Q1-2) and how often the child is involved in family activities (Q3-10). For the first two questions, (when was the most recent time parent and youth talked about certain things), the scale goes from 1 (I don't know) to 5 (yesterday or today). For questions 3-10, activities include: how often the youth helps with family fun activities, how often parent and youth have a friendly talk, whether the youth helps with chores, or errands, etc. The scale goes from 1 (hardly ever) to 5 (often). Point values are summed (MIN=10, MAX=50), and then divided by the total number of items. Higher scores indicate greater levels of parental monitoring and involvement.

Acculturation- Mexican Orientation Scale

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

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 certain cultural behaviors. The Mexican Orientation Subscale (MOS) consists of 17 Mexican oriented behaviors, which asks participants to indicate on the five point likert scale (Not at all (1) and Extremely often or almost always (5)) the extent to which they engage in Mexican-oriented behaviors. Means for each subscale are calculated, higher score indicates higher Mexican orientation.

Acculturation- Anglo Orientation Subscale

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

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 certain cultural behaviors. The Anglo Orientation Subscale (AOS) consists of 13 items, which asks participants to indicate on the 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 indicates higher Anglo orientation.

Nutrition Outcomes- Fruit Intake

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

NCI Dietary Screener: Change in intake of fruit- estimated cups per day

Nutrition Outcomes-vegetables

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

NCI Dietary Screener: Change in intake of vegetables- estimated cups per day

Child Feeding Questionnaire- Weight-related Outcomes

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

3 item subscale measuring how often parents discussed certain weight-related topics with their adolescent (1=Never or rarely; 5=Almost every day).

Parent Self-agency

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Gauges the parent's sense of parenting competence and ability to positively influence the child's development. Scale from 1-5, with higher score=more agency.

Overall Family Functioning- Familism

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Survey questions (parents) measuring familism subscale.

Child Feeding Questionnaire- Health-related Outcomes

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

3 item subscale measuring how often parents discussed certain health-related topics with their adolescent (1=Never or rarely; 5=Almost every day).

Food Insecurity

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

This five-item scale is based on an 18-item validated food insecurity scale (Blumberg et al., 1999), for use when resources do not allow the use of the full scale. It assesses financially-based food insecurity and hunger in households with and without children. Questions 1 and 2 assess if food bought didn't last, and if they couldn't afford balanced meals; scale from 1=often true to 3=never true. The rest of the questions ask about actions the parent had to take due to lack of food; it's measured on a three-point scale where 1=No, 2=Yes, and 3=I don't know. The total number of affirmative responses is tallied: Questions 1 \& 2, "Often" and "Sometimes" are considered affirmative responses; Question 3, "Yes, some months but not every month" and "Yes, almost every month" are considered affirmative responses; Questions 4 and 5, "Yes" is considered affirmative response. Minimum value is 0, maximum value is five. A greater score indicates higher level of food insecurity.

Adolescent Recent Alcohol Intake Frequency

Time Frame: (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26

Question: In the past 30 days, how many times have you...drunk more than a sip of beer, wine or liquor? Scale: 0 = 0; 1 = 1-2 times; 2 = 3-5 times; 3 = 6-9 times; 4 = 10-19 times; 5 = 20-39 times; 6 = 40 or more times

Self-efficacy for Parenting Index

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

A measure of parental beliefs that he/she is capable of performing parental roles/responsibilities

Parents' Social Support

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Social Support Questionnaire score, scale from 1 to 7. Higher scores mean more social support.

Nutrition Outcomes-sugar-laden Foods

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

NCI Dietary Screener: Change in intake of added sugars- estimated teaspoons per day

Drug Resistance Strategies

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Survey questions: Change in youths' responses to substance use offers in the past 30 days. Scale ranges from 0 (never responded in this way) to 5 (responded this way more than 10 times). Change in youths' intention to use substances measured as likely responses to hypothetical substance use offers. Scale ranges from 1 (Definitely no) to 4 (Definitely yes).

Overall Family Functioning- Family Support

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Survey questions (parents) measuring: Change in family support,

Overall Family Functioning: Family Conflict

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Sub-scale measuring family conflict.

Multidimensional Acculturative Stress Inventory

Time Frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

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 Outcomes

  • Body Weight (kg)(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Body Mass Index for Parents(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet - % Calories From Protein(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet - Added Sugars (g)(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Glycosylated Hemoglobin (HbA1c)(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Diastolic Blood Pressure(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet - % Calories From Monounsaturated Fats(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet - Refined Grains (oz)(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Height(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Systolic Blood Pressure(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Total Cholesterol(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet- Total Energy (kcal)(Week 0 (t1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet- Total Dietary Fiber (g)(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Home Food Environment - Vegetable Availability(Week 0 (Time 1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet - % Calories From Carbs(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet - Total Sugars (g)(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • BMI % for Youth(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet - % Calories From Fat(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet - % Calories From Saturated Fats(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet - % Calories From Polyunsaturated Fats(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))
  • Parent and Adolescent Diet - Whole Grains (oz)(Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3))

Study Sites (1)

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