Clinical trial NCT03517111: The Impact of a Parenting Intervention on Latino Youth Health Behaviors
Official title: Multi-level Effects of a Parenting Intervention for Enhancing Latino Youth Health Behaviors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diet Modification
Substance Use Disorders
Diabetes Mellitus Risk
Cardiovascular Risk Factor
Lifestyle Risk Reduction
Parenting
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-05-07
Enrollment: 844
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Adolescent Recent Alcohol Intake Frequency
timeFrame: (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26
measure: Adolescent Recent Alcohol Intake Amount
timeFrame: (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26
measure: Drug Resistance Strategies
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Self-efficacy for Parenting Index
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parents' Social Support
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent Self-agency
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Overall Family Functioning- Parental Monitoring Subscale
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Overall Family Functioning- Parental Involvement
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Overall Family Functioning- Family Support
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Overall Family Functioning: Family Conflict
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Overall Family Functioning- Familism
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Acculturation- Mexican Orientation Scale
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Acculturation- Anglo Orientation Subscale
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Multidimensional Acculturative Stress Inventory
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Nutrition Outcomes- Fruit Intake
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Nutrition Outcomes-vegetables
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Nutrition Outcomes-sugar-laden Foods
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Child Feeding Questionnaire- Weight-related Outcomes
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Child Feeding Questionnaire- Health-related Outcomes
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Food Insecurity
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary outcomes:
measure: Body Weight (kg)
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Height
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Body Mass Index for Parents
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Systolic Blood Pressure
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Diastolic Blood Pressure
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Total Cholesterol
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet- Total Energy (kcal)
timeFrame: Week 0 (t1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet- Total Dietary Fiber (g)
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Home Food Environment - Vegetable Availability
timeFrame: Week 0 (Time 1), Week 10-12 (T2), Week 24-26 (T3)
measure: BMI % for Youth
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet - % Calories From Fat
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet - % Calories From Carbs
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet - % Calories From Protein
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet - % Calories From Saturated Fats
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet - % Calories From Monounsaturated Fats
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet - % Calories From Polyunsaturated Fats
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet - Total Sugars (g)
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet - Added Sugars (g)
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet - Whole Grains (oz)
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
measure: Parent and Adolescent Diet - Refined Grains (oz)
timeFrame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Southwest Interdisciplinary Research Center, Arizona State University
name: Flavio F Marsiglia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Mercado M, Vega-Lopez S, Gonzalvez A, Vega-Luna B, Hoyt S, Martinez G, Ayers S, Marsiglia FF. Adaptation process of a culturally congruent parenting intervention for parents of Hispanic adolescents to an online synchronous format. Transl Behav Med. 2023 Apr 3;13(3):160-167. doi: 10.1093/tbm/ibac097.
citation: Masek E, Gonzalvez A, Rankin L, Vega de Luna B, Valdez HJ, Hartmann L, Lorenzo E, Bruening M, Marsiglia FF, Harthun M, Vega-Lopez S. Qualitative Research on the Perceptions of Factors Influencing Diet and Eating Behaviors Among Primarily Latinx Seventh-Grade Students. J Acad Nutr Diet. 2023 Jul;123(7):1011-1021. doi: 10.1016/j.jand.2023.02.009. Epub 2023 Feb 14.