Diet ModificationFPNG+NCT03517111

The Impact of a Parenting Intervention on Latino Youth Health Behaviors

A study testing Nutrition/substance use prevention, Substance use prevention only and Academic success program in people with Diet Modification and Substance Use Disorders, run by Arizona State University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: Diet Modification, Substance Use Disorders, Diabetes Mellitus Risk
What is being tested?: Nutrition/substance use prevention, Substance use prevention only and Academic success program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 844 participants
Where: 1 siteUnited States
Study dates: 26 Sep 2018to 31 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Arizona State University
Phoenix, Arizona, 85004

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Diet Modification, Substance Use Disorders, Diabetes Mellitus Risk, Cardiovascular Risk Factor, Lifestyle Risk Reduction, Parenting
Being tested: Nutrition/substance use prevention, Substance use prevention only, Academic success program
Medical subject headings: Substance-Related Disorders, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nutrition/substance use preventionBehavioural
Also called FPNG+
Parenting program focusing on diet improvement and substance use prevention
Substance use prevention onlyBehavioural
Also called FPNG
Parenting program focusing only on substance use prevention
Academic success programBehavioural
Also called Realizing the American Dream (RAD)
Program focusing on academic success and college acceptance

Study groups in NCT03517111
Study group	Role	What they receive
Nutrition/substance use prevention	Experimental	Parenting and nutrition curriculum targeting substance use prevention and diet improvement. Receives: Behavioral: Nutrition/substance use prevention
Substance use prevention only	Active comparator	Parenting curriculum targeting substance use prevention only. Receives: Behavioral: Substance use prevention only
Academic success program	Sham comparator	Control program focused only on academic success. Receives: Behavioral: Academic success program

What is being measured

The primary outcome is the main question the study is designed to answer.

Adolescent Recent Alcohol Intake Frequency
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
Measured: (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26
Adolescent Recent Alcohol Intake Amount
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
Measured: (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26
Drug Resistance Strategies
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).
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Self-efficacy for Parenting Index
A measure of parental beliefs that he/she is capable of performing parental roles/responsibilities
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parents' Social Support
Social Support Questionnaire score, scale from 1 to 7. Higher scores mean more social support.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent Self-agency
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.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Overall Family Functioning- Parental Monitoring Subscale
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).
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Overall Family Functioning- Parental Involvement
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.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Overall Family Functioning- Family Support
Survey questions (parents) measuring: Change in family support,
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Overall Family Functioning: Family Conflict
Sub-scale measuring family conflict.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Overall Family Functioning- Familism
Survey questions (parents) measuring familism subscale.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Acculturation- Mexican Orientation Scale
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.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Acculturation- Anglo Orientation Subscale
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.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
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.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Nutrition Outcomes- Fruit Intake
NCI Dietary Screener: Change in intake of fruit- estimated cups per day
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Nutrition Outcomes-vegetables
NCI Dietary Screener: Change in intake of vegetables- estimated cups per day
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Nutrition Outcomes-sugar-laden Foods
NCI Dietary Screener: Change in intake of added sugars- estimated teaspoons per day
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Child Feeding Questionnaire- Weight-related Outcomes
3 item subscale measuring how often parents discussed certain weight-related topics with their adolescent (1=Never or rarely; 5=Almost every day).
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Child Feeding Questionnaire- Health-related Outcomes
3 item subscale measuring how often parents discussed certain health-related topics with their adolescent (1=Never or rarely; 5=Almost every day).
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Food Insecurity
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.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Secondary outcomes (21)

Body Weight (kg)
Measured body weight in kilograms (kg) for parents and youth. Calculated by taking the average of 3 consecutive weight readings.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Height
Measured height for parents and youth in centimeters. Calculated by taking the average of three consecutive readings.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Body Mass Index for Parents
Calculated BMI (body max index) for parents estimated by dividing weight (in kg) by height (in m) squared, with the unit of measure being kg/m^2. Typically, 18.5-24.9 is considered healthy weight; 25.0-29.9 is overweight; and equal or greater than 30.0 indicates obesity.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Systolic Blood Pressure
Measured systolic blood pressure using an automated blood pressure monitor. Calculated by taking the average of three consecutive measures. Normal range is less than 120mm Hg (units of millimeters of mercury).
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Diastolic Blood Pressure
Measured diastolic blood pressure using an automated blood pressure monitor. Calculated by taking the average of three consecutive measures. Normal range is less than 80 mmHg (units of millimeters of mercury).
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Total Cholesterol
Total cholesterol measured via finger prick blood sample. Total cholesterol is measured in milligrams of cholesterol per deciliter of blood. Scores 200 mg/dL and over are considered high.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Glycosylated Hemoglobin (HbA1c)
HbA1c measured via finger prick blood sample using a point of care device; this measures the average blood sugar levels over the past 3 months. For people without diabetes, the normal range for the hemoglobin A1c level is between 4% and 5.6%.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet- Total Energy (kcal)
Total energy from food (kcal) based off 24 hour food recalls
Measured: Week 0 (t1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet- Total Dietary Fiber (g)
Total dietary fiber in grams, based on 24 hour food recalls.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Home Food Environment - Vegetable Availability
Modified version of the validated Home Food Inventory with cultural adaptations including foods commonly consumed by Latinos used to inventory number of different vegetable items present in the home. Reporting on variable: # of vegetable items present in the home.
Measured: Week 0 (Time 1), Week 10-12 (T2), Week 24-26 (T3)
BMI % for Youth
BMI percentile, expressing a child's BMI relative to US children who participated in national surveys from 1963-65 to 1988-94. Typically, weight status categories are as follows: healthy weight is considered 5th percentile to less than the 85th percentile; 85th to less than the 95th percentile indicates overweight, and above the 95th percentile indicates obesity.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet - % Calories From Fat
Percentage of daily calories that come from fat
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet - % Calories From Carbs
Percentage of daily calories that come from carbohydrate sources
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet - % Calories From Protein
Percentage of daily calories that come from protein sources
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet - % Calories From Saturated Fats
Percentage of daily calories that come from saturated fat sources
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet - % Calories From Monounsaturated Fats
Percentage of daily calories that come from monounsaturated fat sources (MUFA).
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet - % Calories From Polyunsaturated Fats
Percentage of daily calories that come from polyunsaturated fat sources (PUFA).
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet - Total Sugars (g)
Total sugars in daily diet, measured in grams.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet - Added Sugars (g)
Total added sugars in daily diet, measured in grams. This does not include foods like fruit, with naturally occurring sugars.
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet - Whole Grains (oz)
Total whole grains in daily diet, measured in ounce equivalents (oz).
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Parent and Adolescent Diet - Refined Grains (oz)
Total refined grains in daily diet, measured in ounce equivalents (oz).
Measured: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 201831 Mar 2022

First posted7 May 2018
Study start26 Sep 2018
Primary completion31 Mar 2022
Study completion31 Mar 2022

Why it stopped: Inability to interact with participants for intervention or data collection due to COVID-19 quarantine and social distancing restrictions.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Diet ModificationStudies of the same condition, open and under way.
More trials run by Arizona State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 844 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03517111
Sponsor's protocol ID: ASU6797
Other IDs: 2U54MD002316-11
Acronym: FPNG+
Status last verified: Feb 2024
First submitted: 22 Mar 2018
Last updated: 26 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 31843638
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.
PubMed 36617277
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.
PubMed 36796757
Martinez GM, Vega-Lopez S, Ayers S, Gonzalvez A, Bruening M, Vega-Luna B, Marsiglia FF. Associations between parent-adolescent health-related conversations and mealtime media use among Hispanic families. Fam Syst Health. 2024 Jun;42(2):226-238. doi: 10.1037/fsh0000855. Epub 2023 Oct 23.
PubMed 37870808

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy

All Diet Modification trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-level Effects of a Parenting Intervention for Enhancing Latino Youth Health Behaviors
ClinicalTrials.gov ID: NCT03517111
Acronym / sponsor ID: FPNG+ / ASU6797
Conditions: Diet Modification, Substance Use Disorders, Diabetes Mellitus Risk, Cardiovascular Risk Factor, Lifestyle Risk Reduction, Parenting
Study type: Interventional
Recruitment status: TerminatedReason stopped: Inability to interact with participants for intervention or data collection due to COVID-19 quarantine and social distancing restrictions.
Enrolment: 844 participants (actual)
Lead sponsor: Arizona State UniversityUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 26 Sep 2018 (actual)
Primary completion: 31 Mar 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 7 May 2018 (actual)
Results: Posted 26 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
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.

Arm	Type	Receives
Nutrition/substance use prevention	Experimental	Behavioral: Nutrition/substance use preventionParenting and nutrition curriculum targeting substance use prevention and diet improvement.
Substance use prevention only	Active comparator	Behavioral: Substance use prevention onlyParenting curriculum targeting substance use prevention only.
Academic success program	Sham comparator	Behavioral: Academic success programControl program focused only on academic success.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nutrition/substance use preventionAlso: FPNG+Parenting program focusing on diet improvement and substance use prevention	Behavioural	Nutrition/substance use prevention
Substance use prevention onlyAlso: FPNGParenting program focusing only on substance use prevention	Behavioural	Substance use prevention only
Academic success programAlso: Realizing the American Dream (RAD)Program focusing on academic success and college acceptance	Behavioural	Academic success program

Primary outcome

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
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
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).
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.
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- 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.
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.
Overall Family Functioning- Familism
Time frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Survey questions (parents) measuring familism subscale.
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.
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.
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
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
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).
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.

21 secondary outcomes

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

Results and safety

Results posted to the registry on 26 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nutrition/Substance Use Prevention	361	361
Substance Use Prevention Only	222	221
Academic Success Program	261	261

Primary outcome: Adolescent Recent Alcohol Intake Frequency

Time frame: (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26. Mean (Standard Deviation). Unit: score on a scale

Measure	Nutrition/Substance Use Prevention n = 143	Substance Use Prevention Only n = 95	Academic Success Program n = 107
T1 (Week 0)	0.05 (0.25)	0.14 (0.66)	0.1 (0.41)
T2 (Weeks 10-12)	0.06 (0.28)	0.18 (0.83)	0.05 (0.23)
T3 (Weeks 24-26)	0.03 (0.18)	0.12 (0.83)	0.09 (0.41)

Population analysed: Only adolescent participants were included in the analysis

Primary outcome: Adolescent Recent Alcohol Intake Amount

Time frame: (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26. Mean (Standard Deviation). Unit: score on a scale

Measure	Nutrition/Substance Use Prevention n = 145	Substance Use Prevention Only n = 96	Academic Success Program n = 107
T1 (Week 0)	0.01 (0.08)	0.11 (0.56)	0.12 (0.54)
T2 (Weeks 10-12)	0.00 (0.00)	0.14 (0.82)	0.05 (0.23)
T3 (Weeks 24-26)	0.03 (0.18)	0.11 (0.82)	0.01 (0.12)

Population analysed: Only adolescent participants were included in the analysis

Primary outcome: Drug Resistance Strategies

Time frame: Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3). Mean (Standard Deviation). Unit: score on a scale

Measure	Nutrition/Substance Use Prevention n = 106	Substance Use Prevention Only n = 55	Academic Success Program n = 78	All Conditions n = 239
Baseline (T1) drug resistance strategies	1.1157 (1.43786)	1.3364 (1.78485)	1.2695 (1.5919)	1.2177 (1.57104)
T2 drug resistance strategies	.7321 (1.11529)	.9273 (1.50745)	1.1853 (1.79173)	.9294 (1.47036)
T3 drug resistance strategies	.7445 (1.34628)	.9314 (1.68751)	.7874 (1.49095)	.8037 (1.47654)
Baseline (T1) intentions to use substances (higher score=higher intention)	1.0947 (.25029)	1.2045 (.44381)	1.1526 (.96982)	1.1394 (.34513)
T2 intentions to use substances (higher score=higher intention)	1.1046 (.30865)	1.1545 (.35516)	1.1809 (.41553)	1.1419 (.35825)
T3 intentions to use substances (higher score=higher intention)	1.0914 (.25746)	1.1179 (.30463)	1.1739 (.50239)	1.1244 (.36403)

Population analysed: Participants could skip questions; additionally, some participants didn't complete all three waves of data collection.

Primary outcome: Self-efficacy for Parenting Index

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

Population analysed: This outcome measure was removed from the survey, thus, there is no data to report.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were monitored and up to the T3 data collection time point (i.e., 24-26 weeks post intervention start) for each cohort of participants.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nutrition/Substance Use Prevention	0 of 361 (0%)	0 of 361 (0%)	0 of 361
Substance Use Prevention Only	0 of 222 (0%)	0 of 222 (0%)	0 of 222
Academic Success Program	0 of 261 (0%)	0 of 261 (0%)	0 of 261

Limitations and caveats (from the sponsor): Enrollment numbers were smaller due to cancellations caused by social distancing restrictions caused by the global pandemic after March of 2020.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31843638Vega-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.
Background: PubMed 36617277Mercado 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.
Results publication: PubMed 36796757Masek 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.
Derived from this study: PubMed 37870808Martinez GM, Vega-Lopez S, Ayers S, Gonzalvez A, Bruening M, Vega-Luna B, Marsiglia FF. Associations between parent-adolescent health-related conversations and mealtime media use among Hispanic families. Fam Syst Health. 2024 Jun;42(2):226-238. doi: 10.1037/fsh0000855. Epub 2023 Oct 23.

Related trials for Diet Modification

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Flavio F Marsiglia, PhD principal investigator

Southwest Interdisciplinary Research Center, Arizona State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adolescent Recent Alcohol Intake Frequency (time frame: (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03517111, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.