NCT04252677

Brief Summary

The prevalence of adolescent behaviors that can lead to obesity are alarming, and reduced life expectancy is the future of America's youth if behavioral changes are not implemented to improve health and reduce the obesity burden. Researchers have argued that health literacy is a precursor to health knowledge and is necessary for translating knowledge about healthy choices into behavior, with low health literacy being associated with reduced preventive health behaviors in adults. Given the lack of health literacy-specific interventions addressing adolescents' obesogenic behaviors, the purpose of this study is to examine the preliminary effectiveness of adding a health literacy module to an obesity prevention intervention that addresses adolescents' obesogenic behaviors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

November 16, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

January 16, 2020

Results QC Date

March 23, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

health literacyobesitydietphysical activityinformation-motivation-behavioral skills modeladolescent

Outcome Measures

Primary Outcomes (6)

  • Improvement in Participants' Healthy Eating Behaviors as Assessed by the Dietary Screener Questionnaire and the National Youth Physical Activity and Nutrition Study

    Percent of participants improved healthy eating (e.g., fruits and vegetables) behaviors

    5 months

  • Reductions in Participants' Unhealthy Eating Behaviors as Assessed by the Dietary Screener Questionnaire and the National Youth Physical Activity and Nutrition Study

    Percent of participants reduce unhealthy eating (sugary and salty foods, junk foods) behaviors

    5 months

  • Improvements in Participants' Physical Activity as Assessed by the Youth Activity Profile

    Percent of participants increase number of days with 60 minutes of more of physical activity

    5 months

  • Improvements in Participants' Physical Activity as Assessed by the Godin and Shephard Leisure-Time Physical Activity Questionnaire

    Percent of participants in weekly leisure activity score

    5 months

  • Reductions in Participants' Sedentary Activity as Assessed by the Youth Activity Profile

    Percent of participants with increase in number of days with less than 2 hours of sedentary behaviors

    5 months

  • Reduction in Participants' Sugar-sweetened Beverage Consumption as Measured by the Dietary Screener Questionnaire and the National Youth Physical Activity and Nutrition Study

    Percent of participants with reduced sugar-sweetened beverage intake

    5 months

Secondary Outcomes (5)

  • Participants' Functional Health Literacy Will be Assessed Using the Assessments of Adolescent Health Literacy Scales

    5 months

  • Participants' Interactive Health Literacy Assessed Using the Assessments of Adolescent Health Literacy Scales

    5 months

  • Participants' Critical Health Literacy Will be Assessed Using the Assesments of Adolescent Health Literacy Scales

    5 months

  • Participants' Media Health Literacy Will be Measured Using the Adolescent Media Health Literacy Scale and eHeals

    5 months

  • Participants' Overall Health Literacy Will be Assessed Using the Assessments of Adolescent Health Literacy Scales

    5 months

Study Arms (2)

Vaping and Obesity Prevention Only

ACTIVE COMPARATOR

Obesity prevention and vaping 1. Vaping: * Factual information about vaping devices and vaping * Beliefs and attitudes about nicotine products * Refusing and avoiding vaping * Recognizing addiction and getting help 2. Health information: • Factual information about healthy eating and activity (PA) 3. Motivation: * Personal: Create positive attitudes toward engagement in healthy eating and PA * Social: Enlisting social support to increase healthy eating and PA * Social: Identification of community resources that promote and support healthy eating and PA 4. Behavioral Skills * Tips for engaging in prevention behaviors and avoiding risk behaviors in the context of existing barriers * Skills for social situations around behaviors * Skills for making behavior part of routine * Build autonomy, self-efficacy and model good health decision-making for health behaviors

Behavioral: Obesity Prevention

Health Literacy and Obesity Prevention

EXPERIMENTAL

Obesity prevention and health literacy (HL). 1. Health Literacy * Functional HL: skills for reading/understanding nutrition labels and medication instructions. * Interactive HL: verbal skills for interacting with others on health issues. * Critical HL: connections between advocacy and health * Media HL: skills for accessing and identifying reliable source of media. 2. Health information: • Factual information about healthy eating and activity (PA) 3. Motivation: * Create positive attitudes toward engagement in healthy eating and PA * Enlisting social support to increase healthy eating and PA * Identification of community resources that promote and support healthy eating and PA 4. Behavioral Skills * Tips for engaging in prevention behaviors and avoiding risk behaviors * Skills for social situations around behaviors * Skills for making behavior part of routine * Build autonomy, self-efficacy and good health decision-making for health behaviors

Behavioral: Obesity PreventionBehavioral: Health Literacy

Interventions

This intervention includes content specific to obesity behaviors-related health information, motivation, and behavioral skills.

Health Literacy and Obesity PreventionVaping and Obesity Prevention Only
Health LiteracyBEHAVIORAL

This intervention includes content specific to improving health literacy.

Health Literacy and Obesity Prevention

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents 13-16 years old at time of enrollment (may turn age 17 during the study
  • Must have parental consent
  • All weight classifications

You may not qualify if:

  • Adolescents younger than 13 years or older than 16 years at time of enrollment
  • No parental consent
  • Medical conditions preventing engagement in physical activity
  • Medical conditions resulting in extremely restricted diets (e.g., ketogenic diet)
  • Already participating in an intervention related to healthy eating, physical activity and/or obesity prevention or treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUNY Graduate School of Public Health and Health Policy

New York, New York, 10027, United States

Location

Related Publications (1)

  • Fleary SA. A Web-Based Intervention to Improve Health Literacy and Obesogenic Behaviors Among Adolescents: Protocol of a Randomized Pilot Feasibility Study for a Parallel Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 16;11(8):e40191. doi: 10.2196/40191.

MeSH Terms

Conditions

Pediatric ObesityHealth BehaviorBehaviorMotor ActivityObesity

Interventions

Health Literacy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Consumer Health InformationHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Sasha A Fleary
Organization
CUNY Graduate School of Public Health and Health Policy

Study Officials

  • Sasha A Fleary, PhD

    City University of New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 16, 2020

First Posted

February 5, 2020

Study Start

November 16, 2022

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

May 1, 2026

Results First Posted

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations