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Obesity, AdolescentHL-SquaredNCT04252677

Health Literacy and Obesogenic Behaviors

A study testing Obesity Prevention and Health Literacy in people with Obesity, Adolescent and Health Behavior, run by City University of New York, School of Public Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 17 yearsHealthy volunteers can take part
What is being tested?
Obesity Prevention and Health Literacy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
16 Nov 2022to 30 Dec 2024
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 13 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • CUNY Graduate School of Public Health and Health Policy

    New York, New York, 10027

Other trials in United States

About this study

Official title: Health Literacy as a Vehicle to Reduce Obesogenic Behaviors Among Adolescents: A Pilot Intervention

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.

Read the detailed description

The rates of pediatric obesity (~19%) and diabetes (0.24%) in the US are alarming and behaviors implicated in obesity and type 2 diabetes are highly prevalent. Approximately 69% and 73% of adolescents consume less than two fruits and vegetables daily respectively, while 53% engage in insufficient physical activity. These behaviors magnify adolescents' immediate and long-term risks for obesity and obesity-related chronic illnesses, as well as complicate the treatment of obesity-related chronic illnesses. Children and adolescents who are obese are four times more likely to be diagnosed with type 2 diabetes than normal weight children, with serious short and long-term consequences impacting quality of life. Reduced life expectancy is the future of America's youth if behavioral changes are not implemented to improve health and reduce the obesity burden. Reversing current national trends in obesity and type 2 diabetes require novel and sustainable prevention strategies to address children and adolescents' obesogenic behaviors.

Adolescence is marked by increased autonomy in decision-making, yet data suggest that adolescents are not equipped with all the skills to make effective health-related behavioral decisions. While health knowledge works in conjunction with motivation and behavioral skills to predict behavior, most existing adolescent interventions target these variables in isolation with modest success. Researchers have argued that health literacy (HL) - the ability to access, understand, and use health information to make informed health decisions - is a precursor to health knowledge and is necessary for translating health knowledge into behavior. Low HL among adults is associated with poor ability to interpret health messages, and results in reduced preventive health behaviors. Further, parent and adolescent HL is negatively related to adolescents' obesity status. Thus, while research on adding HL to existing behavior interventions to improve adolescents' obesity prevention behaviors is lacking, it is expected that the inclusion of HL into existing interventions will increase intervention effectiveness and positive behavior outcomes.

The long-term goal of this line of research is to reduce the incidence of obesity in adolescents and by extension reduce the risk for obesity-related chronic illnesses using interventions that address individual and contextual factors related to long-term health decision-making and behavior change. The goal of the proposed study is to examine the effect of adding a HL component to an obesity prevention intervention that addresses adolescents' obesogenic behavior-related health knowledge, motivation, and behavioral skills. The central hypothesis is adolescents receiving HL training as part of an obesity prevention intervention will have higher rates of prevention behaviors than those in the obesity prevention only condition. Study goals will be achieved through the following specific aims:

Aim 1: Modify successful components of existing obesity prevention interventions into an interactive digital platform with and without HL for acceptability and usability in adolescents.

Approach: Use successful components of existing interventions, our completed preliminary research, and our research teams' expertise to develop an interactive digital intervention including HL, and obesogenic behavior-related health knowledge, motivation, and behavioral skills. Assess and modify the intervention for usability and acceptability among 14-16-year-olds through an iterative process.

Aim 2: Determine if the addition of HL training to an interactive digital obesity prevention intervention will improve adolescents' obesity prevention behaviors over the obesity intervention alone.

Hypothesis: Adolescents in the obesity prevention plus HL intervention will have higher rates of obesity prevention behaviors at posttest and follow-up compared to the obesity prevention only group.

Approach: Conduct a two-arm randomized controlled trial (RCT) intervention (obesity prevention only, obesity prevention/HL) and estimate the intervention's effects on obesogenic behaviors. Adolescents (n = 36; 14-16-year-olds) will be randomly assigned to each condition (18/condition). Conduct pretest, posttest, and 1- month assessments of HL, obesogenic behaviors, and obesogenic behavior-related motivation, behavioral skills, and knowledge.

Outcomes: Intervention completion will result in effect size estimates of improvements in obesity prevention behaviors, health knowledge, motivation, and behavioral skills for both groups with greater improvements for the HL group at posttest and follow-up. The obesity prevention/HL intervention group will also have higher HL at posttest and follow-up. Retention, recruitment, completion and treatment fidelity rates will be established.

Innovation \& Impact: This study incorporates HL, an understudied but potentially critical factor in adolescents' health behaviors. The intervention will be developed and implemented in a digital format which will increase reach and impact. This is the first study examining the effect of including HL in adolescents' obesity prevention interventions. This study sets the groundwork for a full scale, RCT to assess the benefit of HL training added to an obesity prevention intervention to address adolescents' obesogenic behaviors.

Being tested
Obesity Prevention, Health Literacy
Keywords
health literacy, obesity, diet, physical activity, information-motivation-behavioral skills model, adolescent
Medical subject headings
Pediatric Obesity, Health Behavior, Behavior, Motor Activity, Obesity

What participants receive

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

  • Obesity PreventionBehavioural

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

  • Health LiteracyBehavioural

    This intervention includes content specific to improving health literacy.

Study groups in NCT04252677
Study groupRoleWhat they receive
Vaping and Obesity Prevention OnlyActive comparatorObesity 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
Receives: Behavioral: Obesity Prevention
Health Literacy and Obesity PreventionExperimentalObesity 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
Receives: Behavioral: Obesity Prevention; Behavioral: Health Literacy

What is being measured

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

  1. 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

    Measured: 5 months

  2. 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

    Measured: 5 months

  3. 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

    Measured: 5 months

  4. 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

    Measured: 5 months

  5. 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

    Measured: 5 months

  6. 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

    Measured: 5 months

Secondary outcomes (5)
  1. Participants' Functional Health Literacy Will be Assessed Using the Assessments of Adolescent Health Literacy Scales

    Percentage of participants with maintenance (at max score) or improvement in objective measure of reading and numeracy skills for health

    Measured: 5 months

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

    Percentage of participants with maintenance at max score or improvement in objective assessment of interactive health literacy

    Measured: 5 months

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

    Percentage of participants with maintenance or improvement in objective measure of social skills and critical thinking for health

    Measured: 5 months

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

    Percentage of participants with maintenance or improvement in objective measure of media literacy for health

    Measured: 5 months

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

    Percentage of participants with maintenance or improvement in objective measure of three core components of health literacy (functional, interactive, critical)

    Measured: 5 months

Timeline

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

  1. First posted5 Feb 2020
  2. Study start16 Nov 2022
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

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
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04252677
Sponsor's protocol ID
HLSQUARED01
Other IDs
R21DK117345
Acronym
HL-Squared
Status last verified
Apr 2026
First submitted
16 Jan 2020
Last updated
1 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35972787

Questions about this trial

What is this clinical trial studying?

A study testing Obesity Prevention and Health Literacy in people with Obesity, Adolescent and Health Behavior, run by City University of New York, School of Public Health at 1 site in United States.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 1 May 2026. 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. 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 1 May 2026). 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?

Improvement in Participants' Healthy Eating Behaviors as Assessed by the Dietary Screener Questionnaire and the National Youth Physical Activity and Nutrition Study (time frame: 5 months). The study lists 6 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 NCT04252677, which also lists 1 linked publication.

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 1 May 2026.

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