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Health Literacy and Obesogenic Behaviors

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04252677
Acronym
HL-Squared
Enrollment
36
Registered
2020-02-05
Start date
2022-11-16
Completion date
2024-12-30
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Healthy, Exercise, Health Behavior, Health Knowledge, Attitudes, Practice, Health Literacy, Obesity, Adolescent

Keywords

health literacy, obesity, diet, physical activity, information-motivation-behavioral skills model, adolescent

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.

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.

Interventions

BEHAVIORALObesity Prevention

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

BEHAVIORALHealth Literacy

This intervention includes content specific to improving health literacy.

Sponsors

City University of New York, School of Public Health
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in Participants' Healthy Eating Behaviors as Assessed by the Dietary Screener Questionnaire and the National Youth Physical Activity and Nutrition Study5 monthsPercent of participants improved healthy eating (e.g., fruits and vegetables) behaviors
Reductions in Participants' Unhealthy Eating Behaviors as Assessed by the Dietary Screener Questionnaire and the National Youth Physical Activity and Nutrition Study5 monthsPercent of participants reduce unhealthy eating (sugary and salty foods, junk foods) behaviors
Improvements in Participants' Physical Activity as Assessed by the Youth Activity Profile5 monthsPercent of participants increase number of days with 60 minutes of more of physical activity
Improvements in Participants' Physical Activity as Assessed by the Godin and Shephard Leisure-Time Physical Activity Questionnaire5 monthsPercent of participants in weekly leisure activity score
Reductions in Participants' Sedentary Activity as Assessed by the Youth Activity Profile5 monthsPercent of participants with increase in number of days with less than 2 hours of sedentary behaviors
Reduction in Participants' Sugar-sweetened Beverage Consumption as Measured by the Dietary Screener Questionnaire and the National Youth Physical Activity and Nutrition Study5 monthsPercent of participants with reduced sugar-sweetened beverage intake

Secondary

MeasureTime frameDescription
Participants' Functional Health Literacy Will be Assessed Using the Assessments of Adolescent Health Literacy Scales5 monthsPercentage of participants with maintenance (at max score) or improvement in objective measure of reading and numeracy skills for health
Participants' Interactive Health Literacy Assessed Using the Assessments of Adolescent Health Literacy Scales5 monthsPercentage of participants with maintenance at max score or improvement in objective assessment of interactive health literacy
Participants' Critical Health Literacy Will be Assessed Using the Assesments of Adolescent Health Literacy Scales5 monthsPercentage of participants with maintenance or improvement in objective measure of social skills and critical thinking for health
Participants' Media Health Literacy Will be Measured Using the Adolescent Media Health Literacy Scale and eHeals5 monthsPercentage of participants with maintenance or improvement in objective measure of media literacy for health
Participants' Overall Health Literacy Will be Assessed Using the Assessments of Adolescent Health Literacy Scales5 monthsPercentage of participants with maintenance or improvement in objective measure of three core components of health literacy (functional, interactive, critical)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSasha A Fleary, PhD

City University of New York

Participant flow

Recruitment details

Location: New York, Massachusetts Settings: Libraries, schools Methods: Flyers, word of mouth, tabling Length of recruitment: 6 months

Pre-assignment details

8 participants did not complete the pretest survey 3 did not begin online intervention after completing the survey

Baseline characteristics

Characteristic
Age, Continuous15.68 Years
STANDARD_DEVIATION 1.77
Assessments of Adolescent Health Literacy Scales composite health literacy score24.67 Score range from 0-29
STANDARD_DEVIATION 4.56
Race/Ethnicity, Customized
Asian
5 Participants
Race/Ethnicity, Customized
Black
7 Participants
Race/Ethnicity, Customized
Hispanic
1 Participants
Race/Ethnicity, Customized
White
0 Participants
Region of Enrollment
United States
13 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 12
other
Total, other adverse events
0 / 130 / 12
serious
Total, serious adverse events
0 / 130 / 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026