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| ID | Type | Description | Link |
|---|---|---|---|
| R21DK117345 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaping and Obesity Prevention Only | Active Comparator | Obesity prevention and vaping
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| Health Literacy and Obesity Prevention | Experimental | Obesity prevention and health literacy (HL).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obesity Prevention | Behavioral | This intervention includes content specific to obesity behaviors-related health information, motivation, and behavioral skills. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 months |
| Participants' Interactive Health Literacy Assessed Using the Assessments of Adolescent Health Literacy Scales |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sasha A Fleary, PhD | City University of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CUNY Graduate School of Public Health and Health Policy | New York | New York | 10027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35972787 | Derived | 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. |
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8 participants did not complete the pretest survey 3 did not begin online intervention after completing the survey
Location: New York, Massachusetts Settings: Libraries, schools Methods: Flyers, word of mouth, tabling Length of recruitment: 6 months
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group: Health Literacy and Obesity Prevention | Obesity prevention and health literacy (HL).
|
| FG001 | Comparison Group: Vaping and Obesity Prevention Only | Obesity prevention and vaping
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants were randomly assigned, alternating between groups as they enrolled in the study. The uneven distribution is due to drop out pre-initiation of intervention participation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group: Health Literacy and Obesity Prevention | Obesity prevention and health literacy (HL).
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Self-reported age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures or incomplete data. | Posted | Count of Participants | Participants | 5 months |
|
From enrollment to end of follow-up, up to 5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group: Health Literacy and Obesity Prevention | Obesity prevention and health literacy (HL).
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sasha A Fleary | CUNY Graduate School of Public Health and Health Policy | 6463640282 | sasha.fleary@sph.cuny.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2026 | Mar 23, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D009043 | Motor Activity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D057220 | Health Literacy |
| ID | Term |
|---|---|
| D054626 | Consumer Health Information |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
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| Health Literacy | Behavioral | This intervention includes content specific to improving health literacy. |
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Percentage of participants with maintenance at max score or improvement in objective assessment of interactive health literacy |
| 5 months |
| 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 | 5 months |
| 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 | 5 months |
| 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) | 5 months |
| BG001 | Comparison Group: Vaping and Obesity Prevention Only | Obesity prevention and vaping
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| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Self-reported sex | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Self-reported race/ethnicity | Count of Participants | Participants |
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| Region of Enrollment | Country of study | Number | Participants |
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| Assessments of Adolescent Health Literacy Scales composite health literacy score | Baseline composite health literacy: total score on a test of functional, interactive, and critical health literacy. Scores range from 0-29. Higher values represent higher health literacy. | Mean | Standard Deviation | Score range from 0-29 |
|
| OG001 | Comparison Group: Vaping and Obesity Prevention Only | Obesity prevention and vaping
|
|
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| Primary | 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 | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures or incomplete data. | Posted | Count of Participants | Participants | 5 months |
|
|
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| Primary | 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 | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures or incomplete data. | Posted | Count of Participants | Participants | 5 months |
|
|
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| Primary | 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 | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures or incomplete data. | Posted | Count of Participants | Participants | 5 months |
|
|
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| Primary | 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 | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures. | Posted | Count of Participants | Participants | 5 months |
|
|
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| Secondary | 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 | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures. One participant had incomplete data on functional health literacy measures. | Posted | Count of Participants | Participants | 5 months |
|
|
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| Secondary | 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 | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures. One participant had incomplete data on interactive health literacy measures. | Posted | Count of Participants | Participants | 5 months |
|
|
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| Secondary | 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 | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures. Two participants had incomplete data on critical health literacy measures. | Posted | Count of Participants | Participants | 5 months |
|
|
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| Secondary | 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 | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures. One participant had incomplete data on media health literacy measures. | Posted | Count of Participants | Participants | 5 months |
|
|
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| Secondary | 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) | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures. Two participants had incomplete data on health literacy measures. | Posted | Count of Participants | Participants | 5 months |
|
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| Primary | 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 | The difference in the numbers from baseline is due to attrition. Two participants were excluded due to erratic responses, 4 was lost due to non-completion of the intervention, and 2 were lost due to non-completion of posttest and follow-up measures or incomplete data. | Posted | Count of Participants | Participants | 5 months |
|
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|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Comparison Group: Vaping and Obesity Prevention Only | Obesity prevention and vaping
| 0 | 12 | 0 | 12 | 0 | 12 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005159 | Health Care Facilities Workforce and Services |