An observational study in Childhood Obesity, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Pennington Biomedical Research Center · Observational
The overall objective of this study is to quantify the decision-making process and underlying biases around leisure activity behaviors using the Activity Preference Assessment (APA), a novel psychological task. The investigators plan to validate the APA against objectively measured sedentary and physical activity time, and examine its potential to predict health-related outcomes in children and adolescents. The Shape Up Kids Fitness Ancillary protocol will add exercise testing, cognitive and behavioral measures, accelerometry, and questionnaires to the existing Shape Up Kids primary study dataset.
The investigators will enroll 60 boys and girls (50% female) between the ages of 8-17 years into this pilot and feasibility ancillary study. The aims of this study are to validate and test the reliability of the Activity Preference Assessment (APA), as described below.
Aim 1: To examine the convergent validity of the APA against habitual physical and sedentary activity time measured objectively by seven days of accelerometry, as well as leisure activity choices during a 30-minute free-choice play period.
Aim 2: To examine the criterion validity of the APA against concurrent measures of body composition, cardiometabolic health indicators, aerobic fitness, and physical strength.
Aim 3: To measure the test-retest reliability of APA outcomes through repeated measures separated by approximately one week.
Exploratory Aim: To investigate patterns or clusters of activity preferences through exploratory factor analysis of activity liking VAS scores.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 60 is below the median of 200 across 231 observational studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.
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This study will identify and recruit 60 participants from the Shape Up Kids primary study sample of 360 participants. Ancillary participants will be between the ages of 8-17 years. We will have an even distribution of boys (n=30) and girls (n=30) and aim to have a representative distribution of race.
Exclusion Criteria:
Time 1 APA bias scores
Bias scores are calculated from reaction times and choices made during the forced-choice section of the APA. Scores range from -100 to +100, with negative scores indicating a bias towards physical activities, and positive scores indicating a bias towards sedentary activities.
Time frame: Day 0 / Primary Study Visit
Time 2 APA bias scores
Bias scores are calculated from reaction times and choices made during the forced-choice section of the APA. Scores range from -100 to +100, with negative scores indicating a bias towards physical activities, and positive scores indicating a bias towards sedentary activities.
Time frame: 8-21 days after Primary Study Visit
Habitual physical and sedentary activity
Physical and sedentary activity time are measured for 24 hours per day over 7 consecutive days, including 2 weekend days, using ActiGraph GT3X+ accelerometers worn on the left mid-axillary line.
Time frame: 7 days between visits
Free-choice play period
Children will have 30 minutes to play freely in a room with a variety of sedentary and physical activity choices. Trained observers will record children's activity every 15 seconds.
Time frame: 8-21 days after Primary Study Visit
Cardiorespiratory fitness
Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
Time frame: 8-21 days after Primary Study Visit
Body composition 1
In the Shape Up Kids primary study, body composition is measured using bioelectrical impedance analysis (BIA).
Time frame: Day 0 / Primary Study Visit
Body composition 2
In the Shape Up Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).
Time frame: Day 0 / Primary Study Visit
Body composition 3
In the Shape Up Kids primary study, body composition is measured using whole-body magnetic resonance imaging (MRI).
Time frame: Day 0 / Primary Study Visit
Physical strength
In the Shape Up Kids primary study, physical strength is assessed with dynamometers.
Time frame: Day 0 / Primary Study Visit
Resting blood pressure
In the Shape Up Kids primary study, blood pressure is assessed after 5 minutes of rest.
Time frame: Day 0 / Primary Study Visit
Resting heart rate
In the Shape Up Kids primary study, heart rate is assessed after 5 minutes of rest.
Time frame: Day 0 / Primary Study Visit
Cardiometabolic disease biomarkers
In the Shape Up Kids primary study, fasting levels of lipid, glucose, and inflammatory biomarkers are assessed via blood draw with a single Chem 26 assay panel.
Time frame: Day 0 / Primary Study Visit
Time 1 activity liking and wanting Visual Analog Scale (VAS) scores
Participants will rate how much they like to do and want to do each of the activities included in the APA on VAS that range from 0 or "Not at all" to 100 or "Like/Want very much"
Time frame: Day 0 / Primary Study Visit
Time 2 activity liking and wanting VAS scores
Participants will rate how much they like to do and want to do each of the activities included in the APA on VAS that range from 0 or "Not at all" to 100 or "Like/Want very much"
Time frame: 8-21 days after Primary Study Visit
International Sedentary Assessment Tool
Children will fill out questionnaires regarding possible socio-emotional factors that can influence activity choices, including the International Sedentary Assessment Tool. This survey will be scored according to standard published procedures.
Time frame: 8-21 days after Primary Study Visit
Mood and Feelings Questionnaire
Children will fill out questionnaires regarding possible socio-emotional factors that can influence activity choices, including the Mood and Feelings Questionnaire (short version). This survey will be scored according to standard published procedures.
Time frame: 8-21 days after Primary Study Visit
Physical Self Description Scale
Children will fill out questionnaires regarding possible socio-emotional factors that can influence activity choices, including the Physical Self Description Scale. This survey will be scored according to standard published procedures.
Time frame: 8-21 days after Primary Study Visit
Body Esteem Scale
Children will fill out questionnaires regarding possible socio-emotional factors that can influence activity choices, including the Body Esteem Scale. This survey will be scored according to standard published procedures.
Time frame: 8-21 days after Primary Study Visit
Neighborhood and home environment survey
Parents will describe environmental factors through a neighborhood and home environment survey. Selected items from this survey will be used as covariates in analyses.
Time frame: 8-21 days after Primary Study Visit
Plan to share: No
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Pennington Biomedical Research Center