Shape Up Kids Fitness Ancillary
- Conditions
- Childhood Obesity
- Registration Number
- NCT03624582
- Lead Sponsor
- Pennington Biomedical Research Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Eligible for the Shape Up Kids primary study
- Height ≥ 4 feet 8 inches
- Body weight < 350 lbs
- American College of Sports Medicine (ACSM) contraindications to exercise testing (i.e., medical history of cardiovascular or pulmonary conditions, physical conditions that affect the ability to exercise)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time 1 APA bias scores Day 0 / Primary Study Visit 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 2 APA bias scores 8-21 days after Primary Study Visit 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.
Habitual physical and sedentary activity 7 days between visits 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.
Free-choice play period 8-21 days after Primary Study Visit 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.
- Secondary Outcome Measures
Name Time Method Cardiorespiratory fitness 8-21 days after Primary Study Visit Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
Body composition 1 Day 0 / Primary Study Visit In the Shape Up Kids primary study, body composition is measured using bioelectrical impedance analysis (BIA).
Body composition 2 Day 0 / Primary Study Visit In the Shape Up Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).
Body composition 3 Day 0 / Primary Study Visit In the Shape Up Kids primary study, body composition is measured using whole-body magnetic resonance imaging (MRI).
Physical strength Day 0 / Primary Study Visit In the Shape Up Kids primary study, physical strength is assessed with dynamometers.
Resting blood pressure Day 0 / Primary Study Visit In the Shape Up Kids primary study, blood pressure is assessed after 5 minutes of rest.
Resting heart rate Day 0 / Primary Study Visit In the Shape Up Kids primary study, heart rate is assessed after 5 minutes of rest.
Cardiometabolic disease biomarkers Day 0 / Primary Study Visit 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 1 activity liking and wanting Visual Analog Scale (VAS) scores Day 0 / Primary Study Visit 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 2 activity liking and wanting VAS scores 8-21 days after Primary Study Visit 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"
Trial Locations
- Locations (1)
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States