- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624582
Shape Up Kids Fitness Ancillary
Validity and Reliability of the Activity Preference Assessment: A Shape Up Kids Ancillary
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Eligible for the Shape Up Kids primary study
- Height ≥ 4 feet 8 inches
- Body weight < 350 lbs
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time 1 APA bias scores
Time Frame: Day 0 / Primary Study Visit
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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.
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Day 0 / Primary Study Visit
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Time 2 APA bias scores
Time Frame: 8-21 days after Primary Study Visit
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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.
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8-21 days after Primary Study Visit
|
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Habitual physical and sedentary activity
Time Frame: 7 days between visits
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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.
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7 days between visits
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Free-choice play period
Time Frame: 8-21 days after Primary Study Visit
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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.
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8-21 days after Primary Study Visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiorespiratory fitness
Time Frame: 8-21 days after Primary Study Visit
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Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
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8-21 days after Primary Study Visit
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Body composition 1
Time Frame: Day 0 / Primary Study Visit
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In the Shape Up Kids primary study, body composition is measured using bioelectrical impedance analysis (BIA).
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Day 0 / Primary Study Visit
|
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Body composition 2
Time Frame: 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).
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Day 0 / Primary Study Visit
|
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Body composition 3
Time Frame: Day 0 / Primary Study Visit
|
In the Shape Up Kids primary study, body composition is measured using whole-body magnetic resonance imaging (MRI).
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Day 0 / Primary Study Visit
|
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Physical strength
Time Frame: Day 0 / Primary Study Visit
|
In the Shape Up Kids primary study, physical strength is assessed with dynamometers.
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Day 0 / Primary Study Visit
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Resting blood pressure
Time Frame: Day 0 / Primary Study Visit
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In the Shape Up Kids primary study, blood pressure is assessed after 5 minutes of rest.
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Day 0 / Primary Study Visit
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Resting heart rate
Time Frame: Day 0 / Primary Study Visit
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In the Shape Up Kids primary study, heart rate is assessed after 5 minutes of rest.
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Day 0 / Primary Study Visit
|
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Cardiometabolic disease biomarkers
Time Frame: Day 0 / Primary Study Visit
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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.
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Day 0 / Primary Study Visit
|
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Time 1 activity liking and wanting Visual Analog Scale (VAS) scores
Time Frame: Day 0 / Primary Study Visit
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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"
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Day 0 / Primary Study Visit
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Time 2 activity liking and wanting VAS scores
Time Frame: 8-21 days after Primary Study Visit
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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"
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8-21 days after Primary Study Visit
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Sedentary Assessment Tool
Time Frame: 8-21 days after Primary Study Visit
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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.
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8-21 days after Primary Study Visit
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Mood and Feelings Questionnaire
Time Frame: 8-21 days after Primary Study Visit
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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.
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8-21 days after Primary Study Visit
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Physical Self Description Scale
Time Frame: 8-21 days after Primary Study Visit
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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.
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8-21 days after Primary Study Visit
|
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Body Esteem Scale
Time Frame: 8-21 days after Primary Study Visit
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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.
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8-21 days after Primary Study Visit
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Neighborhood and home environment survey
Time Frame: 8-21 days after Primary Study Visit
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Parents will describe environmental factors through a neighborhood and home environment survey.
Selected items from this survey will be used as covariates in analyses.
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8-21 days after Primary Study Visit
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: S. Nicole Fearnbach, PhD, Pennington Biomedical Research Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-028
- P30DK072476 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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