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Shape Up Kids Fitness Ancillary

Validity and Reliability of the Activity Preference Assessment: A Shape Up Kids Ancillary

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03624582
Enrollment
60
Registered
2018-08-10
Start date
2018-07-02
Completion date
2020-12-17
Last updated
2022-06-21

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

Conditions

Childhood Obesity

Keywords

Cardiorespiratory fitness, Sedentary behavior, Physical activity, Decision-making, Cardiometabolic risk factors

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.

Interventions

None listed

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Louisiana State University, Baton Rouge
CollaboratorOTHER
University of Leeds
CollaboratorOTHER
Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

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

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)

Design outcomes

Primary

MeasureTime frameDescription
Free-choice play period8-21 days after Primary Study VisitChildren 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.
Habitual physical and sedentary activity7 days between visitsPhysical 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 2 APA bias scores8-21 days after Primary Study VisitBias 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 1 APA bias scoresDay 0 / Primary Study VisitBias 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.

Secondary

MeasureTime frameDescription
Body composition 3Day 0 / Primary Study VisitIn the Shape Up Kids primary study, body composition is measured using whole-body magnetic resonance imaging (MRI).
Physical strengthDay 0 / Primary Study VisitIn the Shape Up Kids primary study, physical strength is assessed with dynamometers.
Cardiorespiratory fitness8-21 days after Primary Study VisitCardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
Body composition 1Day 0 / Primary Study VisitIn the Shape Up Kids primary study, body composition is measured using bioelectrical impedance analysis (BIA).
Body composition 2Day 0 / Primary Study VisitIn the Shape Up Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).
Resting blood pressureDay 0 / Primary Study VisitIn the Shape Up Kids primary study, blood pressure is assessed after 5 minutes of rest.
Resting heart rateDay 0 / Primary Study VisitIn the Shape Up Kids primary study, heart rate is assessed after 5 minutes of rest.
Cardiometabolic disease biomarkersDay 0 / Primary Study VisitIn 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) scoresDay 0 / Primary Study VisitParticipants 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 scores8-21 days after Primary Study VisitParticipants 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

Other

MeasureTime frameDescription
International Sedentary Assessment Tool8-21 days after Primary Study VisitChildren 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.
Mood and Feelings Questionnaire8-21 days after Primary Study VisitChildren 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.
Neighborhood and home environment survey8-21 days after Primary Study VisitParents will describe environmental factors through a neighborhood and home environment survey. Selected items from this survey will be used as covariates in analyses.
Body Esteem Scale8-21 days after Primary Study VisitChildren 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.
Physical Self Description Scale8-21 days after Primary Study VisitChildren 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026