Clinical trial NCT03624582: Shape Up Kids Fitness Ancillary
Official title: Validity and Reliability of the Activity Preference Assessment: A Shape Up Kids Ancillary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Keywords: Cardiorespiratory fitness
Sedentary behavior
Physical activity
Decision-making
Cardiometabolic risk factors
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Louisiana State University, Baton Rouge
name: University of Leeds
First posted: 2018-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time 1 APA bias scores
timeFrame: Day 0 / Primary Study Visit
measure: Time 2 APA bias scores
timeFrame: 8-21 days after Primary Study Visit
measure: Habitual physical and sedentary activity
timeFrame: 7 days between visits
measure: Free-choice play period
timeFrame: 8-21 days after Primary Study Visit
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: 8-21 days after Primary Study Visit
measure: Body composition 1
timeFrame: Day 0 / Primary Study Visit
measure: Body composition 2
timeFrame: Day 0 / Primary Study Visit
measure: Body composition 3
timeFrame: Day 0 / Primary Study Visit
measure: Physical strength
timeFrame: Day 0 / Primary Study Visit
measure: Resting blood pressure
timeFrame: Day 0 / Primary Study Visit
measure: Resting heart rate
timeFrame: Day 0 / Primary Study Visit
measure: Cardiometabolic disease biomarkers
timeFrame: Day 0 / Primary Study Visit
measure: Time 1 activity liking and wanting Visual Analog Scale (VAS) scores
timeFrame: Day 0 / Primary Study Visit
measure: Time 2 activity liking and wanting VAS scores
timeFrame: 8-21 days after Primary Study Visit
Other outcomes:
measure: International Sedentary Assessment Tool
timeFrame: 8-21 days after Primary Study Visit
measure: Mood and Feelings Questionnaire
timeFrame: 8-21 days after Primary Study Visit
measure: Physical Self Description Scale
timeFrame: 8-21 days after Primary Study Visit
measure: Body Esteem Scale
timeFrame: 8-21 days after Primary Study Visit
measure: Neighborhood and home environment survey
timeFrame: 8-21 days after Primary Study Visit
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: S. Nicole Fearnbach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fearnbach SN, Martin CK, Heymsfield SB, Staiano AE, Newton RL Jr, Garn AC, Johannsen NM, Hsia DS, Carmichael OT, Ramakrishnapillai S, Murray KB, Blundell JE, Finlayson G. Validation of the Activity Preference Assessment: a tool for quantifying children's implicit preferences for sedentary and physical activities. Int J Behav Nutr Phys Act. 2020 Aug 24;17(1):108. doi: 10.1186/s12966-020-01014-6.