Shape Up Kids Fitness Ancillary

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624582
• Other study ID #: 2018-028
• Secondary ID: P30DK072476
• Status: Completed
• Start date: July 2, 2018
• Est. completion date: December 17, 2020

Study information

• Verified date: June 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 17, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	8-21 days after Primary Study Visit
Other	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.	8-21 days after Primary Study Visit
Other	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.	8-21 days after Primary Study Visit
Other	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.	8-21 days after Primary Study Visit
Other	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.	8-21 days after Primary Study Visit
Primary	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.	Day 0 / Primary Study Visit
Primary	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.	8-21 days after Primary Study Visit
Primary	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.	7 days between visits
Primary	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.	8-21 days after Primary Study Visit
Secondary	Cardiorespiratory fitness	Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.	8-21 days after Primary Study Visit
Secondary	Body composition 1	In the Shape Up Kids primary study, body composition is measured using bioelectrical impedance analysis (BIA).	Day 0 / Primary Study Visit
Secondary	Body composition 2	In the Shape Up Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).	Day 0 / Primary Study Visit
Secondary	Body composition 3	In the Shape Up Kids primary study, body composition is measured using whole-body magnetic resonance imaging (MRI).	Day 0 / Primary Study Visit
Secondary	Physical strength	In the Shape Up Kids primary study, physical strength is assessed with dynamometers.	Day 0 / Primary Study Visit
Secondary	Resting blood pressure	In the Shape Up Kids primary study, blood pressure is assessed after 5 minutes of rest.	Day 0 / Primary Study Visit
Secondary	Resting heart rate	In the Shape Up Kids primary study, heart rate is assessed after 5 minutes of rest.	Day 0 / Primary Study Visit
Secondary	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.	Day 0 / Primary Study Visit
Secondary	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"	Day 0 / Primary Study Visit
Secondary	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"	8-21 days after Primary Study Visit