Shape Up Kids Fitness Ancillary

NCT03624582 | Completed

• 2 other identifiers: 2018-028P30DK072476
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (10)

• Cardiorespiratory fitness

  8-21 days after Primary Study Visit

• Body composition 1

  Day 0 / Primary Study Visit

• Body composition 2

  Day 0 / Primary Study Visit

• Body composition 3

  Day 0 / Primary Study Visit

• Physical strength

  Day 0 / Primary Study Visit

Other Outcomes (5)

• International Sedentary Assessment Tool

  8-21 days after Primary Study Visit

• Mood and Feelings Questionnaire

  8-21 days after Primary Study Visit

• Physical Self Description Scale

  8-21 days after Primary Study Visit

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Eligible for the Shape Up Kids primary study
• Height ≥ 4 feet 8 inches
• Body weight \< 350 lbs

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Louisiana State University, Baton Rouge: collaborator
• University of Leeds: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related 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.

  PMID: 32831103 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• S. Nicole Fearnbach, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 10, 2018
• Study Start: July 2, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 17, 2020
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)