Shape Up Kids Fitness Ancillary

• ClinicalTrials.gov Identifier: NCT03624582
• Recruitment Status: Completed
• First Posted: August 10, 2018
• Last Update Posted: February 5, 2021
• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Louisiana State University, Baton Rouge; University of Leeds
• Information provided by (Responsible Party): S. Nicole Fearnbach, Pennington Biomedical Research Center

Study Description

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.

Condition or disease
Childhood Obesity

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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Validity and Reliability of the Activity Preference Assessment: A Shape Up Kids Ancillary
• Actual Study Start Date: July 2, 2018
• Actual Primary Completion Date: December 30, 2019
• Actual Study Completion Date: December 17, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Time 1 APA bias scores [ Time Frame: Day 0 / Primary Study Visit ]
   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.
2. Time 2 APA bias scores [ Time Frame: 8-21 days after Primary Study Visit ]
   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.
3. Habitual physical and sedentary activity [ Time Frame: 7 days between visits ]
   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.
4. Free-choice play period [ Time Frame: 8-21 days after Primary Study Visit ]
   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.

Secondary Outcome Measures :

1. Cardiorespiratory fitness [ Time Frame: 8-21 days after Primary Study Visit ]
   Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
2. Body composition 1 [ Time Frame: Day 0 / Primary Study Visit ]
   In the Shape Up Kids primary study, body composition is measured using bioelectrical impedance analysis (BIA).
3. 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).
4. 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).
5. Physical strength [ Time Frame: Day 0 / Primary Study Visit ]
   In the Shape Up Kids primary study, physical strength is assessed with dynamometers.
6. Resting blood pressure [ Time Frame: Day 0 / Primary Study Visit ]
   In the Shape Up Kids primary study, blood pressure is assessed after 5 minutes of rest.
7. Resting heart rate [ Time Frame: Day 0 / Primary Study Visit ]
   In the Shape Up Kids primary study, heart rate is assessed after 5 minutes of rest.
8. Cardiometabolic disease biomarkers [ Time Frame: Day 0 / Primary Study Visit ]
   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.
9. Time 1 activity liking and wanting Visual Analog Scale (VAS) scores [ Time Frame: Day 0 / Primary Study Visit ]
   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"
10. Time 2 activity liking and wanting VAS scores [ Time Frame: 8-21 days after Primary Study Visit ]
    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"

Other Outcome Measures:

1. International Sedentary Assessment Tool [ Time Frame: 8-21 days after Primary Study Visit ]
   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.
2. Mood and Feelings Questionnaire [ Time Frame: 8-21 days after Primary Study Visit ]
   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.
3. Physical Self Description Scale [ Time Frame: 8-21 days after Primary Study Visit ]
   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.
4. Body Esteem Scale [ Time Frame: 8-21 days after Primary Study Visit ]
   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.
5. Neighborhood and home environment survey [ Time Frame: 8-21 days after Primary Study Visit ]
   Parents will describe environmental factors through a neighborhood and home environment survey. Selected items from this survey will be used as covariates in analyses.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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)

Contacts and Locations

Locations

United States, Louisiana

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Pennington Biomedical Research Center

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Louisiana State University, Baton Rouge

University of Leeds

Investigators

• Principal Investigator: S. Nicole Fearnbach, PhD; Pennington Biomedical Research Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: S. Nicole Fearnbach, Principal Investigator, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT03624582
• Other Study ID Numbers: 2018-028; P30DK072476 ( U.S. NIH Grant/Contract )
• First Posted: August 10, 2018
• Last Update Posted: February 5, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by S. Nicole Fearnbach, Pennington Biomedical Research Center:

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

Additional relevant MeSH terms:

Pediatric Obesity; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight