Shape Up Kids Fitness Ancillary

June 15, 2022 updated by: S. Nicole Fearnbach, Pennington Biomedical Research Center

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 / Primary Study Visit
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.
8-21 days after Primary Study Visit
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.
7 days between visits
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.
8-21 days after Primary Study Visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8-21 days after Primary Study Visit
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).
Day 0 / Primary Study Visit
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).
Day 0 / Primary Study Visit
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).
Day 0 / Primary Study Visit
Physical strength
Time Frame: Day 0 / Primary Study Visit
In the Shape Up Kids primary study, physical strength is assessed with dynamometers.
Day 0 / Primary Study Visit
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.
Day 0 / Primary Study Visit
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.
Day 0 / Primary Study Visit
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.
Day 0 / Primary Study Visit
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"
Day 0 / Primary Study Visit
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"
8-21 days after Primary Study Visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8-21 days after Primary Study Visit
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.
8-21 days after Primary Study Visit
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.
8-21 days after Primary Study Visit
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.
8-21 days after Primary Study Visit
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.
8-21 days after Primary Study Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 17, 2020

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-028
  • P30DK072476 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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