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NCT Number: NCT03624582

Shape Up Kids Fitness 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.

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Key information

Conditions

Childhood Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Sedentary Behavior Signs and Symptoms

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Louisiana State University, Baton Rouge
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Leeds

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 10, 2018
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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