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Shape Up Kids Fitness Ancillary

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ClinicalTrials.gov Identifier: NCT03624582
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 27, 2019
Sponsor:
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

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.


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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2020



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.



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624582


Contacts
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Contact: S. Nicole Fearnbach, PhD 225-763-2612 Nicole.Fearnbach@pbrc.edu
Contact: Jessica St. Romain 225-763-2921 Jessica.Stromain@pbrc.edu

Locations
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United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: S. Nicole Fearnbach    225-763-2612    Nicole.Fearnbach@pbrc.edu   
Contact: Jessica St. Romain    225-763-2921    Jessica.Stromain@pbrc.edu   
Principal Investigator: S. Nicole Fearnbach, PhD         
Sub-Investigator: Corby K. Martin, PhD         
Sub-Investigator: Amanda E. Staiano, PhD         
Sub-Investigator: Robert L. Newton, PhD         
Sub-Investigator: Steven B. Heymsfield, MD         
Sub-Investigator: Daniel S. Hsia, MD         
Sub-Investigator: Owen T. Carmichael, PhD         
Sub-Investigator: Neil M. Johannsen, PhD         
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
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Principal Investigator: S. Nicole Fearnbach, PhD Pennington Biomedical Research Center

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Responsible Party: S. Nicole Fearnbach, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03624582     History of Changes
Other Study ID Numbers: 2018-028
P30DK072476 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms