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Childhood ObesityNCT03624582

Shape Up Kids Fitness Ancillary

An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Obesity
How many people
60 participants
Where
1 siteUnited States
Study dates
2 Jul 2018to 17 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
Cardiorespiratory fitness, Sedentary behavior, Physical activity, Decision-making, Cardiometabolic risk factors
Medical subject headings
Pediatric Obesity, Sedentary Behavior, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 0 / Primary Study Visit

  2. 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.

    Measured: 8-21 days after Primary Study Visit

  3. 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.

    Measured: 7 days between visits

  4. 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.

    Measured: 8-21 days after Primary Study Visit

Secondary outcomes (10)

  1. Cardiorespiratory fitness

    Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.

    Measured: 8-21 days after Primary Study Visit

  2. Body composition 1

    In the Shape Up Kids primary study, body composition is measured using bioelectrical impedance analysis (BIA).

    Measured: Day 0 / Primary Study Visit

  3. Body composition 2

    In the Shape Up Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).

    Measured: Day 0 / Primary Study Visit

  4. Body composition 3

    In the Shape Up Kids primary study, body composition is measured using whole-body magnetic resonance imaging (MRI).

    Measured: Day 0 / Primary Study Visit

  5. Physical strength

    In the Shape Up Kids primary study, physical strength is assessed with dynamometers.

    Measured: Day 0 / Primary Study Visit

  6. Resting blood pressure

    In the Shape Up Kids primary study, blood pressure is assessed after 5 minutes of rest.

    Measured: Day 0 / Primary Study Visit

  7. Resting heart rate

    In the Shape Up Kids primary study, heart rate is assessed after 5 minutes of rest.

    Measured: Day 0 / Primary Study Visit

  8. Cardiometabolic disease biomarkers

    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.

    Measured: Day 0 / Primary Study Visit

  9. Time 1 activity liking and wanting Visual Analog Scale (VAS) scores

    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"

    Measured: Day 0 / Primary Study Visit

  10. Time 2 activity liking and wanting VAS scores

    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"

    Measured: 8-21 days after Primary Study Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start2 Jul 2018
  3. Primary completion30 Dec 2019
  4. Study completion17 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03624582
Sponsor's protocol ID
2018-028
Other IDs
P30DK072476
Status last verified
Jun 2022
First submitted
25 Jul 2018
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32831103

Questions about this trial

What is this clinical trial studying?

An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time 1 APA bias scores (time frame: Day 0 / Primary Study Visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03624582, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.

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