AzTrials
AzTrials

Childhood ObesityNCT03611296

Translational Investigation of Growth and Everyday Routines in Kids (TIGER 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
Search all trials

Trial summary

The purpose of this ancillary study is to examine cardiorespiratory fitness, cognitive factors related to appetite, and objectively-measured food intake in a subsample of children and adolescents with overweight to severe obesity enrolled in the TIGER Kids prospective cohort. Read more about this study

Who is it for?
Ages 10 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Obesity
How many people
30 participants
Where
1 siteUnited States
Study dates
6 Jun 2017to 18 Aug 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 10 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: This study will identify and recruit 30 participants from the TIGER Kids primary study sample of 340 participants. Ancillary participants will be between the ages of 10-16 years and above the 85th age- and sex-specific BMI percentile (i.e., overweight to severe obesity). We will have an even distribution of boys (n=15) and girls (n=15) and aim to have a representative distribution of race.

Who may be able to join

  • Eligible for the TIGER Kids primary study
  • BMI >/= 85th percentile
  • Height >/= 4 feet 6 inches
  • Weight < 350 pounds

Who cannot join

  • Anemia
  • 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

The purpose of this ancillary study is to examine cardiorespiratory fitness, cognitive factors related to appetite, and objectively-measured food intake in a subsample of children and adolescents with overweight to severe obesity enrolled in the TIGER Kids prospective cohort. The primary study also collects data on habitual physical and sedentary activity, body weight and body composition, and cardiometabolic health markers.

Read the detailed description

The investigators will enroll 30 boys and girls (50% female) between the ages of 10-16 years and above the 85th BMI percentile (i.e., overweight to severe obesity) in this pilot ancillary study. The objective is to examine interactions between the following energy-balance related factors:

  1. Ad libitum post-exercise food intake
  2. Cognitive factors, including inhibitory control, food wanting, and motivation for food
  3. Exercise-related factors, including cardiorespiratory fitness, substrate utilization (carbohydrate versus fat), and perceived exertion
  4. Habitual physical and sedentary activity
  5. Body composition and cardiometabolic health

The prospective, longitudinal nature of the study will allow the investigators to examine these variables cross-sectionally and quantify change over two years. Of particular interest is whether cognitive factors related to energy balance, including perceived exertion, inhibitory control, food wanting, and food motivation, vary across time or are relatively stable. Finally, the investigators will assess the ability of these factors to predict changes in body composition and cardiometabolic health over two years.

Keywords
Cardiorespiratory fitness, Inhibitory control, Motivation, Food intake, Body composition
Medical subject headings
Pediatric Obesity

What is being measured

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

  1. Baseline cardiorespiratory fitness

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

    Measured: Year 0

  2. Change in cardiorespiratory fitness over 2 years

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

    Measured: Year 0 and Year 2

  3. Baseline energy intake

    Ad libitum energy intake in kilocalories is measured using a in-laboratory dinner test-meal. Participants can eat as much or as little as they would like from the available food, which is provided in excess of energy needs.

    Measured: Year 0

  4. Change in energy intake over 2 years

    Ad libitum energy intake in kilocalories is measured using a in-laboratory dinner test-meal. Participants can eat as much or as little as they would like from the available food, which is provided in excess of energy needs.

    Measured: Year 0 and Year 2

Secondary outcomes (6)

  1. Baseline inhibitory control

    Inhibitory control is measured using a Go/No-go behavioral task administered on a computer. Errors, false alarms, and reaction times are collected for various conditions: baseline, food rewards (favorite snack and least favorite snack from a selected list of options) and neutral control (unrewarded).

    Measured: Year 0

  2. Change in inhibitory control over 2 years

    Inhibitory control is measured using a Go/No-go behavioral task administered on a computer. Errors, false alarms, and reaction times are collected for various conditions: baseline, food rewards (favorite snack and least favorite snack from a selected list of options) and neutral control (unrewarded).

    Measured: Year 0 and Year 2

  3. Baseline Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2)

    The Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) consists of three appetite-related subscales: Cognitive Restraint, Emotional Eating, and Uncontrolled Eating. Subscales are scored on a range from 0-100, with higher scores representing higher levels of that construct.

    Measured: Year 0

  4. Change in Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) over 2 years

    The Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) consists of three appetite-related subscales: Cognitive Restraint, Emotional Eating, and Uncontrolled Eating. Subscales are scored on a range from 0-100, with higher scores representing higher levels of that construct.

    Measured: Year 0 and Year 2

  5. Baseline appetite-related Visual Analog Scales (VAS)

    The following constructs are measured before and after the fitness test and before and after the dinner test-meal: Hunger, fullness, desire to eat, prospective food consumption, satisfaction, and wanting for specific foods (age-appropriate and commonly consumed foods for this population). VAS scores range from 0-100, with higher scores representing higher levels of that construct.

    Measured: Year 0

  6. Change in appetite-related Visual Analog Scales (VAS) over 2 years

    The following constructs are measured before and after the fitness test and before and after the dinner test-meal: Hunger, fullness, desire to eat, prospective food consumption, satisfaction, and wanting for specific foods (age-appropriate and commonly consumed foods for this population). VAS scores range from 0-100, with higher scores representing higher levels of that construct.

    Measured: Year 0 and Year 2

Timeline

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

  1. First posted2 Aug 2018
  2. Study start6 Jun 2017
  3. Primary completion18 Aug 2020
  4. Study completion18 Aug 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
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03611296
Sponsor's protocol ID
2017-009
Other IDs
5T32DK064584-15
Status last verified
Jun 2022
First submitted
2 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, Johannsen NM, Martin CK, Katzmarzyk PT, Beyl RA, Hsia DS, Carmichael OT, Staiano AE. A Pilot Study of Cardiorespiratory Fitness, Adiposity, and Cardiometabolic Health in Youth With Overweight and Obesity. Pediatr Exerc Sci. 2020 Apr 25;32(3):124-131. doi: 10.1123/pes.2019-0192.

    PubMed 32335525

  • Fearnbach N, Staiano AE, Johannsen NM, Hsia DS, Beyl RA, Carmichael OT, Martin CK. Predictors of Post-Exercise Energy Intake in Adolescents Ranging in Weight Status from Overweight to Severe Obesity. Nutrients. 2022 Jan 5;14(1):223. doi: 10.3390/nu14010223.

    PubMed 35011098

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 4 inclusion and 2 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?

Baseline cardiorespiratory fitness (time frame: Year 0). 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 NCT03611296, which also lists 2 linked publications.

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; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in