Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611296
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.)
First Posted : August 2, 2018
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
S. Nicole Fearnbach, Pennington Biomedical Research Center

Brief 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. The primary study also collects data on habitual physical and sedentary activity, body weight and body composition, and cardiometabolic health markers.

Condition or disease
Childhood Obesity

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020



Primary Outcome Measures :
  1. Baseline cardiorespiratory fitness [ Time Frame: Year 0 ]
    Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.

  2. Change in cardiorespiratory fitness over 2 years [ Time Frame: Year 0 and Year 2 ]
    Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.

  3. Baseline energy intake [ Time Frame: Year 0 ]
    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.

  4. Change in energy intake over 2 years [ Time Frame: Year 0 and Year 2 ]
    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.


Secondary Outcome Measures :
  1. Baseline inhibitory control [ Time Frame: Year 0 ]
    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).

  2. Change in inhibitory control over 2 years [ Time Frame: Year 0 and Year 2 ]
    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).

  3. Baseline Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) [ Time Frame: Year 0 ]
    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.

  4. Change in Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) over 2 years [ Time Frame: Year 0 and Year 2 ]
    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.

  5. Baseline appetite-related Visual Analog Scales (VAS) [ Time Frame: Year 0 ]
    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.

  6. Change in appetite-related Visual Analog Scales (VAS) over 2 years [ Time Frame: Year 0 and Year 2 ]
    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.


Other Outcome Measures:
  1. Baseline body composition [ Time Frame: Year 0 ]
    In the TIGER Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).

  2. Change in body composition over 2 years [ Time Frame: Year 0 and Year 2 ]
    In the TIGER Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).

  3. Baseline activity patterns [ Time Frame: Year 0 ]
    In the TIGER Kids primary study, activity is 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. Change in activity patterns over 2 years [ Time Frame: Year 0 and Year 2 ]
    In the TIGER Kids primary study, activity is 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.


Biospecimen Retention:   Samples Without DNA
Per the TIGER Kids primary study protocol, an aliquot of sample will be stored in case further tests are needed and if further consent is obtained from the subject. However, no additional samples are retained for the ancillary study.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

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): NCT03611296


Locations
Layout table for location information
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: S. Nicole Fearnbach, PhD Pennington Biomedical Research Center
Layout table for additonal information
Responsible Party: S. Nicole Fearnbach, Assistant Professor - Research, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03611296    
Other Study ID Numbers: 2017-009
5T32DK064584-15 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Inhibitory control
Motivation
Food intake
Body composition
Additional relevant MeSH terms:
Layout table for MeSH terms
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms