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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline cardiorespiratory fitness	Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.	Year 0
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.	Year 0 and Year 2
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.	Year 0
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.	Year 0 and Year 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Year 0
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).	Year 0 and Year 2
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.	Year 0
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.	Year 0 and Year 2
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.	Year 0
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.	Year 0 and Year 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline body composition	In the TIGER Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).	Year 0
Change in body composition over 2 years	In the TIGER Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).	Year 0 and Year 2
Baseline activity patterns	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.	Year 0
Change in activity patterns over 2 years	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.	Year 0 and Year 2

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: S. Nicole Fearnbach, PhD, Pennington Biomedical Research Center

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): August 18, 2020
• Study Completion (Actual): August 18, 2020

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Motivation; Body composition; Cardiorespiratory fitness; Food intake; Inhibitory control
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 2017-009; 5T32DK064584-15 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No