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

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611296
• Other study ID #: 2017-009
• Secondary ID: 5T32DK064584-15
• Status: Completed
• Start date: June 6, 2017
• Est. completion date: August 18, 2020

Study information

• Verified date: June 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 18, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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). pii: 223. doi: 10.3390/nu14010223. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline body composition	In the TIGER Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).	Year 0
Other	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
Other	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
Other	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
Primary	Baseline cardiorespiratory fitness	Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.	Year 0
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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