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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03611296
Enrollment
30
Registered
2018-08-02
Start date
2017-06-06
Completion date
2020-08-18
Last updated
2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Keywords

Cardiorespiratory fitness, Inhibitory control, Motivation, Food intake, Body composition

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.

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in cardiorespiratory fitness over 2 yearsYear 0 and Year 2Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
Baseline cardiorespiratory fitnessYear 0Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
Change in energy intake over 2 yearsYear 0 and Year 2Ad 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.
Baseline energy intakeYear 0Ad 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

MeasureTime frameDescription
Baseline appetite-related Visual Analog Scales (VAS)Year 0The 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.
Change in appetite-related Visual Analog Scales (VAS) over 2 yearsYear 0 and Year 2The 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.
Change in Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) over 2 yearsYear 0 and Year 2The 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.
Baseline inhibitory controlYear 0Inhibitory 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).
Change in inhibitory control over 2 yearsYear 0 and Year 2Inhibitory 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).
Baseline Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2)Year 0The 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.

Other

MeasureTime frameDescription
Baseline body compositionYear 0In the TIGER Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).
Change in activity patterns over 2 yearsYear 0 and Year 2In 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.
Baseline activity patternsYear 0In 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.
Change in body composition over 2 yearsYear 0 and Year 2In the TIGER Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026