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Completed

NCT Number: NCT03611296

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.

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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:

  • Ad libitum post-exercise food intake
  • Cognitive factors, including inhibitory control, food wanting, and motivation for food
  • Exercise-related factors, including cardiorespiratory fitness, substrate utilization (carbohydrate versus fat), and perceived exertion
  • Habitual physical and sedentary activity
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2018
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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