Clinical trial NCT03611296: Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary
Official title: Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Keywords: Cardiorespiratory fitness
Inhibitory control
Motivation
Food intake
Body composition
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: Baseline cardiorespiratory fitness
timeFrame: Year 0
measure: Change in cardiorespiratory fitness over 2 years
timeFrame: Year 0 and Year 2
measure: Baseline energy intake
timeFrame: Year 0
measure: Change in energy intake over 2 years
timeFrame: Year 0 and Year 2
Secondary outcomes:
measure: Baseline inhibitory control
timeFrame: Year 0
measure: Change in inhibitory control over 2 years
timeFrame: Year 0 and Year 2
measure: Baseline Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2)
timeFrame: Year 0
measure: Change in Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) over 2 years
timeFrame: Year 0 and Year 2
measure: Baseline appetite-related Visual Analog Scales (VAS)
timeFrame: Year 0
measure: Change in appetite-related Visual Analog Scales (VAS) over 2 years
timeFrame: Year 0 and Year 2
Other outcomes:
measure: Baseline body composition
timeFrame: Year 0
measure: Change in body composition over 2 years
timeFrame: Year 0 and Year 2
measure: Baseline activity patterns
timeFrame: Year 0
measure: Change in activity patterns over 2 years
timeFrame: Year 0 and Year 2
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: S. Nicole Fearnbach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.