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

NCT03611296 | Completed

• 2 other identifiers: 2017-0095T32DK064584-15
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Baseline inhibitory control

  Year 0

• Change in inhibitory control over 2 years

  Year 0 and Year 2

• Baseline Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2)

  Year 0

• Change in Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) over 2 years

  Year 0 and Year 2

• Baseline appetite-related Visual Analog Scales (VAS)

  Year 0

Other Outcomes (4)

• Baseline body composition

  Year 0

• Change in body composition over 2 years

  Year 0 and Year 2

• Baseline activity patterns

  Year 0

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Eligible for the TIGER Kids primary study
• BMI \>/= 85th percentile
• Height \>/= 4 feet 6 inches
• Weight \< 350 pounds

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

• 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.

  PMID: 32335525 BACKGROUND

• 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.

  PMID: 35011098 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Per the TIGER Kids primary study protocol, an aliquot of sample will be stored in case further tests are needed and if further consent is obtained from the subject. However, no additional samples are retained for the ancillary study.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• S. Nicole Fearnbach, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Research

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 2, 2018
• Study Start: June 6, 2017
• Primary Completion: August 18, 2020
• Study Completion: August 18, 2020
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)