Pilot Data Collection for Activity, Adiposity, and Appetite in Adolescents

NCT03157063 | Completed

• 1 other identifier: 16120865
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to quantify energy metabolism using indirect calorimetry at rest, in the presence of excess energy following a meal, and in response to the demand for energy during exercise. The investigators also will examine the individual and joint associations of activity and obesity status on neurocognitive domains of appetite control. Participants will include adolescent males and females (N=80) using a 2 x 2 cross-sectional study design, stratified by body weight (normal vs overweight/obese) and physical activity level (sedentary vs. active).

Conditions

Physical Activity; Sedentary Lifestyle; Metabolism; Energy Balance

Outcome Measures

Primary Outcomes (1)

• The independent effects of physical inactivity and obesity on metabolic responses (energy expenditure) at rest, after a meal, and during exercise using indirect calorimetry.

  The investigators will measure energy expenditure at rest (also called resting metabolic rate), following a fixed-calorie meal (also called thermic effect of feeding), and during submaximal walking on a treadmill, all using an indirect calorimeter.

  1 year

Secondary Outcomes (1)

• Physical activity levels, as measured by subjective appetite ratings and hormones related to appetite, independent of obesity status.

  2 years

Other Outcomes (1)

• The neurocognitive mechanisms of appetite control as assessed by functional MRI.

  2 years

Study Arms (4)

Inactive, normal weight

Less than 30 minutes per day of moderate to vigorous physical activity (MVPA), and body mass index percentile (BMI%) between 5th to 75th percentile.

Diagnostic Test: Data Collection Procedures

Inactive, overweight/obese

Less than 30 minutes per day MVPA, BMI% between 85th and 99th.

Diagnostic Test: Data Collection Procedures

Active, normal weight

More than 60 minutes per day MVPA, BMI% between 5th and 75th.

Diagnostic Test: Data Collection Procedures

Active, overweight/obese

More than 60 minutes per day MVPA, BMI% between 85th and 99th.

Diagnostic Test: Data Collection Procedures

Interventions

Data Collection Procedures DIAGNOSTIC_TEST

Orientation (Consent, Screening Questionnaires) Clinic Measurements Body composition, via dual energy X-ray absorptiometry (DXA) Resting metabolic rate (RMR), via indirect calorimetry; Metabolic responses to a meal, via thermic effect of feeding (TEF) Subjective aspects of eating behavior using the Three Factor Eating Questionnaire (TFEQ) and Control of Eating Questionnaire (CEQ) Appetite, via visual analogue scales (VAS) pre- and post a prepared fixed meal and hormones related to satiety and hunger (insulin, leptin, ghrelin, peptide YY, glucagon-like peptide-1) obtained during blood samples (BLOOD) from an indwelling catheter. Home assessments - Data collected at home during a 14 day window Fitness Test (VO2submax and VO2max) and DXA functional magnetic resonance imaging (fMRI)

Active, normal weight; Active, overweight/obese; Inactive, normal weight; Inactive, overweight/obese

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will include 60 adolescent males (aged 14-18 years, Tanner stages III- IV), equally enrolled based on physical activity and body weight status.

You may qualify if:

• Males (Tanner Stage III-IV), ages 14-18
• Weight stable (5% weight change) over the previous three months as assessed by self-report.
• BMI greater than 5th and less than 99th percentile
• Physically healthy for exercise as assessed by self report Physical Activity Readiness Questionnaire (PAR-Q) for children.
• For fMRI testing, all participants must be right handed and must have normal or corrected to normal vision (as they will be viewing pictures in the fMRI procedure).

You may not qualify if:

• History of restrained eating, eating disorders, bariatric surgery, or other significant medical diagnosis that could impact metabolism.
• Participants taking thyroid medications, beta blockers, or other stimulants (medications are known to affect physical activity level and metabolism).
• Due to fMRI procedure requirements, children with a history of Attention Deficit Hyperactivity Disorder (ADHD) or other diagnosed psychiatric issues will be excluded.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• University of Kansas Medical Center: collaborator

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

hormones related to satiety and hunger (insulin, leptin, ghrelin, peptide YY, glucagon-like peptide-1) obtained during blood samples (BLOOD) from an indwelling catheter.

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Robin Shook, PhD

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 17, 2017
• Study Start: January 1, 2017
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: April 26, 2021

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)