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Completed

NCT Number: NCT03157063

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

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).

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Key information

Age range

14 year–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

About this study

The investigators hypothesize that low levels of fitness and MVPA result in impaired metabolic function in adolescents. For this pilot study, the investigators will quantify variations in metabolic characteristics using a 2 x 2 cross-sectional study design, stratified by body weight (normal vs overweight/obese) and physical activity (sedentary vs. active). The goal is to identify metabolic factors that influence the energy balance system to directly inform interventions designed to prevent or reduce the prevalence of pediatric obesity.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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)

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.

    Time frame: 1 year

    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.

Secondary outcomes

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

    Time frame: 2 years

    The investigators will measure subjective appetite ratings related to hunger, fullness, etc. using visual analog scales and hormones related to appetite control following a fixed-calorie meal and buffet-style meal.

Other outcomes

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

    Time frame: 2 years

    The investigators will measure neural activity in reward (limbic) and self-control (prefrontal) areas of the brain using functional MRI.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • University of Kansas Medical Center

Registry information

Acronym: AAAA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 17, 2017
Registry last updated
Apr 26, 2021

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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