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

Physical Activity Clinical Trial

— AAAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157063
• Other study ID #: 16120865
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: November 19, 2018

Study information

• Verified date: January 2019
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Energy Balance
• Metabolism
• Obesity
• Physical Activity
• Sedentary Lifestyle

Intervention

Diagnostic Test:
• Data Collection Procedures
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)

Locations

Country	Name	City	State
United States	Children's Mercy Kansas City	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The neurocognitive mechanisms of appetite control as assessed by functional MRI.	The investigators will measure neural activity in reward (limbic) and self-control (prefrontal) areas of the brain using functional MRI.	2 years
Primary	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	Physical activity levels, as measured by subjective appetite ratings and hormones related to appetite, independent of obesity status.	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.	2 years