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

NCT ID: NCT03157063

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-11-19

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Physical Activity Sedentary Lifestyle Metabolism Energy Balance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Data Collection Procedures

Intervention Type 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)

Inactive, overweight/obese

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

Data Collection Procedures

Intervention Type 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

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

Data Collection Procedures

Intervention Type 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, overweight/obese

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

Data Collection Procedures

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robin Shook, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Kansas City

Locations

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Children's Mercy Kansas City

Kansas City, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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16120865

Identifier Type: -

Identifier Source: org_study_id

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