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Activity, Adiposity, and Appetite in Adolescents 2 (AAAA2)

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ClinicalTrials.gov Identifier: NCT04028921
Recruitment Status : Withdrawn (Study Withdrawn)
First Posted : July 23, 2019
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Brief Summary:
Our goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. We will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight and physical activity using across-sectional study design.

Condition or disease Intervention/treatment
Obesity Metabolic Disease Insulin Sensitivity Other: No intervention

Detailed Description:
Childhood obesity is the most serious public health problem of the 21st century, given the prevalence, global reach, and widespread health, economic, and social consequences. While weight gain at the most basic level is due to a chronic energy surplus, there are a host of influences that act on the energy balance system that remain largely unknown. Thus, there is a critical need to identify previously unexamined factors that may influence the energy balance system in order to develop effective interventions for prevention and treatment. Our long-term goal is to quantify the dynamic relationships between various physiological and psychological components of the energy balance system. Our short-term goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. The status quo as it relates to appetite control is that body weight status and related peripheral signals are a key regulator of energy intake. In contrast to body weight playing a primary role in energy regulation, our working hypothesis is that high levels of regular moderate-to-vigorous physical activity (MVPA) result in a metabolic phenotype consisting of enhanced metabolic function and proper regulation of appetite, which prevents the development of obesity. We have reported that adults with low levels of MVPA have dysregulated appetite control, evidenced by higher levels of energy intake and elevated levels of dietary disinhibition. Additionally, we have observed that rats with low fitness possess dysregulated control of appetite and reduced hepatic fat oxidation compared to rats with high fitness. Based on these findings in adults and rodents, in addition to supportive work by others, we hypothesize that low levels of MVPA create a metabolic phenotype, leading to dysregulated appetite control which predisposes individuals to weight gain. To test this hypothesis we will perform two studies focused on the links between physical activity and appetite. For Study 1, we will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight (normal vs overweight/obese) and physical activity (sedentary vs. active) using a 2 x 2 cross-sectional study design (N=40). For Study 2, we will examine the influence of MVPA on the same outcomes by randomly assigning sedentary overweight/obese adolescents (N=44) to either a structured-exercise group or no treatment control for three months. The specific aims of the proposed studies are: 1) To examine the association between physical activity and appetite control in adolescents, with metabolic function serving as a mediator; and, 2) To test if increased physical activity through an exercise intervention influences metabolic function and appetite control. At the completion of the proposed studies, it is our expectation that we will have described the independent effects of physical activity and body weight on energy metabolism and appetite in adolescents. This study will have a significant positive impact on the understanding of energy balance in adolescents, and will inform public health interventions that specifically target mechanisms associated with weight gain in youth.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Activity, Adiposity, and Appetite in Adolescents 2
Actual Study Start Date : May 7, 2019
Actual Primary Completion Date : February 14, 2020
Actual Study Completion Date : February 14, 2020

Group/Cohort Intervention/treatment
Normal weight, active
Male and female adolescents (age 14-17 years), BMI percentile >=5th to <75th for age/sex, >=60 min/day of moderate/vigorous physical activity.
Other: No intervention
This is a cross-sectional study; no intervention

Normal weight, sedentary
Male and female adolescents (age 14-17 years), BMI percentile >=5th to <75th for age/sex, <60 min/day of moderate/vigorous physical activity.
Other: No intervention
This is a cross-sectional study; no intervention

Overweight/obese, active
Male and female adolescents (age 14-17 years), BMI percentile >=85th to <99th for age/sex, >=60 min/day of moderate/vigorous physical activity.
Other: No intervention
This is a cross-sectional study; no intervention

Overweight/obese, sedentary
Male and female adolescents (age 14-17 years), BMI percentile >=85th to <99th for age/sex, <60 min/day of moderate/vigorous physical activity.
Other: No intervention
This is a cross-sectional study; no intervention




Primary Outcome Measures :
  1. Appetite- subjective [ Time Frame: We will calculate overall subjective appetite responses using area-under the curve analysis of hunger responses at seven timepoints: pre-meal, 15-min post, 45-min post, 60-min post, 90-min post, 120-min post, 150-min post, and 180-min post. ]
    We will measure subjective appetite ratings using visual analog scales related to hunger following a fixed-calorie meal.

  2. Appetite- objective [ Time Frame: We will calculate overall objective appetite responses using area-under the curve analysis of plasma ghrelin at seven timepoints: pre-meal, 15-min post, 45-min post, 60-min post, 90-min post, 120-min post, 150-min post, and 180-min post. ]
    We will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal.



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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy males and females.
Criteria

Inclusion Criteria:

  • Tanner Stage III-V
  • Weight-stable (± 10%) within the previous 3 months
  • Non-smoking
  • Not currently involved in any other research study

Exclusion Criteria:

  • Restrained eater (>13) on the restraint section of the three-factor eating questionnaire; Current/past diagnosis of an eating disorder
  • Past pregnancy
  • Self-reported medical conditions (diabetes, Crohn's disease, etc.) that may affect adherence to the protocol or exercising safely or alter metabolism
  • Medications known to affect exercise performance or metabolism (e.g. thyroid medication, beta-blockers, or stimulants)
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Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT04028921    
Other Study ID Numbers: STUDY00000725
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregated results will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Metabolic Diseases
Hyperinsulinism
Glucose Metabolism Disorders