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Brain, Appetite, Teens, and Exercise (BATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783390
Recruitment Status : Completed
First Posted : December 21, 2018
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
University of Kansas Medical Center
Information provided by (Responsible Party):
Robin Shook, Children's Mercy Hospital Kansas City

Study Description
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Brief Summary:
The long-term goal is to develop effective, evidence-based lifestyle interventions to prevent and treat childhood obesity and related co-morbidities. The short-term goal, and the purpose of this application, is to quantify appetite and neural mechanisms of food reward in overweight/obese (OW/OB) sedentary youth and to quantify changes following the implementation of a physical activity intervention. The central hypothesis is that appetite becomes dysregulated at low levels of physical activity via neural reward pathways, and appetite control will improve following a long-term exercise intervention. The investigators consider this project a pilot study designed to generate data to be used for future external funding opportunities, demonstrate collaboration between researchers, and test the feasibility of the protocols.

Condition or disease Intervention/treatment Phase
Energy Balance Appetitive Behavior Obesity Behavioral: Exercise Intervention Behavioral: Newsletter Not Applicable

Detailed Description:

Specific Aim 1: To identify associations between neural, psychological, and hormonal appetite control pathways using subjective and objective measures of appetite and neurocognitive assessments of reward pre-intervention.

Hypothesis 1: There will be significant cross-modulation of appetite across neural (brain activation), psychological (subjective hunger), and hormonal pathways (satiety biomarkers), though the temporal relationship between each in response to feeding is unknown.

Specific Aim 2: To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).

Hypothesis 2a: Those exposed to the exercise intervention will have greater improvements (compared to control group) in appetite (subjective self-reported hunger and palatability responses, and, objectively, satiety and appetite hormones glucose, insulin, ghrelin, and leptin, and calories consumed during ad libitum meal).

Hypothesis 2B. Compared to pre-intervention, OB/OW youth in the exercise group will show decreased reward activation in regions of the brain when making decisions about appetizing foods compared to post-intervention when hungry and when fed. In self-control regions, compared to pre-intervention, the investigators will observe increased activity in both hungry and fed conditions.

At the end of the proposed study, it is the expectation that the investigators will have collected important preliminary data regarding how long-term structured exercise acts upon appetite and neural mechanisms related to food reward in adolescents. Findings are key not only to interventions targeting OW/OB youth, but also to public policy and health recommendations for the importance of physical activity in children.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Brain, Activity, Teens, and Exercise (BATE)
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : August 10, 2019
Actual Study Completion Date : August 10, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Orientation
Informed consent, height, weight, and blood pressure measurement. A link to an online survey the participant and their parent can fill out at home about the participant's medical history will be given.
No Intervention: Measurement session Pre/Post Intervention
Questionnaires completed, blood draws, and fixed and ad lib meals completed to measure appetite and hormones. DXA completed.
No Intervention: Home Assessments Pre/Post intervention
24-hour dietary recalls. Physical activity measured by monitors (Actigraph, ActivPAL).
No Intervention: Physical Activity Session Pre/Post intervention
DXA, and Fitness testing to measure VO2submax and VO2max. Cognitive assessments will be administered.
No Intervention: fMRI Session Pre/Post intervention
The participant will have an fMRI completed and answer questions related to 60 food and activity images while in and out of the fMRI machine.
Experimental: Exercise Intervention/Newsletter
After completion of the initial fMRI session the participant will be randomly assigned to intervention for 3 months and then complete another round of assessments described as above (except for the orientation session).
 Behavioral: Exercise Intervention
Youth randomized to the active condition will participate in an organized exercise program. During the exercise program, adolescents will participate in a supervised structured exercise (treadmill walking/cycling on stationary bike) on 3 days equivalent to approximately 180 min/week of moderate-intensity exercise. The rationale for this dose of structured exercise is based on national (ADA) and international physical activity recommendations for youth of 60 minutes/day.

Behavioral: Newsletter
Families will receive a monthly newsletter with "parenting tips, sample praise statements, and child-appropriate activities and recipes" identical to what has been used in the work of leaders in the field of pediatric obesity. Previous research suggests that newsletter/mail interventions are well received by participants and are frequently included in federally funded health intervention studies.


Outcome Measures
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Primary Outcome Measures :
  1. Assess the effectiveness of a physical activity intervention on eating behavior- subjective responses [ Time Frame: 12 monthts ]

    To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).

    Those exposed to the exercise intervention will have greater improvements (compared to control group) in appetite (subjective self-reported hunger responses).



Secondary Outcome Measures :
  1. Assess changes in structural and functional MRI in response to an exercise intervention- prefrontal and hippocampal volume [ Time Frame: 12 months ]

    Assess changes in structural and functional MRI pre- to post- intervention in sedentary youth at risk for type 2 diabetes.

    Youth randomized to the exercise intervention will exhibit increases in prefrontal and hippocampal volume compared to controls.


  2. Assess changes in structural and functional MRI in response to an exercise intervention- reward and control [ Time Frame: 12 months ]

    Assess changes in structural and functional MRI pre- to post- intervention in sedentary youth at risk for type 2 diabetes.

    Compared to pre-intervention, youth in the exercise group will show de-creased activation in reward regions (orbitofrontal cortex, ventral striatum) when making food/activity choices; increased activation in control regions (dorsolateral PFC, inferior frontal gyrus) during food/activity choices.


  3. Assess the effectiveness of a physical activity intervention on eating behavior- subjective responses [ Time Frame: 12 monthts ]

    To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).

    Those exposed to the exercise intervention will have greater improvements (compared to control group) in appetite (subjective self-reported hunger responses).


  4. Assess the effectiveness of a physical activity intervention on eating behavior- biological responses [ Time Frame: 12 monthts ]

    To assess the effectiveness of a physical activity intervention on eating behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).

    Those exposed to the exercise intervention will have greater improvements (compared to control group) in appetite hormones ghrelin, and leptin.



Eligibility Criteria
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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Overweight/obese (BMI ≥85th to <99th percentile for age and sex)
  • Weight stable
  • Ages 14-17
  • No meds that may alter metabolism
  • Sedentary (<20 min/day exercise)

  • At risk for T2D, according to American Diabetes Association (ADA) criteria:

    • family history of T2D in first- or second- degree relative
    • Race/ethnicity (Native American, African American, Latino, Asian American, Pacific Islander)
    • Signs of insulin resistance
    • Maternal history of diabetes for gestational diabetes during child's gestation
  • Willing to participate in an exercise program
  • Willing to provide permission/assent

Exclusion Criteria:

  • BMI <85th percentile for age and sex
  • Weight not stable
  • Age <14 or >17
  • On meds that may alter metabolism
  • Active (>20 min/day exercise)
  • Not at risk for T2D, according to American Diabetes Association (ADA) criteria (see above)
  • Not willing to participate in an exercise program
  • Not willing to provide permission/assent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783390


Locations
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United States, Missouri
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64114
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
University of Kansas Medical Center
Investigators
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Principal Investigator: Robin Shook, PhD Research Faculty PhD
More Information
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Responsible Party: Robin Shook, Research Faculty PhD, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03783390    
Other Study ID Numbers: 00000096
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be kept private.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No