Study Results
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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COMPLETED
NA
19 participants
INTERVENTIONAL
2018-09-01
2019-08-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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 interventions assigned to this group
Measurement session Pre/Post Intervention
Questionnaires completed, blood draws, and fixed and ad lib meals completed to measure appetite and hormones. DXA completed.
No interventions assigned to this group
Home Assessments Pre/Post intervention
24-hour dietary recalls. Physical activity measured by monitors (Actigraph, ActivPAL).
No interventions assigned to this group
Physical Activity Session Pre/Post intervention
DXA, and Fitness testing to measure VO2submax and VO2max. Cognitive assessments will be administered.
No interventions assigned to this group
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.
No interventions assigned to this group
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).
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
17 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Robin Shook
Research Faculty PhD
Principal Investigators
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Robin Shook, PhD
Role: PRINCIPAL_INVESTIGATOR
Research Faculty PhD
Locations
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Children's Mercy Kansas City
Kansas City, Missouri, United States
Countries
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Other Identifiers
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00000096
Identifier Type: -
Identifier Source: org_study_id
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