Brain, Appetite, Teens, and Exercise
BATE
Brain, Activity, Teens, and Exercise (BATE)
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedFirst Posted
Study publicly available on registry
December 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2019
CompletedMay 14, 2020
May 1, 2020
11 months
July 17, 2018
May 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Assess the effectiveness of a physical activity intervention on eating behavior- subjective responses
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).
12 monthts
Secondary Outcomes (4)
Assess changes in structural and functional MRI in response to an exercise intervention- prefrontal and hippocampal volume
12 months
Assess changes in structural and functional MRI in response to an exercise intervention- reward and control
12 months
Assess the effectiveness of a physical activity intervention on eating behavior- subjective responses
12 monthts
Assess the effectiveness of a physical activity intervention on eating behavior- biological responses
12 monthts
Study Arms (6)
Orientation
NO INTERVENTIONInformed 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.
Measurement session Pre/Post Intervention
NO INTERVENTIONQuestionnaires completed, blood draws, and fixed and ad lib meals completed to measure appetite and hormones. DXA completed.
Home Assessments Pre/Post intervention
NO INTERVENTION24-hour dietary recalls. Physical activity measured by monitors (Actigraph, ActivPAL).
Physical Activity Session Pre/Post intervention
NO INTERVENTIONDXA, and Fitness testing to measure VO2submax and VO2max. Cognitive assessments will be administered.
fMRI Session Pre/Post intervention
NO INTERVENTIONThe participant will have an fMRI completed and answer questions related to 60 food and activity images while in and out of the fMRI machine.
Exercise Intervention/Newsletter
EXPERIMENTALAfter 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).
Interventions
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Mercy Kansas City
Kansas City, Missouri, 64114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robin Shook, PhD
Research Faculty PhD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Faculty PhD
Study Record Dates
First Submitted
July 17, 2018
First Posted
December 21, 2018
Study Start
September 1, 2018
Primary Completion
August 10, 2019
Study Completion
August 10, 2019
Last Updated
May 14, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
Data will be kept private.