Energy BalanceBATENCT03783390
Brain, Appetite, Teens, and Exercise
A study testing Exercise Intervention and Newsletter in people with Energy Balance and Appetitive Behavior, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Energy Balance, Appetitive Behavior, Obesity
- What is being tested?
- Exercise Intervention and Newsletter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 10 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64114
About this study
Official title: Brain, Activity, Teens, and Exercise (BATE)
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.
Read the 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.
- Conditions
- Energy Balance, Appetitive Behavior, Obesity
- Being tested
- Exercise Intervention, Newsletter
- Medical subject headings
- Appetitive Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
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.
NewsletterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Orientation | No intervention | 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. |
| Measurement session Pre/Post Intervention | No intervention | Questionnaires completed, blood draws, and fixed and ad lib meals completed to measure appetite and hormones. DXA completed. |
| Home Assessments Pre/Post intervention | No intervention | 24-hour dietary recalls. Physical activity measured by monitors (Actigraph, ActivPAL). |
| Physical Activity Session Pre/Post intervention | No intervention | DXA, and Fitness testing to measure VO2submax and VO2max. Cognitive assessments will be administered. |
| fMRI Session Pre/Post intervention | No 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. |
| Exercise Intervention/Newsletter | Experimental | 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). Receives: Behavioral: Exercise Intervention; Behavioral: Newsletter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 monthts
Secondary outcomes (4)
Assess changes in structural and functional MRI in response to an exercise intervention- prefrontal and hippocampal volume
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.
Measured: 12 months
Assess changes in structural and functional MRI in response to an exercise intervention- reward and control
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.
Measured: 12 months
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).
Measured: 12 monthts
Assess the effectiveness of a physical activity intervention on eating behavior- biological 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 hormones ghrelin, and leptin.
Measured: 12 monthts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start1 Sep 2018
- Primary completion10 Aug 2019
- Study completion10 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Principal investigator, Robin Shook, Children's Mercy Hospital Kansas City
- Investigators
- Robin Shook, PhD, Principal investigator, Research Faculty PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783390
- Sponsor's protocol ID
- 00000096
- Acronym
- BATE
- Status last verified
- May 2020
- First submitted
- 17 Jul 2018
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be kept private.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain, Activity, Teens, and Exercise (BATE)
- ClinicalTrials.gov ID
- NCT03783390
- Acronym / sponsor ID
- BATE / 00000096
- Conditions
- Energy Balance, Appetitive Behavior, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- 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).
| Arm | Type | Receives |
|---|---|---|
| Orientation | No intervention | –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. |
| Measurement session Pre/Post Intervention | No intervention | –Questionnaires completed, blood draws, and fixed and ad lib meals completed to measure appetite and hormones. DXA completed. |
| Home Assessments Pre/Post intervention | No intervention | –24-hour dietary recalls. Physical activity measured by monitors (Actigraph, ActivPAL). |
| Physical Activity Session Pre/Post intervention | No intervention | –DXA, and Fitness testing to measure VO2submax and VO2max. Cognitive assessments will be administered. |
| fMRI Session Pre/Post intervention | No 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. |
| Exercise Intervention/Newsletter | Experimental | Behavioral: Exercise Intervention, Behavioral: NewsletterAfter 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). |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionYouth 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. | Behavioural | Exercise Intervention/Newsletter |
| NewsletterFamilies 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. | Behavioural | Exercise Intervention/Newsletter |
Primary outcome
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 secondary outcomes
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 in response to an exercise intervention- reward and control
Time frame: 12 months
Assess the effectiveness of a physical activity intervention on eating behavior- subjective responses
Time frame: 12 monthts
Assess the effectiveness of a physical activity intervention on eating behavior- biological responses
Time frame: 12 monthts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: No. Data will be kept private.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Shook, PhD principal investigator
Research Faculty PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention and Newsletter in people with Energy Balance and Appetitive Behavior, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effectiveness of a physical activity intervention on eating behavior- subjective responses (time frame: 12 monthts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020; AzTrials last refreshed its copy on 29 Oct 2026.