Brain, Appetite, Teens, and Exercise (BATE)

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Appetitive Behavior; Obesity; Energy Balance

Treatments: Behavioral: Exercise Intervention; Behavioral: Newsletter

Study type: Interventional

Funder types: Other

Identifiers

NCT03783390

00000096

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 14 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 6 patient groups

Orientation

No Intervention group

Description:

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 group

Description:

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 group

Description:

24-hour dietary recalls. Physical activity measured by monitors (Actigraph, ActivPAL).

Physical Activity Session Pre/Post intervention

No Intervention group

Description:

DXA, and Fitness testing to measure VO2submax and VO2max. Cognitive assessments will be administered.

fMRI Session Pre/Post intervention

No Intervention group

Description:

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 group

Description:

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).

Treatment:

Behavioral: Newsletter

Behavioral: Exercise Intervention