Exercise, Brain Activity, and Weight Maintenance

Effects of Exercise Training on Brain Activity and Its Relation to Weight Maintenance and Appetite Regulation

This study aims to explore how HIIT influences brain function, neural and molecular pathways related to weight control, setting the stage for future obesity intervention research.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Weight Gain; Bariatric Surgery Candidate; Appetitive Behavior
• Intervention / Treatment: Other: Exercise

Detailed Description

This study will include adults aged 18-70 years with a BMI >19 kg/m², both with and without prior bariatric surgery. Those with bariatric surgery must have experienced clinically significant weight regain (>10% of maximum weight lost) within 1 to 5 years post-surgery.

Participants will complete three initial clinical visits before beginning a 12-week high-intensity interval training (HIIT) program, followed by three post-training clinical visits. During visit 1, participants will undergo anthropometric assessments, baseline blood draw, oral glucose tolerance test, psychometric evaluations, and complete an MRI safety screening. At visit 2, participants will complete a resting metabolic rate assessment and a VO₂peak test. During visit 3, participants will have another baseline blood draw and undergo a functional MRI (fMRI).

The HIIT program will consist of four weekly 28-minute sessions conducted at the Joslin Diabetes and at home. Each exercise session will include a 3-minute warm-up, six rounds of 40 seconds high-intensity followed by 3 minutes of moderate intensity, and will conclude with a 3-minute cool-down.

After completing the 12-week program, participants will return for clinical visits 4-6, repeating all baseline assessments.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Vamvini, MD; Phone Number: 617-309-2400; Email: Maria.Vamvini@joslin.harvard.edu
• Study Contact Backup: Name: Laura Simpson, MS; Phone Number: 617-735-3924; Email: laura.simpson@joslin.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Joslin Diabetes Center
      • Contact: Simpson; Phone Number: 617-735-3924; Email: laura.simpson@joslin.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-70 years
• Body mass index (BMI) >19 kg/m2 and body weight< 250kg
• Participants must have experienced a clinically significant weight regain, defined as over 10% of their maximum weight lost, within 1 to 5 years following their bariatric surgery. They will be asked to self-report their weight loss history. Participants must also provide the operative report from their bariatric surgery for reference.
• In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
• Willing to adhere to the protocol requirements for the duration of the study

Exclusion Criteria:

• Type 1 diabetes mellitus
• Peripheral neuropathy with insensate feet
• Recent blood donation within the last 2 months
• Use of beta-blockers
• Current pregnancy or breastfeeding
• Active Heart or lung disease
• Severe hypertension (systolic >160 mmHg or diastolic >90 mmHg)
• Inability to exercise for any reason
• Any known contraindication to exercise testing based on current ACSM guidelines
• MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
• Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
• Presence of another neurologic disorder, which could impact findings (e.g. multiple sclerosis)
• History of cardiovascular disease, stroke, congestive heart failure
• Active hematological, renal, pulmonary or hepatic disorders
• Active treatment for cancer
• A history of active alcohol or substance abuse
• Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol
• History of claustrophobia and inability to tolerate an MRI
• Body weight >250kgr and largest body diameter of 70cm as there is a certain weight and diameter limit of the MRI scanner
• Unwilling or unable to return for study visits, undergo neuropsychological testing and MRI imaging
• Left-handedness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Exercise Training; Subjects will complete a supervised high-intensity interval training program for 12 weeks, including four weekly training sessions. The training session will include a 3 minute warm-up followed by six 40 second bouts of high intensity (85-95% of VO2peak) with 3 minutes moderate intensity (45-55% of VO2peak) between each bout of high intensity, concluding with a 3 minute cool-down. Each participant's target heart rate will be specific to them, calculated from the exercise test completed during Visit 1.

Other: Exercise; High Intensity Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in connectivity between brain areas following exercise training by using resting state functional MRI.	Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in appetitive behavior.	Subjects will be evaluated with Three Factor Eating Questionnaire (TFEQ).	Evaluation of changes in hunger before and after 12 weeks of exercise training.
Changes in mood.	Subjects will be evaluated with Beck Depression Inventory II (BDI-II) to assess for depressive symptoms.	Evaluation of changes in mood before and after 12 weeks of exercise training.
Degree of changes in miRNA profiling of circulating exosomes in blood samples.	Changes in circulating exosome miRNAs will be measured using next-generation sequencing (NGS) and reported as normalized counts or fold changes relative to baseline.	Evaluation of changes in miRNA before and after 12 weeks of exercise training.
Changes in cognitive function.	Evaluation using mini cognitive test.	Changes in cognition function before and after 12 weeks of HIIT.

Collaborators and Investigators

• Sponsor: Joslin Diabetes Center
• Collaborators: Nutrition Obesity Research Center
• Investigators: Principal Investigator: Maria Vamvini, MD, Joslin Diabetes Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Behavior, Animal; Obesity; Weight Gain; Appetitive Behavior; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 00000256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No