High-intensity interval exercise to support brain activity and weight maintenance
Effects of Exercise Training on Brain Activity and Its Relation to Weight Maintenance and Appetite Regulation
This trial will test whether a 12-week high-intensity interval training (HIIT) program changes brain activity and helps with weight maintenance in adults 18–70, including people who regained weight after bariatric surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Joslin Diabetes Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06511310 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–70 with BMI >19 kg/m², including people with prior bariatric surgery who have regained >10% of their maximum weight loss within 1–5 years, will complete three baseline visits with blood tests, metabolic and fitness testing, psychometric questionnaires, and an fMRI. Participants then follow a 12-week HIIT program with four 28-minute sessions per week performed both at the Joslin Diabetes Center and at home. After training, participants repeat the same clinical, metabolic, and imaging assessments to compare before-and-after changes in brain function, metabolic markers, and fitness. The protocol combines supervised and home-based exercise sessions and multimodal outcome measurements to link physiological and neural changes with weight-control behaviors.
Who should consider this trial
Good fit: Adults 18–70 with BMI >19 kg/m² who are in generally good health and willing to complete baseline testing, a 12-week HIIT program, and follow-up visits — including people who had bariatric surgery and experienced >10% weight regain 1–5 years after their operation.
Not a fit: People with contraindications to high-intensity exercise (for example active heart conditions, use of beta-blockers, type 1 diabetes, peripheral neuropathy with insensate feet, current pregnancy or breastfeeding) are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, the program could help people improve fitness and brain pathways involved in appetite and make it easier to maintain weight after weight loss or bariatric surgery.
How similar studies have performed: Previous HIIT studies have reliably improved cardiovascular fitness and some metabolic measures, but using HIIT to change brain pathways tied to weight maintenance after bariatric surgery is relatively novel and less established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Joslin Diabetes Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Maria Vamvini, MD — Joslin Diabetes Center
- Study coordinator: Maria Vamvini, MD
- Email: Maria.Vamvini@joslin.harvard.edu
- Phone: 617-309-2400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.