Exercise for Obesity

Overseen By Maria Vamvini, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Joslin Diabetes Center

Must not be taking: Beta-blockers

Disqualifiers: Type 1 diabetes, Heart disease, Hypertension, Neurologic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of high-intensity interval training (HIIT) on brain function and pathways that control weight. Participants will follow a structured 12-week exercise program with four intense workouts each week. It suits individuals who have regained more than 10% of weight lost after bariatric surgery. Participants should be generally healthy and able to adhere to the exercise plan. As an unphased trial, this study provides an opportunity to contribute to groundbreaking research on exercise and weight management.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use beta-blockers. It's best to discuss your medications with the study team.

What prior data suggests that this exercise protocol is safe?

Research shows that high-intensity interval training (HIIT) is generally safe and manageable for most people. Studies have found that HIIT can aid in weight loss and enhance heart health. Although it might not significantly alter body mass index (BMI), it can reduce body fat and boost fitness levels. Importantly, these studies reported no serious side effects, indicating that HIIT is a safe exercise option for most individuals, including those who are overweight. It is advisable to consult a healthcare provider before beginning any new exercise program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment because it uses high-intensity interval training (HIIT) to tackle obesity in a way that is different from traditional methods like dieting or weight-loss medications. Unlike standard treatments, which often focus on reducing calorie intake or altering metabolism through drugs, this approach emphasizes short bursts of high-intensity exercise followed by periods of moderate activity. This method can potentially increase cardiovascular fitness and accelerate fat loss more effectively than continuous moderate exercise, offering a promising alternative for individuals looking to manage obesity through physical activity.

What evidence suggests that exercise might be an effective treatment for obesity?

Research shows that High-Intensity Interval Training (HIIT), which participants in this trial will undergo, can aid in weight control and reduce body fat. Studies have found that HIIT improves heart and lung fitness and leads to noticeable fat loss. For example, one analysis reported that overweight and obese adults lost 1.7 kg of body fat. Another study found that HIIT surpassed moderate exercise for weight loss in obese adults over 12 weeks. HIIT also helps the body burn fat more efficiently while preserving muscle mass. These findings suggest that HIIT is a promising method for managing obesity. ^{3 6 7 8 9}

Who Is on the Research Team?

Maria Vamvini, MD

Principal Investigator

Joslin Diabetes Center

Are You a Good Fit for This Trial?

This trial is for individuals with a BMI over 19 kg/m2 and weight under 250kg who have regained more than 10% of their lost weight after bariatric surgery within the last 1-5 years. They must be in good health, able to follow study rules, and provide their surgery report.

Inclusion Criteria

I am in good health overall and suitable for the study according to my doctor's review.

I am willing to follow the study's rules for its entire duration.

My BMI is over 19 and I weigh less than 250kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

3 visits (in-person)

Treatment

Participants undergo a 12-week high-intensity interval training (HIIT) program

12 weeks

4 sessions per week (combination of in-person and at-home)

Follow-up

Participants are monitored for changes in cognitive function, mood, miRNA profiling, and appetitive behavior

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study examines how high-intensity interval training (HIIT) affects brain function and pathways related to maintaining weight post-obesity treatment, paving the way for new research on obesity interventions.

How Is the Trial Designed?

Group I: Exercise Training Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Joslin Diabetes Center

Lead Sponsor

Trials

98

Recruited

26,500+

Nutrition Obesity Research Center

Collaborator

Trials

5

Recruited

120+

Nutrition Obesity Research Center

Collaborator

Trials

7

Recruited

240+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11856721/

The Effectiveness of High-Intensity Interval Training vs. ... Results: HIIT was found to be most effective for younger individuals (18–30 years), promoting fat oxidation and muscle retention. In middle-aged ...

2. nature.com nature.com/articles/s41598-025-11809-x

Effects of high-intensity interval training on physical fitness ... These findings suggest that HIIT is an effective modality for enhancing cardiorespiratory fitness and reducing body fat percentage in ...

3. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1487789/full

Effects of high intensity interval training and moderate ... The objective of this meta-analysis is to evaluate and compare the effectiveness of HIIT and MICT on enjoyment and affective responses in overweight or obese ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1728869X24000418

Effects of volume-matched once-weekly and thrice ... A meta-analysis by Wewege and colleagues reported that HIIT induced a within-group reduction of 1.7 kg in total body fat mass in overweight and obese adults ...

5. bmjopensem.bmj.com bmjopensem.bmj.com/content/7/3/e001021

Effectiveness of high-intensity interval training for weight ... This study aimed to determine whether a 12-week HIIT was more effective than MICT for weight loss in obese adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12403219/

The effect of high-intensity interval training on health ... The findings indicate that while HIIT does not significantly impact BMI, it has substantial effects on reducing BFP, improving VO2peak, ...

7. apm.amegroups.org apm.amegroups.org/article/view/75370/html

The effect and safety of high-intensity interval training in the ... The results showed that HIIT significantly reduced body weight (MD =−1.73 kg, 95% CI: −3.25 to −0.21, P=0.02) (Figure 4A), BMI (MD =−1.42 kg/m2, 95% CI: −1.98 ...

8. nature.com nature.com/articles/s41366-024-01645-w

Feasibility and efficacy of adding high-intensity interval ... Several studies have provided evidence indicating that high-intensity interval training (HIIT) reduces body weight and improves cardiovascular ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023076107

Effect of high-intensity interval training compared to ... HIIT and MICT did not significantly differ in their effects on weight, BMI, waist circumference, or body fat mass in adults with overweight and obesity.