Exercise for Obesity Management

(LG Trial)

Overseen By Suzette Howton

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Lipid/glucose metabolism, Inflammation

Disqualifiers: Cardiovascular, Metabolic, Tobacco, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

46 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.

Will I have to stop taking my current medications?

The trial excludes participants who are taking medications that affect lipid (fat) or glucose (sugar) metabolism, or inflammation. If you are on such medications, you may need to stop taking them to participate.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training, No exercise for obesity management?

Research shows that exercise and physical activity help with weight loss, reduce body fat, and improve physical performance and quality of life in people with obesity. Even without significant weight loss, increased physical activity can reduce health risks associated with obesity, such as cardiovascular issues, and improve muscle strength and fitness. ^{1 2 3 4 5}

Is exercise safe for managing obesity?

Exercise is generally safe for managing obesity and has many health benefits, including weight loss and improved cardiovascular health. However, it's important to start gradually, especially for those who are new to exercise, and to follow guidelines for the type and amount of exercise to ensure safety. ^{1 6 7 8 9}

How does the treatment of exercise differ from other treatments for obesity?

Exercise is unique in obesity management because it not only aids in weight and fat loss but also improves cardiovascular health and muscle strength, even without significant weight loss. Unlike other treatments, exercise can enhance metabolic fitness and help maintain weight loss over time, making it a crucial component of a sustainable lifestyle change. ^{1 4 6 9 10}

Research Team

Jeffrey F Horowitz, PhD

Principal Investigator

University of Michigan, School of Kinesiology

Eligibility Criteria

This trial is for adults aged 18-40 with a BMI of 27-45 who haven't been exercising regularly. Women should have regular menstrual cycles and not be pregnant or breastfeeding. People can't join if they've had heart or metabolic diseases, take meds affecting metabolism, had recent weight fluctuations, or use tobacco products.

Inclusion Criteria

You haven't been doing regular exercise or physical activity for at least 6 months.

I am a woman who has regular menstrual cycles and am not in menopause.

Your body mass index (BMI) is between 27 and 45.

Exclusion Criteria

Your weight has changed by more than 6 pounds in the last 3 months.

I am not pregnant or breastfeeding.

You use tobacco or e-cigarettes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Weight Loss Program

Participants undergo a 10% weight loss program with or without exercise training depending on group randomization

12-16 weeks

Weekly visits (in-person)

Weight Regain Program

Participants adhere to a high calorie diet program to regain half of the weight lost, followed by metabolic tests

8-12 weeks

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the weight regain program

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Exercise
• No exercise

Trial Overview The study is testing the impact of exercise on body fat and how it functions after weight loss. Participants will either follow an exercise program or no exercise while losing and then regaining weight. Their metabolic health will be tested before and after these changes.

Participant Groups

Group I: No exercise Experimental Treatment 1 Intervention

Subjects assigned to this group are to remain sedentary (no planned physical exercise) throughout the duration of the study.

Group II: Exercise Experimental Treatment 1 Intervention

This exercise prescription represents a common or "conventional" form of physical activity (e.g., moderate/brisk walking). If assigned to this group, participants will perform 45 minutes of moderate intensity continuous steady-state exercise at 70% maximal heart rate (HRmax) to expend 250 calories 4 days per week.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

Exercise has numerous benefits for individuals with obesity, including aiding in weight loss and improving cardiovascular health, but the direct impact on weight loss from exercise alone is modest, typically resulting in only a few kilograms of weight loss.

Physical activity is crucial for managing type 2 diabetes and preventing its complications, and a structured approach like the 5 A's strategy can help healthcare professionals effectively support patients in overcoming barriers to increasing their physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in management of persons with obesity. Oppert, JM., Bellicha, A., Ciangura, C.[2021]

A structured, home-based exercise program significantly improved physical performance and quality of life in patients with obesity, as demonstrated by a cohort of 151 participants over a 3-month period.

After the program, participants showed notable enhancements in walking distance, speed, and VO2max, indicating that even simple exercise routines can have substantial health benefits for individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of an Easy, Structured, and Home-Based Exercise Program to Improve Physical Performance and Quality of Life in a Patient's Cohort with Obesity. López-López, CO., Montes Castillo, ML., Aguilar-Serralde, CA., et al.[2023]

Physical activity is crucial for effective obesity treatment, as it not only aids in weight loss maintenance but also improves psychological well-being and quality of life.

Current recommendations suggest that obese patients should aim for at least 30 minutes of moderate-intensity physical activity most days of the week, with individualized counseling to help reduce sedentary behavior and promote adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity and management of obese patients]. Oppert, JM., Balarac, N.[2016]

A systematic review of 116 studies found that both aerobic and anaerobic training significantly improve body composition and physical fitness in individuals with obesity, with effect sizes ranging from trivial to very large.

Physical training not only reduces body weight and fat mass but also increases fat-free mass and VO2max, indicating enhanced cardiovascular fitness, suggesting that various intensities of exercise can be beneficial for weight loss and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of physical training on anthropometrics, physical and physiological capacities in individuals with obesity: A systematic review. Zouhal, H., Ben Abderrahman, A., Khodamoradi, A., et al.[2021]

A lifestyle-modification program that includes increased physical activity and a balanced diet can significantly reduce obesity-related health risks, even if there is minimal or no weight loss.

Such lifestyle changes can lead to improvements in abdominal obesity, visceral fat, and cardiometabolic risk factors, as well as increases in muscle mass and cardiorespiratory fitness, highlighting the importance of focusing on health improvements rather than just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future of obesity reduction: beyond weight loss. Ross, R., Bradshaw, AJ.[2021]

Exercise is crucial for managing obesity and promoting health, and this communication provides practical tips for starting physical activity in individuals who are new to exercise.

A gradual approach to initiating physical activity—beginning with flexibility and balance training before progressing to aerobic and resistance exercises—can help establish a sustainable long-term exercise routine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy for the exercise naïve: The first step in obesity management. Kalra, S., Mandlekar, A., Kapoor, N.[2022]

A systematic review of 13 studies found that both aerobic and strength exercises are crucial for effectively treating individuals with morbid obesity, whether they are undergoing medical or surgical interventions.

It is essential to tailor the volume and intensity of exercise programs to ensure patient adherence, highlighting the need for individualized exercise plans for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise and morbid obesity: a systematic review. Fonseca-Junior, SJ., Sá, CG., Rodrigues, PA., et al.[2019]

Combining physical exercise with energy restriction diets leads to greater weight loss than exercise alone, making it the most effective strategy for significant weight loss.

Engaging in at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic exercise weekly, along with resistance training, is recommended for weight loss and maintenance, which also helps improve obesity-related health issues like diabetes and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and physical exercise. Celik, O., Yildiz, BO.[2021]

Exercise can be beneficial for obese individuals, but many are unable to tolerate physical activity due to their weight, which limits their ability to gain fitness and improve body composition.

The most effective treatment for obesity combines dietary restriction and exercise, with a greater emphasis on diet for those with severe obesity and a focus on exercise for managing mild obesity or preventing weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise on obesity. Garrow, JS.[2019]

Regular exercise is crucial for managing obesity, contributing to weight loss, maintenance, and improved metabolic health, with endurance training being the most effective type of exercise.

Higher levels of physical activity are associated with better weight loss maintenance, although establishing a direct cause-and-effect relationship remains challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in the management of obesity. Petridou, A., Siopi, A., Mougios, V.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity in management of persons with obesity. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Usefulness of an Easy, Structured, and Home-Based Exercise Program to Improve Physical Performance and Quality of Life in a Patient's Cohort with Obesity. [2023]

3. France pubmed.ncbi.nlm.nih.gov

[Physical activity and management of obese patients]. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Effects of physical training on anthropometrics, physical and physiological capacities in individuals with obesity: A systematic review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The future of obesity reduction: beyond weight loss. [2021]

6. Pakistan pubmed.ncbi.nlm.nih.gov

Exercise therapy for the exercise naïve: The first step in obesity management. [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

Physical exercise and morbid obesity: a systematic review. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

Obesity and physical exercise. [2021]

9. Sweden pubmed.ncbi.nlm.nih.gov

Effect of exercise on obesity. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Exercise in the management of obesity. [2019]