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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how exercise affects weight management and metabolism. Participants will be divided into two groups: one will follow a regular exercise routine, such as brisk walking, while the other will not exercise. The study will measure metabolic changes before and after a weight loss and regain program. Suitable candidates for this trial are adults with a Body Mass Index (BMI) of 27-45, who haven't exercised regularly for at least six months, and, if women, have steady menstrual cycles. As an unphased trial, this study offers participants the chance to contribute to valuable research on exercise and metabolism.

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 prior data suggests that this exercise program is safe for participants?

Research shows that exercise is generally safe for most people and offers many benefits. Studies have found that regular aerobic exercise, such as brisk walking, can reduce waist size and body fat. It also strengthens bones and improves mood. The World Health Organization states that physical activity is important for a healthy lifestyle and is usually well-tolerated. Moderate exercise routines, like the one used in this study, have not reported serious side effects. However, consulting a doctor before starting any new exercise program is advisable, especially for those with existing health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how exercise alone can be a powerful tool for managing obesity. Unlike traditional options like medication or surgical interventions, this approach focuses on a natural method that involves 45 minutes of moderate-intensity exercise, such as brisk walking, which is accessible and sustainable for many people. This method is distinctive because it emphasizes a consistent, manageable lifestyle change rather than relying on pharmaceuticals or invasive procedures. Additionally, by comparing active exercise with a totally sedentary lifestyle, researchers hope to uncover the most effective strategies for weight management and inspire new, healthier habits.

What evidence suggests that exercise is effective for obesity management?

Research shows that exercise helps people with obesity lose weight and improve body shape. In this trial, participants in the exercise arm will engage in activities like brisk walking. Studies have found that regular brisk walking can significantly reduce body fat and waist size. For example, one study found that 150 minutes of exercise each week led to noticeable weight and fat loss. Another study showed that a 12-week exercise program helped reduce body weight and fat. Overall, exercise is a powerful way to manage obesity and achieve healthier body measurements. Participants in the no-exercise arm will remain sedentary throughout the study. ^{3 4 6 7 8}

Who Is on the Research Team?

Jeffrey F Horowitz, PhD

Principal Investigator

University of Michigan, School of Kinesiology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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