Overseen ByJeffrey F Horowitz, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Must not be taking: Lipid/glucose metabolism, Inflammation
Disqualifiers: Cardiovascular, Metabolic, Tobacco, others
No Placebo Group
Approved in 1 jurisdiction
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.
12345Is 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.
16789How 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.
146910Eligibility 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.
I am between 18 and 40 years old.
+1 more
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.
+2 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: No exerciseExperimental Treatment1 Intervention
Subjects assigned to this group are to remain sedentary (no planned physical exercise) throughout the duration of the study.
Group II: ExerciseExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
References
Physical activity in management of persons with obesity. [2021]Physical activity and exercise have many benefits in persons with obesity, helping with weight loss, body fat loss, abdominal visceral fat loss and possibly with weight maintenance after weight loss. The effect of exercise training (endurance or endurance plus resistance or high-intensity interval training) alone on weight loss as outcome appears relatively modest, amounting to only a few kg. However, endurance training during weight loss has been shown to increase V̇O2max and resistance training during weight loss leads to lower loss in lean body mass and increased muscle strength. In addition, higher physical activity levels improve cardiovascular risk, whatever weight variations. Specifically, physical activity or exercise is part of lifestyle measures for prevention of type 2 diabetes and substantially helps with metabolic control in patients with type 2 diabetes. The importance of physical activity counselling and exercise prescription in the management strategy will depend on specific treatment objectives as defined for a given patient, including weight loss, prevention of weigh regain, prevention of cardio-metabolic comorbidities, lean body mass preservation but also improvement in quality of life or development of social links. The 5 A's strategy consisting in: Ask, Assess, Advise, Agree, Assist (or Arrange) appears well adapted in this setting. Professionals need to be aware of the many barriers patients with obesity may meet on their way to increase habitual physical activity as specific solutions should be proposed. A major challenge is how to improve adherence to new physical activity habits over time.
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]The benefits of exercise in patients with obesity are clear; physical performance and quality of life improve after exercise programs in patients with obesity. Our aim was to evaluate the usefulness of an easy, structured, and home-based exercise program to improve physical performance and quality-of-life in patients with obesity.
[Physical activity and management of obese patients]. [2016]Physical activity is recognized as an integral part of obesity treatment, in association with other therapeutic means. A major benefit of physical activity is the association with better long-term maintenance of weight loss. Physical activity has also positive psychological effects and increases quality of life. An evaluation of the usual level of physical activity and inactivity is needed for each patient. Physical activity counselling should be individualized and graded, in a perspective of individual progression. In subjects with massive obesity, remobilization based on physiotherapy techniques is the first step. All patients should be given simple advice to decrease sedentary behavior: use the stairs instead of the escalators, limit the time spent seated, etc. In general, current physical activity recommendations for the general population fit well with a majority of obese patients, i.e. a minimum of 30 minutes/day of moderate intensity physical activity (brisk walking or equivalent) on most, and preferably all, days of the week. Physical activities of higher intensities (endurance training programme) can be proposed on an individual basis. The type of physical activity required for long-term weight maintenance, and the question of adherence to physical activity recommendations in obese patients should be further investigated.
Effects of physical training on anthropometrics, physical and physiological capacities in individuals with obesity: A systematic review. [2021]Increasing the amount of physical activity is an important strategy for weight loss. This systematic review summarizes recent findings on the effects of physical training on anthropometric characteristics, physical performances and physiological capacities in individuals with overweight and obesity. A systematic literature search strategy was conducted from inception until June 2019 using four electronic databases that identified 2,708 records. After screening for titles, abstracts and full texts, 116 studies were included in our final analysis. Both aerobic (e.g., endurance training) and anaerobic training (e.g., high-intensity training, resistance training) improved body composition and physical fitness indicators in adults, adolescents and children with obesity (effect size: 0.08 < d < 2.67, trivial to very large). This systematic review suggests that both low- and high-intensity training significantly reduced body weight and fat mass while increasing fat-free mass in individuals with obesity (effect size: 0.04 <d <3.2, trivial to very large). A significant increase in VO2max also occurs in individuals with obesity in response to aerobic training or high-intensity interval training (effect size: 0.13 < d < 6.24, trivial to very large). Further studies are needed to define the optimal combination of training intensity and duration needed to produce the most efficacious results in individuals with obesity.
The future of obesity reduction: beyond weight loss. [2021]Obesity increases the risk of morbidity and mortality and reduces quality of life independent of age, sex or ethnicity. Leading health authorities recommend weight loss as a primary treatment strategy for obesity reduction--weight loss goals range from 5% to 10% of initial body weight. Intentional weight loss in most adults is associated with a reduction in many of the health complications of obesity. Nonetheless, emerging evidence supports the notion that a lifestyle-modification program characterized by an increase in physical activity and a balanced diet can reduce obesity and the risk of obesity-related comorbid conditions despite minimal or no weight loss. The benefits of such an approach include appreciable reductions in abdominal obesity, visceral fat and cardiometabolic risk factors, and increases in both skeletal muscle mass and cardiorespiratory fitness. Individuals with obesity face a serious challenge if they are to attain even modest weight loss in today's obesogenic environment. Clinicians could encourage positive lifestyle changes in their patients by counseling them that obesity and its associated health risks can be reduced in response to an increase in physical activity with or without weight loss.
Exercise therapy for the exercise naïve: The first step in obesity management. [2022]Exercise is an integral part of obesity management and health promotion. This brief communication shares practical and pragmatic tips as to how to initiate physical activity in an exercise-naïve person with obesity. This information will be useful for all health care professionals who manage patients with obesity, including physicians and physiotherapists. A step-wise initiation of physical activity starting from flexibility training, balance practice and then aerobic and resistance exercises would help to provide a long term sustainable pattern of physical activity.
Physical exercise and morbid obesity: a systematic review. [2019]Physical exercise is an important component for the treatment of obesity. Little information is available about the best and safety form of physical exercise concerning the type and volume-intensity to be prescribed for individuals with morbid obesity.
Obesity and physical exercise. [2021]Obesity represents a major health problem worldwide and is associated with increased prevalence of numerous health-related conditions, including diabetes, hypertension, cardiovascular disease, some forms of cancer and musculoskeletal disorders, among others. Studies that have examined the impact of physical exercise combined with energy restriction diets on weight have shown greater weight loss compared to interventions of exercise-only. Accordingly, the most effective approach to achieve significant weight loss includes a combination of diet, exercise and behavioral strategies. Current guidelines recommend participating in at least 150 minutes of moderate-intensity or 75 minutes of vigorous intensity aerobic exercise weekly, and resistance/muscle strengthening training, involving all major muscle groups at least twice a week. For patients seeking to maintain weight loss, high levels of exercise (225-420 min/week of moderate intensity exercise) have been associated with improved weight maintenance compared to lower levels (
Effect of exercise on obesity. [2019]The changes in fitness and body composition which accompany physical training in people of normal weight would be very valuable in the treatment of obesity. However, one of the most marked disabilities arising from obesity is a reduced exercise tolerance, so severely obese patients are unable to perform the exercise which would bring these benefits. It has been suggested that exercise may confer benefits on the obese person by reducing voluntary food intake, or by causing a prolonged elevation of metabolic rate. There is no good evidence for these claims. Obesity is best treated by a combination of dietary restriction and exercise: the more severe the obesity the more important the diet component of treatment, but exercise becomes more important with the management of mild obesity or the prevention of obesity.
Exercise in the management of obesity. [2019]Obesity is a multifactorial disease with increasing incidence and burden on societies worldwide. Obesity can be managed through everyday behavioral changes involving energy intake and energy expenditure. Concerning the latter, there is strong evidence that regular exercise contributes to body weight and fat loss, maintenance of body weight and fat reduction, and metabolic fitness in obesity. Appropriate exercise programs should ideally combine large negative energy balance, long-term adherence, and beneficial effects on health and well-being. Endurance training appears to be the most effective in this respect, although resistance training and high-intensity interval training play distinct roles in the effectiveness of exercise interventions. With weight regain being so common, weight loss maintenance is probably the greatest challenge in the successful treatment of obesity. There is an established association between higher levels of physical activity and greater weight loss maintenance, based on the abundance of evidence from prospective observational studies and retrospective analyses. However, proving a causative relationship between exercise and weight loss maintenance is difficult at present. Exercise has the potential to alleviate the health consequences of obesity, even in the absence of weight loss. All in all, exercise constitutes an indispensable, yet often underestimated, tool in the management of obesity.