Aerobic vs. Aerobic + Yoga Exercise for Obesity

Recruiting in Palo Alto (17 mi)

Overseen by John M. Jakicic, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Kansas Medical Center

Must not be taking: Anti-obesity medications

Disqualifiers: Pregnancy, Bariatric surgery, Cardiovascular, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn whether adding yoga exercise to a behavioral weight loss intervention improves weight loss in adults with overweight or obesity. It will also provide information about whether this approach to weight loss has additional benefits on other health and fitness measurements. The main questions it aims to answer are: * Is there a difference in weight loss between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? * Is there a difference in how much physical activity is completed between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? * Is there a difference in the change in body composition (fat mass, lean body mass) between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? * Is there a difference in the change in cardiorespiratory fitness the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? * Is there a difference in the change in muscle strength between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? * Is there a difference in the change in resting blood pressure between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? * Is there a difference in the change in food intake or eating behaviors between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? * Is there a difference in the change in feelings of stress or mood between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? * Is there a difference in the change in sleep between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? * Is there a difference in the change in mindfulness between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? Participants will: * Participate in a weight loss program for a period of 12 months that involves attending behavioral weight loss sessions. This involves coming to a session at the research center weekly for the initial 6 months and then every other week for the remaining 6 months. * Attempt to reduce the amount of food that they eat to reduce the calories they consume. * Participate in a combination of aerobic exercise plus yoga or just aerobic exercise. * Keep a record of the food they consume, use a digital scale provided to them, and wear an activity tracker provided to them for the period of 12 months. * Visit the clinical before starting the weight loss program, after 3 months, 6 months, 9 months, and 12 months to complete measurements of their weight and other measurements to monitor their progress. * Complete exercise sessions in the clinic between weeks 2-6, at month 6, and at month 12 to provide information about how they response to a single session of exercise.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anti-obesity medication, you cannot participate in the trial.

What data supports the effectiveness of the treatment Aerobic + Yoga Exercise for obesity?

Research shows that both yoga and aerobic exercise can improve quality of life and reduce obesity-related measures like body mass index (BMI) and waist circumference. Combining these activities may enhance these benefits, as yoga can also promote healthy eating and provide social support, which are important for weight loss. ^{1 2 3 4 5}

Is Aerobic + Yoga Exercise safe for humans?

Research shows that both yoga and aerobic exercise are generally safe for humans, with no significant differences in serious adverse events compared to usual care or exercise. However, yoga may have more nonserious adverse events compared to psychological or educational interventions. ^{2 5 6 7 8}

How does the Aerobic + Yoga Exercise treatment for obesity differ from other treatments?

The Aerobic + Yoga Exercise treatment is unique because it combines traditional aerobic exercise with yoga, which may enhance weight loss and improve quality of life by incorporating both physical activity and mindfulness practices. This dual approach can offer benefits such as improved flexibility, stress reduction, and a more holistic lifestyle change compared to standard exercise or diet plans alone. ^{2 3 5 9 10}

Research Team

John M. Jakicic, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for adults with overweight or obesity who want to lose weight. Participants will join a 12-month behavioral weight loss program, which includes dieting, exercise sessions, and health monitoring. They must be willing to reduce food intake, attend regular sessions at the research center, and keep track of their eating and activity.

Inclusion Criteria

I can understand and agree to the study's terms on my own.

Participants must have the ability to provide clearance from their primary care physician to engage in the diet and physical activity components of the weight loss intervention.

I am eligible regardless of my gender or ethnicity.

Exclusion Criteria

Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.

I have had weight loss surgery in the past.

Report moderate-to-vigorous exercise on more than 3 days/week or a total of more than 60 min/week over the past 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-month behavioral weight loss program with either aerobic exercise or aerobic exercise plus yoga, including weekly sessions for the first 6 months and bi-weekly sessions for the remaining 6 months.

12 months

Weekly visits for 6 months, then bi-weekly visits for 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with measurements taken at 3, 6, 9, and 12 months.

12 months

Visits at 3, 6, 9, and 12 months

Treatment Details

Interventions

• Aerobic + Yoga Exercise (Behavioural Intervention)

Trial Overview The study compares two approaches: one group does aerobic exercise only while the other combines aerobic with yoga as part of their weight loss program. It looks at differences in weight loss, physical activity levels, body composition changes, fitness improvements including muscle strength and cardiorespiratory function, mood and stress levels, sleep quality, mindfulness practices and dietary behaviors.

Participant Groups

Group I: Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga Experimental Treatment 3 Interventions

The intervention is a 12-month behavioral intervention focused on modifying eating behaviors and physical activity. Participants will be provided weekly group-based behavioral session for months 1-6, with these sessions being offered twice per month during months 7-12. Participants will be instructed to self-monitor their weight, eating behaviors, and physical activity. A reduced energy diet ranging from 1200-2100 kilocalories per day will be recommended for participants. Physical activity will be recommended in the form of aerobic types of activity such as brisk walking combined with yoga. Aerobic activity will progress from an initial amount of 60 minutes per week to 180 minutes per week across the initial 6 months of the intervention, with this level continuing to be recommended between months 7-12. Yoga will progress from 40 minutes per week to 120 minutes per week across the initial 6 months of the intervention, with this level continuing to be recommended between months 7-12.

Group II: Behavioral Weight Loss Plus Aerobic Physical Activity Experimental Treatment 3 Interventions

The intervention is a 12-month behavioral intervention focused on modifying eating behaviors and physical activity. Participants will be provided weekly group-based behavioral session for months 1-6, with these sessions being offered twice per month during months 7-12. Participants will be instructed to self-monitor their weight, eating behaviors, and physical activity. A reduced energy diet ranging from 1200-2100 kilocalories per day will be recommended for participants. Physical activity will be recommended in the form of aerobic types of activity such as brisk walking and will progress from an initial amount of 100 minutes per week to 300 minutes per week across the initial 6 months of the intervention, with this level of physical activity continuing to be recommended between months 7-12.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Dr. Steve Stites

University of Kansas Medical Center

Chief Executive Officer

MD from University of Kansas School of Medicine

Dr. Matthias Salathe

University of Kansas Medical Center

Chief Medical Officer

MD from University of Kansas School of Medicine

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

A short-term yoga-based lifestyle intervention significantly improved health-related quality of life (HRQOL) in overweight and obese individuals, with positive changes observed in physical, psychological, and environmental domains after just 10 days.

Participants also experienced notable reductions in body weight, BMI, and various health markers such as blood pressure and cholesterol levels, indicating both efficacy and potential health benefits of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Short-Term Yoga-Based Lifestyle Intervention on Health-Related Quality of Life in Overweight and Obese Subjects. Yadav, R., Yadav, RK., Pandey, RM., et al.[2022]

In a study of 596 Asian Indian obese adults, those with at least one month of yoga experience reported significantly better quality of life in areas such as enjoyment of physical activities, work ability, self-esteem, and social satisfaction compared to those who had never practiced yoga.

The findings suggest that incorporating yoga into weight management programs may enhance quality of life, which is crucial for sustained weight loss efforts in individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life in Yoga Experienced and Yoga Naïve Asian Indian Adults with Obesity. Telles, S., Sharma, SK., Singh, A., et al.[2020]

In a study involving 73 patients with severe obesity, both moderate-intensity continuous training (MICT) and a combined high-intensity interval training with MICT (HIIT/MICT) program led to significant improvements in health-related quality of life (HRQOL) after 24 weeks, with no significant difference between the two exercise intensities.

Both exercise programs resulted in moderate improvements in various quality of life measures, indicating that the benefits of exercise on health may not depend on the intensity of the workout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial. Berge, J., Hjelmesæth, J., Kolotkin, RL., et al.[2022]

Yoga interventions can lead to significant improvements in obesity-related outcomes such as BMI, body weight, and waist circumference, suggesting its potential as a weight loss tool.

Qualitative interviews revealed that participants experienced not only physical changes but also psychological benefits and a shift towards healthier eating, highlighting the importance of community support in the weight loss journey through yoga.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Different Weight Loss Experience: A Qualitative Study Exploring the Behavioral, Physical, and Psychosocial Changes Associated with Yoga That Promote Weight Loss. Ross, A., Brooks, A., Touchton-Leonard, K., et al.[2020]

A 12-week study involving 82 physically inactive older adults showed that both yoga and aerobic exercise significantly improved wellbeing compared to a wait-list control group, with medium to large effect sizes.

Yoga resulted in fewer adverse events (22% injury rate) compared to aerobic exercise (37% injury rate), suggesting it may be a safer option for older adults looking to enhance their wellbeing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of yoga and aerobic exercise on wellbeing in physically inactive older adults: Randomized controlled trial (FitForAge). Welford, P., Östh, J., Hoy, S., et al.[2022]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

Participants in yoga sessions achieved moderate-intensity aerobic activity for an average of 32.75% of the class duration, indicating that yoga can contribute to meeting the Physical Activity Guidelines for Americans.

The study found that factors like tempo and temperature did not significantly affect the intensity of the yoga sessions, suggesting that both Hatha and Vinyasa yoga classes can effectively help adults and older adults fulfill their aerobic activity requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Temperature and Tempo: Evaluating How Much Time in a Typical Community-Based Yoga Class Is Moderate-Intensity Aerobic Activity. Dysart, A., Harden, SM.[2023]

In a randomized controlled trial involving 31 morbidly obese participants, both aerobic training (AT) and resistance training (RT) significantly improved health-related fitness measures compared to a control group, including enhancements in walking distance, skin-fold thickness, and psychological factors like self-efficacy.

RT showed additional benefits over the control group in reducing BMI and waist circumference, indicating that while both exercise types are effective, resistance training may offer extra advantages in certain anthropometric measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of 12 weeks supervised exercise in obesity management. Herring, LY., Wagstaff, C., Scott, A.[2015]

A 6-month pilot study with 14 overweight or obese sedentary adults showed that a yoga program can significantly increase physical activity levels over time, suggesting it may help individuals transition to regular exercise.

Participants using a self-learning DVD method reported higher physical activity levels compared to those receiving face-to-face instruction, particularly at the 4-month mark, indicating that self-guided approaches may be effective for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga, as a transitional platform to more active lifestyle: a 6-month pilot study in the USA. Yang, K., James, KA.[2018]

References

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

Effect of a Short-Term Yoga-Based Lifestyle Intervention on Health-Related Quality of Life in Overweight and Obese Subjects. [2022]

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

Quality of Life in Yoga Experienced and Yoga Naïve Asian Indian Adults with Obesity. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial. [2022]

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

A Different Weight Loss Experience: A Qualitative Study Exploring the Behavioral, Physical, and Psychosocial Changes Associated with Yoga That Promote Weight Loss. [2020]

5. Nepal pubmed.ncbi.nlm.nih.gov

Comparison of Effect of Yoga versus Aerobic Exercise on Waist Circumference, Waist-Hip Ratio and Body Mass Index in Overweight and Obese Adult Individuals. [2022]

6. Scotland pubmed.ncbi.nlm.nih.gov

Effects of yoga and aerobic exercise on wellbeing in physically inactive older adults: Randomized controlled trial (FitForAge). [2022]

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

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Temperature and Tempo: Evaluating How Much Time in a Typical Community-Based Yoga Class Is Moderate-Intensity Aerobic Activity. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The efficacy of 12 weeks supervised exercise in obesity management. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Yoga, as a transitional platform to more active lifestyle: a 6-month pilot study in the USA. [2018]