This clinical trial compares the effect of adding yoga to behavioral weight loss interventions including diet and aerobic exercise to diet and aerobic exercise alone on weight loss and other measures of health in obese and overweight adults. Excess body weight and an unhealthy amount of body fat (obesity) is associated with a number of adverse health consequences including cardiovascular disease and the number of overweight and obese adults have been increasing at a rapid rate in the United States. Most behavioral weight loss interventions typically include aerobic forms of exercise and have been shown to improve weight loss when compared to diet changes alone. Eating a diet low in total calories and fat may prevent the development of some conditions including heart disease and some weight related cancers. Aerobic exercise is physical activity that increases the heart rate and the body's use of oxygen. It helps improve a person's physical fitness. Yoga is an ancient system of practices used to balance the mind and body through exercise, meditation (focusing thoughts), and control of breathing and emotions and is thought to further enhance weight loss efforts. Adding yoga to diet and aerobic exercise may be more effective than diet and aerobic exercise alone in improving weight loss in overweight and obese patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06636773.
Locations matching your search criteria
United States
Kansas
Kansas City
University of Kansas Cancer CenterStatus: Active
Contact: John M. Jakicic
Phone: 913-588-9078
PRIMARY OBJECTIVES:
I. To examine the effect of behavioral weight loss intervention (BWI)+ aerobic physical activity (AER) versus (vs.) BWI+AER+YOGA on 12-month weight loss.
II. To examine BWI+AER+YOGA compared to BWI+AER on physical activity engagement, which includes yoga.
III. To compare body composition, fitness, and strength between BWI+AER+YOGA and BWI+AER.
IV. To compare resting blood pressure between BWI+AER+YOGA and BWI+AER.
V. To compare eating behaviors and diet between BWI+AER+YOGA and BWI+AER.
VI. To compare BWI+AER+YOGA and BWI+AER potential psychological/mental health benefits that may be realized with different forms of exercise.
VII. To conduct moderation analyses to examine moderators (e.g., sex, race/ethnicity, etc.) of the effectiveness of our interventions on weight change and other outcomes.
VIII. A substudy of a subsample of participants will also be conducted to examine the acute effects of the different forms of exercise on blood glucose across the acute exercise session conducted during the early phase of the intervention and/or following at 6 months of the intervention.
OUTLINE: Patients are randomized to 1 of 2 conditions.
CONDITION I (BWI+AER): Patients attend group meetings over 60-90 minutes once weekly (QW) for 6 months then twice monthly during months 7-12 and receive access to the Healthie, trademark app. Patients follow a diet with reduced total calories and fat and participate in moderate intensity aerobic exercise over 20-60 minutes 5 days per week for 12 months. Patients also wear a physical activity tracker throughout the study. Additionally, patients undergo blood sample collection and dual X-ray absorptiometry (DXA) throughout the study.
CONDITION II (BWI+AER+YOGA): Patients attend group meetings over 60-90 minutes QW for 6 months then twice monthly during months 7-12 and receive access to the Healthie, trademark app. Patients follow a diet with reduced total calories and fat and participate in moderate intensity aerobic exercise over 20-60 minutes thrice weekly and yoga exercises over 20-60 minutes twice weekly for 12 months. Patients also wear a physical activity tracker throughout the study. Additionally, patients undergo blood sample collection and DXA throughout the study.
After completion of study intervention, patients are followed up at 1 month.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorJohn M. Jakicic
