An interventional study of Diet and Aerobic Exercise in Obesity and Overweight, sponsored by University of Kansas Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
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:
Participants will:
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 290 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Diet · Behavioral: Aerobic Exercise · Behavioral: Behavioral Sessions
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.
Behavioral: Diet · Behavioral: Behavioral Sessions · Behavioral: Aerobic + Yoga Exercise
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.
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 to assist in supporting recommended changes in energy intake (diet) and physical activity.
Physical activity will be recommended in the form of a combination of aerobic types of activity, such as brisk walking, and yoga. Aerobic activity will progress from 60 minutes per week to 180 minutes per week across the initial 6 months of the intervention. Yoga will progress from 40 minutes per week to 120 minutes per week across the initial 6 months of the intervention. When combined this will progress from a total of 100 minutes per week to 300 minutes per week across the initial 6 months of treatment. This level of physical activity will continue to be recommended between months 7-12.
Body Weight
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
Time frame: 0, 3, 6, 9, 12 months
Body Mass Index
Measurements of weight and height will be used to compute BMI (kg/m2).
Time frame: 0, 3, 6, 9, 12 months
Percent body fat
Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Time frame: 0, 6, 12 months
Body Fat Mass
Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Time frame: 0, 6, 12 months
Lean Body Mass
Lean body mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Time frame: 0, 6, 12 months
Bone mineral content
Bone mineral content (grams) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Time frame: 0, 6, 12 months
Waist Circumference
Circumference measures of the waist taken horizontally at both the iliac crest and the umbilicus will be performed.
Time frame: 0, 6, 12 months
Cardiorespiratory Fitness
Cardiorespiratory fitness will be represented as milliliters of oxygen consumed per kilogram of body weight per minute (ml/kg/min) measured with a metabolic cart during a submaximal graded exercise test that is terminated when the participant achieves 85% of age-predicted maximal heart rate.
Time frame: 0, 6, 12 months
Cardiorespiratory Fitness
Cardiorespiratory fitness will be represented as total liters of oxygen consumed per minute (L/min) measured with a metabolic cart during a submaximal graded exercise test that is terminated when the participant achieves 85% of age-predicted maximal heart rate.
Time frame: 0, 6, 12 months
Cardiorespiratory Fitness
Cardiorespiratory fitness will be the duration measured in minutes to achieve 85% of age-predicted maximal heart rate during a submaximal graded exercise test performed on a treadmill.
Time frame: 0, 6, 12 months
Energy Intake (Dietary Intake)
Energy Intake (Dietary Intake) expressed as kilocalories eaten per day (kcal/day) will be measured using the Diet History Questionnaire (DHQ) developed by NCI. A higher score represents more calories eaten.
Time frame: 0, 3, 6, 9, 12 months
Dietary Cognitive Restraint
Dietary cognitive restraint will be measured using from 21 items on the 3-Factor Eating Questionnaire. The range of possible scores is 0 to 20, with a higher score representing high dietary cognitive restraint.
Time frame: 0, 3, 6, 9, 12 months
Dietary Disinhibition
Dietary disinhibition will be measured using from 16 items on the 3-Factor Eating Questionnaire. The range of possible scores is 0 to 16, with a higher score representing high dietary disinhibition.
Time frame: 0, 3, 6, 9, 12 months
Hunger
Hunger will be measured using from 15 items on the 3-Factor Eating Questionnaire. The range of possible scores is 0 to 15, with a higher score representing high hunger.
Time frame: 0, 3, 6, 9, 12 months
Weight Loss Strategies
Weight Loss Strategies will be measured using the Weight Control Strategies Scale that includes 30 items. A higher score represents engaging in more weight control strategies.
Time frame: 0, 3, 6, 9, 12 months
Weight Loss Strategies
Weight Loss Strategies will be measured using the Eating Behavior Inventory that includes 26 items with each measured on a 5-point scale. A higher score represents engaging in more weight loss strategies.
Time frame: 0, 3, 6, 9, 12 months
Mood/Affect
The Positive and Negative Affect Schedule (PANAS) will be used to assess mood/affect which includes 20 items measured on a 5-point scale. A higher score represents a higher degree of either positive or negative affect.
Time frame: 0, 3, 6, 9, 12 months
Perceived Stress
Perceived Stress Scale (PSS) will assess a global appraisal of perceived stress, which includes 10 items each score on a 5-point scale. A higher score represents higher perceived stress.
Time frame: 0, 3, 6, 9, 12 months
Depressive Symptoms
Centers for Epidemiological Studies Depression Scale (CES-D) will assess depressive symptoms. This includes 10 items scored on a scale of 0-4, with a higher score representing higher depressive symptoms.
Time frame: 0, 3, 6, 9, 12 months
Mindfulness
The Mindful Attention Awareness Scale is used to measure mindfulness. It contains 15 items scored on a 1-6 scale, and a higher score represents more mindfulness.
Time frame: 0, 3, 6, 9, 12 months
Mindfulness Practice
The Five-Facet Mindfulness Questionnaire will be used to assess mindfulness and mindfulness practice. It contains 39 items scored on a 5-point scale, and a higher score represents more mindfulness practice.
Time frame: 0, 3, 6, 9, 12 months
Sleep
Sleep will be assessed using the Pittsburgh Sleep Quality Index. The sum of 7 domains, each scored on a 0-3 scales, provide a total score that ranges from 0-21. A higher score indicates greater sleep disturbance.
Time frame: 0, 3, 6, 9, 12 months
Acute Physical Activity Test - perceived distress
Perceived distress will be measured using a questionnaire that includes 12 items scored on a 7-point scale.
Time frame: Between weeks 2-6, at 6 months, at 12 months
Acute Physical Activity Test - Mood
Mood will be measured using a questionnaire. The Positive and Negative Affect Schedule (PANAS) will be used to assess mood/affect which includes 20 items measured on a 5-point scale. A higher score represents a higher degree of either positive or negative affect.
Time frame: Between weeks 2-6, at 6 months, at 12 months
Acute Physical Activity Test - Sleepiness
Sleepiness will be measured using on a 9-point scale with a higher score representing more sleepiness.
Time frame: Between weeks 2-6, at 6 months, at 12 months
Acute Physical Activity Test - Hunger
Hunger will be measured using a 100 mm visual analog scale, with a higher score representing more hunger.
Time frame: Between weeks 2-6, at 6 months, at 12 months
Acute Physical Activity Test - Cortisol
Cortisol will be measured from a blood sample using a commercially available assay.
Time frame: Between weeks 2-6, at 6 months, at 12 months
Medication History
A questionnaire developed specifically for this study will be used to assessment medication history. The data collected include the type of medication, dose of medication, and frequency that the medication is taken, and what condition the medication is indicated to treat.
Time frame: 0, 3, 6, 9, 12 months
Lifestyle and Health History
A questionnaire developed specifically for this study that is conducted as an interview will be used to assess lifestyle and health factors to describe the sample for this study. The score is either "yes" or "no" identifying the presences of a lifestyle or health factor.
Time frame: 0 months (prior to randomization)
Adverse and Serious Adverse Events
Participants will be queried using a survey developed specifically for this study will be used to assess for adverse events and serious adverse events.
Time frame: 0, 3, 6, 9, 12 months and at other times when reported by the participant
Plan to share: Yes — The summary data for each of the study outcomes and other additional demographic characteristics will be made available. The Study Protocol (which includes the statistical analysis plan), Manual of Procedures, Data Collection Forms, and a Data Dictionary to explain the data variables will be provided.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Kansas Medical Center