Obesity and OverweightNCT06636773
Comparision of Aerobic Exercise to Aerobic Plus Yoga Exercise for Weight Loss in Adults With Overweight or Obesity.
A study testing Diet, Aerobic Exercise and Behavioral Sessions in people with Obesity and Overweight, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Diet, Aerobic Exercise and Behavioral Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both males and females of all race/ethnic groups are eligible for participation in this study.
- at least 18 years of age. The investigators will not limit enrollment based on an upper age provided that the participant meets the other eligibility requirements.
- Body mass index (BMI) of at least 25.0 kg/m2. The investigators will not limit enrollment based on an upper BMI level provided that the participant meets the other eligibility requirements. However, maximal weight to be eligible will be 350 pounds to meet the weight requirements for the equipment that will be used in this study.
- Ability to provide informed consent prior to participation in this study.
- Ability to provide clearance from their primary care physician to engage in the diet and physical activity components of the weight loss intervention.
Who cannot join
- Report moderate-to-vigorous exercise on \>3 days/week or a total of \>60 min/week over the past 3 months.
- Engaging in any style of yoga on an average of at least 1 day/week over the past 3 months.
- Report weight loss of 3% or more or participating in a weight reduction diet in the past 3 months.
- Currently prescribed an anti-obesity medication.
- Females who are pregnant or breastfeeding or reporting a planned pregnancy during the study period.
- History of bariatric surgery.
Show all 13Show fewer
- Report a current medical condition or treatment for a medical condition that could affect body weight.
- Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).
- Resting systolic blood pressure of 160 mmHg or more or resting diastolic blood pressure of 100 mmHg or more. If medicated for blood pressure control, the medication dose needs to be stable for at least 6 months.
- Eating disorders that would contraindicate weight loss or physical activity.
- Alcohol or substance abuse.
- Current psychological condition that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
MOVE for Health Study, 913-588-5882, jjakicic@kumc.edu
About this study
Official title: Effectiveness of the Addition of Yoga to a Behavioral Weight Loss Intervention for Adults With Overweight or Obesity (MOVE for Health)
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?
Read more
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.
- Conditions
- Obesity and Overweight
- Being tested
- Diet, Aerobic Exercise, Behavioral Sessions, Aerobic + Yoga Exercise
- Keywords
- obesity, overweight, exercise, physical activity, yoga, weight loss
- Medical subject headings
- Obesity, Overweight, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
A reduced energy diet ranging from 1200-2100 kilocalories per day will be recommended for participants.
Aerobic ExerciseBehavioural
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 SessionsBehavioural
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.
Aerobic + Yoga ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss Plus Aerobic Physical Activity | Experimental | 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. Receives: Behavioral: Diet; Behavioral: Aerobic Exercise; Behavioral: Behavioral Sessions |
| Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga | Experimental | 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. Receives: Behavioral: Diet; Behavioral: Behavioral Sessions; Behavioral: Aerobic + Yoga Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
Measured: 0, 3, 6, 9, 12 months
Secondary outcomes (26)
Body Mass Index
Measurements of weight and height will be used to compute BMI (kg/m2).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 0, 6, 12 months
Waist Circumference
Circumference measures of the waist taken horizontally at both the iliac crest and the umbilicus will be performed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between weeks 2-6, at 6 months, at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start3 Jan 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Jakicic, PhD, University of Kansas Medical Center
- Investigators
- John M. Jakicic, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636773
- Sponsor's protocol ID
- STUDY00160080
- Other IDs
- R01DK135735-01A1
- Status last verified
- Jan 2026
- First submitted
- 4 Oct 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Addition of Yoga to a Behavioral Weight Loss Intervention for Adults With Overweight or Obesity (MOVE for Health)
- ClinicalTrials.gov ID
- NCT06636773
- Acronym / sponsor ID
- STUDY00160080
- Conditions
- Obesity and Overweight
- Keywords
- obesity, overweight, exercise, physical activity, yoga, weight loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss Plus Aerobic Physical Activity | Experimental | Behavioral: Diet, Behavioral: Aerobic Exercise, Behavioral: Behavioral SessionsThe 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 Weight Loss Plus Aerobic Physical Activity and Yoga | Experimental | Behavioral: Diet, Behavioral: Behavioral Sessions, Behavioral: Aerobic + Yoga ExerciseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both males and females of all race/ethnic groups are eligible for participation in this study.
- at least 18 years of age. The investigators will not limit enrollment based on an upper age provided that the participant meets the other eligibility requirements.
- Body mass index (BMI) of at least 25.0 kg/m2. The investigators will not limit enrollment based on an upper BMI level provided that the participant meets the other eligibility requirements. However, maximal weight to be eligible will be 350 pounds to meet the weight requirements for the equipment that will be used in this study.
- Ability to provide informed consent prior to participation in this study.
- Ability to provide clearance from their primary care physician to engage in the diet and physical activity components of the weight loss intervention.
Key exclusion criteria (13 listed)
- Report moderate-to-vigorous exercise on \>3 days/week or a total of \>60 min/week over the past 3 months.
- Engaging in any style of yoga on an average of at least 1 day/week over the past 3 months.
- Report weight loss of 3% or more or participating in a weight reduction diet in the past 3 months.
- Currently prescribed an anti-obesity medication.
- Females who are pregnant or breastfeeding or reporting a planned pregnancy during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietA reduced energy diet ranging from 1200-2100 kilocalories per day will be recommended for participants. | Behavioural | Behavioral Weight Loss Plus Aerobic Physical Activity, Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga |
| Aerobic ExercisePhysical 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. | Behavioural | Behavioral Weight Loss Plus Aerobic Physical Activity |
| Behavioral SessionsParticipants 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. | Behavioural | Behavioral Weight Loss Plus Aerobic Physical Activity, Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga |
| Aerobic + Yoga ExercisePhysical 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. | Behavioural | Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga |
Primary outcome
Body Weight
Time frame: 0, 3, 6, 9, 12 months
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
26 secondary outcomes
Body Mass Index
Time frame: 0, 3, 6, 9, 12 months
Percent body fat
Time frame: 0, 6, 12 months
Body Fat Mass
Time frame: 0, 6, 12 months
Lean Body Mass
Time frame: 0, 6, 12 months
Bone mineral content
Time frame: 0, 6, 12 months
Waist Circumference
Time frame: 0, 6, 12 months
Cardiorespiratory Fitness
Time frame: 0, 6, 12 months
Cardiorespiratory Fitness
Time frame: 0, 6, 12 months
Cardiorespiratory Fitness
Time frame: 0, 6, 12 months
Energy Intake (Dietary Intake)
Time frame: 0, 3, 6, 9, 12 months
Dietary Cognitive Restraint
Time frame: 0, 3, 6, 9, 12 months
Dietary Disinhibition
Time frame: 0, 3, 6, 9, 12 months
Hunger
Time frame: 0, 3, 6, 9, 12 months
Weight Loss Strategies
Time frame: 0, 3, 6, 9, 12 months
Weight Loss Strategies
Time frame: 0, 3, 6, 9, 12 months
Mood/Affect
Time frame: 0, 3, 6, 9, 12 months
Perceived Stress
Time frame: 0, 3, 6, 9, 12 months
Depressive Symptoms
Time frame: 0, 3, 6, 9, 12 months
Mindfulness
Time frame: 0, 3, 6, 9, 12 months
Mindfulness Practice
Time frame: 0, 3, 6, 9, 12 months
Sleep
Time frame: 0, 3, 6, 9, 12 months
Acute Physical Activity Test - perceived distress
Time frame: Between weeks 2-6, at 6 months, at 12 months
Acute Physical Activity Test - Mood
Time frame: Between weeks 2-6, at 6 months, at 12 months
Acute Physical Activity Test - Sleepiness
Time frame: Between weeks 2-6, at 6 months, at 12 months
Acute Physical Activity Test - Hunger
Time frame: Between weeks 2-6, at 6 months, at 12 months
Acute Physical Activity Test - Cortisol
Time frame: Between weeks 2-6, at 6 months, at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John M. Jakicic, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Aerobic Exercise and Behavioral Sessions in people with Obesity and Overweight, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John M Jakicic, PhD (913-588-9078, jjakicic@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 0, 3, 6, 9, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.