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Behavioural Intervention

Aerobic vs. Aerobic + Yoga Exercise for Obesity

N/A

Recruiting

Led By John M. Jakicic, PhD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have a Body Mass Index (BMI) of at least 25.0 kg/m2, with a maximal weight limit of 350 pounds.

Participants must be at least 18 years of age.

Must not have

Females who are pregnant or breastfeeding or reporting a planned pregnancy during the study period.

History of bariatric surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 3, 6, 9, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if adding yoga to a weight loss program helps adults who are overweight or obese lose weight more effectively. It also seeks to understand if this approach improves other health and fitness measures.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated in the provided information about this clinical trial on exercise for weight loss in adults with overweight or obesity issues typically do not have severe side effects; however participants may experience muscle soreness or fatigue from increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is at least 25 and I weigh no more than 350 pounds.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have had weight loss surgery in the past.

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I am currently taking medication for weight loss.

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I do not have heart failure, uncontrolled heart rhythm problems, or recent serious heart issues.

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I have not been hospitalized for mental health issues in the past year and have been on a stable mental health treatment for over 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 3, 6, 9, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 3, 6, 9, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3, 6, 9, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight

Secondary study objectives

Acute Physical Activity Test - Cortisol

Acute Physical Activity Test - Hunger

Acute Physical Activity Test - Mood

+20 more

Other study objectives

Adverse and Serious Adverse Events

Lifestyle and Health History

Medication History

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Behavioral Weight Loss Plus Aerobic Physical Activity and YogaExperimental Treatment3 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 ActivityExperimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic Exercise

2013

Completed Early Phase 1

~1350

Diet

2000

Completed Phase 4

~15070