Bridging Resources Improve the Development of Guideline-based Exercise

NCT03678974 | Completed

• 1 other identifier: 18-906
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to more effectively deliver the current standard of care for obesity and physical activity based on current guidelines. The investigators plan to gather preliminary data on physician-directed Intensive Behavioral Therapy for Obesity (IBT-O) utilizing CardioCoachCO2 by KORR technology to measure oxygen consumption both at rest and during exercise to assess resting metabolic rate (RMR) and cardiorespiratory fitness (CRF) respectively. RMR and CRF will be incorporated into an exercise prescription through implementation of the CardioCoach VO2 Max App as part of a multi-level physical activity intervention to improve CRF and decrease obesity by acting on multiple levels of the socio-ecological model in a primary care setting.

Conditions

Obesity; Physical Activity

Keywords

Cardiorespiratory Fitness; Intensive Behavioral Therapy for Obesity; Exercise Prescription

Outcome Measures

Primary Outcomes (1)

• Changes in Cardiorespiratory Fitness

  To evaluate whether exercise feedback will effect subjects' Cardiorespiratory Fitness through implementation of a proposed model of Intensive Behavioral Therapy for Obesity utilizing CardioCoachCO2, CardioCoach VO2 Max app, and H10 HR sensors to provide exercise feedback through comparison of VO2Max and VO2Peak to age and sex match norms. Statistical analysis will be performed on VO2Max,VO2Peak, and maximal MET level obtained during a graded exercise test, from baseline and following 6 months of exercise conditioning to determine if a statistically significant or clinically significant change (improvement of 1 MET) which has demonstrated a 12% decrease in all cause morality.

  6 Months

Secondary Outcomes (1)

• Changes in BMI

  6 Months

Study Arms (1)

Exercise

EXPERIMENTAL

Subjects will receive metabolic testing, exercise prescription, YMCA memberships, and physician based on Intensive Behavioral Therapy for Obesity utilizing CardioCoach app.

Behavioral: Exercise Prescription

Interventions

Exercise Prescription BEHAVIORAL

The CardioCoach Vo2Max app allows the physician to upload an individual's Vo2 Max and resting metabolic rate results to the app which will allow each subject to view those results in the context of workout zones, goals, and energy balance. The app shows time spent aerobic versus anaerobic, and the actual number of calories burned during a workout and post-workout. It will also show what fuel source (Fats vs Carbs) are being used in real time during your workouts. Subjects can be guided through their workouts utilizing voice coaching to keep you in your customized zones. Additionally, the app accommodates a quick add of calories directly to the app to track calories consumed vs calories burned.

Exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 years or older
• Obese (BMI ≥30 kg/m2), after taking into account age, gender, ethnicity, fluid status, and muscularity
• Stage of Change Readiness.(Preparation, Action, or Maintenance)
• Pre-participation Screening based on the ASCM 2015 guidelines
• Own a functioning Smart phone compatible with CardioCoach VO2 Max app

You may not qualify if:

• Any long-term disease that would interfere with their ability to exercise safely for eg Stroke with extremity weakness
• Pregnancy
• Musculoskeletal disorder that prohibits exercise

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Brentwood Foundation: collaborator

Study Sites (1)

ClevelandCF South Pointe Hospital

Warrensville Heights, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Debasis Sahoo, MD

  Attending Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 20, 2018
• Study Start: December 5, 2018
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

US (1)