Asthma and Obesity: Pilot Study

Mount Sinai Health System

Status: Completed

Conditions: Asthma; Obesity

Treatments: Behavioral: Asthma Education; Behavioral: Better asthma self-management and incorporation of physical activity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04113746

R01HL129198 (U.S. NIH Grant/Contract)

GCO 14-1859 I

Details and patient eligibility

About

Develop and pilot test four theory-based educational modules that integrate counseling for asthma and obesity to promote greater physical activity among people with asthma.

Full description

Of the 400 obese and non-obese adult asthmatics in New York City and Denver during the 18-month observational phase of this study, the study team will randomize 80 participants (40 in NYC and 40 in Denver) into a 4-week group session pilot study focused on beliefs and behaviors associated with asthma and obesity self-management behaviors (SMB). Eligibility will be determined based on Asthma Control Questionnaire (ACQ) score and body mass index (BMI) at their 12-month visit. Participants will be randomized into an intervention or an active control arm after completing their 18-month visit. Participants will be consented into the pilot study during or after their 18-month visit. Participants will be put into groups of 7-10 for the pilot. Once formed, groups will have four 1-hour weekly visits. A person will be allowed to make up one missed session. The make-up session will be conducted on the phone or in-person depending on scheduling availability of both participant and care coach. Participants will be given accelerometers at sessions 1 and 4 that they will be asked to wear for seven days and return along with an activity diary. A follow-up survey will be administered about 30 days after the last pilot session in order to reassess the patient's asthma, obesity, exercise and medication beliefs and their adherence to asthma SMB. At the time of the follow-up survey, participants will also be given accelerometers that they will be asked to wear for seven days and return along with an activity diary.

Enrollment: 27 patients

Sex: All

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 21-64 years of age
• BMI ≥ 30
• Asthma diagnosis made by a health care provider
• Poor Asthma Control (ACQ score ≥ 0.75)
• English speaking

Exclusion criteria

• BMI < 30
• Good asthma control (ACQ score <0.75)
• Diagnosis of dementia
• Diagnosis of chronic obstructive pulmonary disease (COPD) or other chronic respiratory illness
• Smoking history of ≥15 pack-years owing to possible undiagnosed COPD

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups, including a placebo group

Asthma and Exercise Lifestyle Change

Experimental group

Description:

Participants receive asthma and lifestyle change education related to exercise

Treatment:

Behavioral: Better asthma self-management and incorporation of physical activity

Asthma Education

Placebo Comparator group

Description:

No lifestyle change education

Treatment:

Behavioral: Asthma Education