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Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
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.
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.
Age
21 - 64 years
Sex
ALL
Healthy Volunteers
No
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Start Date
October 3, 2019
Primary Completion Date
August 30, 2021
Completion Date
August 30, 2021
Last Updated
November 14, 2022
27
ACTUAL participants
Better asthma self-management and incorporation of physical activity
BEHAVIORAL
Asthma Education
BEHAVIORAL
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
NCT02327897
NCT07219173
NCT07472881
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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