Clinical trial NCT04113746: Asthma and Obesity: Pilot Study
Official title: Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Obesity
Keywords: Asthma
Obesity
Self-management behaviors
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-10-03
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Beliefs About Illness Perception Questionnaire (BIPQ)
timeFrame: At 30 days Post-pilot follow-up visit, up to 2 months
Secondary outcomes:
measure: Medication Adherence Rating Scale (MARS)
timeFrame: At 30 days Post-pilot follow-up visit, up to 2 months
measure: Physical Activity - Step Counts Per Day
timeFrame: Week 2, Week 4, and at 30 days Post-pilot follow-up visit
measure: Time in Physical Activity
timeFrame: Week 2, Week 4, and at 30 days Post-pilot follow-up visit
measure: Asthma Control Questionnaire (ACQ)
timeFrame: at 30 days Post-pilot follow-up visit, up to 2 months
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: at 30 days post-pilot follow-up visit, up to 2 months
measure: Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale
timeFrame: at 30 days post pilot follow-up visit, up to 2 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Medical Campus
state: Colorado
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Juan P. Wisnivesky, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Alex D. Federman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Denver, Anschutz Medical Campus
name: Fernando Holguin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: