Asthma and Obesity: Pilot Study

Obesity Clinical Trial

Official title:

Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113746
• Other study ID #: GCO 14-1859 I
• Secondary ID: R01HL129198
• Status: Completed
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: August 30, 2021

Study information

• Verified date: October 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Obesity

Intervention

Behavioral:
• Better asthma self-management and incorporation of physical activity
Participants in the asthma and exercise lifestyle change arm will participate in 4 sessions focused on behavioral change and goal-setting education to teach them how to better incorporate exercise into their daily lives and better manage their asthma. Following sessions 1 and 4, these participants will use the accelerometer to track activity, but will be blinded to the data.
• Asthma Education
General asthma education, but no discussion of the role of exercise and other lifestyle habits in asthma self-management. Following sessions 1 and 4, these participants will use the accelerometer to track activity, but will be blinded to the data.

Locations

Country	Name	City	State
United States	University of Colorado Denver, Anschutz Medical Campus	Aurora	Colorado
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beliefs About Illness Perception Questionnaire (BIPQ)	BIPQ includes 5 cognitive domains (Identity, Cause, Timeline, Consequences, and Cure-Control) designed to rapidly assess the cognitive and emotional representations of illness. Each item in each domain is scored on a 0 (none) to 10 (extreme). Full scale from 0-80, where higher score reflects a more threatening view of the illness.	At 30 days Post-pilot follow-up visit, up to 2 months
Secondary	Medication Adherence Rating Scale (MARS)	MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence.	At 30 days Post-pilot follow-up visit, up to 2 months
Secondary	Physical Activity - Step Counts Per Day	Physical activity monitoring using accelerometer and accompanying activity diary for self-report of wear. The accelerometer will measure step counts using previously determined cut-points. Based on accepted methodology, 3 or more out of the 7 days with 10 or more hours of wear time will be considered a valid measure of usual activity.	Week 2, Week 4, and at 30 days Post-pilot follow-up visit
Secondary	Time in Physical Activity	Physical activity monitoring using accelerometer and accompanying activity diary for self-report of wear. The accelerometer measured time spent in different intensities of activity using previously determined cut-points. Based on accepted methodology, 3 or more out of the 7 days with 10 or more hours of wear time was considered a valid measure of usual activity.	Week 2, Week 4, and at 30 days Post-pilot follow-up visit
Secondary	Asthma Control Questionnaire (ACQ)	Asthma Control Questionnaire (ACQ) - self-reported asthma control validated survey, with a total score range from 0-6, with a higher score indicating severely uncontrolled asthma, used to assess current asthma control at 30 days post-pilot follow up visit.	at 30 days Post-pilot follow-up visit, up to 2 months
Secondary	Asthma Quality of Life Questionnaire (AQLQ)	Asthma Quality of Life Questionnaire (AQLQ) - self-reported asthma-related quality of life validated survey used to assess asthma-related quality of life at 30 days post-pilot follow-up visit. Total Score from 1-7, with higher score indicating better quality of life.	at 30 days post-pilot follow-up visit, up to 2 months
Secondary	Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale	Beliefs about Medications Questionnaire (BMQ) - Necessity and Concerns; The BMQ comprises two separate two five-item sub-scales (Necessity and Concerns) and assesses respondents' beliefs about prescribed medicines that they are currently using for specific conditions, for e.g. asthma.; It assesses patients' beliefs about the necessity of prescribed medication for controlling their disease and their concerns about potential adverse consequences of taking it. Respondents indicate their degree of agreement with each statement on a five-point Likert scale, ranging from 1 - strongly disagree to 5 - strongly agree. Each subscale is scored from 5 -25. Scores obtained for individual items within both scales are summed. Thus, total scores for the Necessity and Concerns Scales range from 10-50. Higher scores indicate stronger beliefs in necessity or more concerns.	at 30 days post pilot follow-up visit, up to 2 months