NCT04113746

Asthma and Obesity: Pilot Study

Completed NA Results posted Last updated 14 November 2022

What this trial tests

NA trial testing Better asthma self-management and incorporation of physical activity in Asthma in 27 participants. Completed in 30 August 2021.

Timeline

3 October 2019

Primary endpoint
30 August 2021

30 August 2021

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	27
Start date	3 October 2019
Primary completion	30 August 2021
Estimated completion	30 August 2021
Sites	2 locations across United States

Drugs / interventions tested

• Better asthma self-management and incorporation of physical activity
• Asthma Education

Conditions studied

• Asthma — all drugs for Asthma →
• Obesity — all drugs for Obesity →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 21 to 64, any sex, with Asthma or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Beliefs About Illness Perception Questionnaire (BIPQ) Primary · At 30 days Post-pilot follow-up visit, up to 2 months

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.

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	42.6	± 11.4
Asthma Education	36.2	± 8.2

Medication Adherence Rating Scale (MARS) Secondary · At 30 days Post-pilot follow-up visit, up to 2 months

MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence.

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	4.7	± 0.5
Asthma Education	4.7	± 0.5

Physical Activity - Step Counts Per Day Secondary · Week 2, Week 4, and at 30 days Post-pilot follow-up visit

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

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	12253.3	± 0
Asthma Education	2499.7	± 1514.9

Week 4

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	13730.2	± 0
Asthma Education	2123.9	± 1751.0

at 30 days post pilot follow-up visit

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	2667.9	± 375.4
Asthma Education	3715.1	± 3041.5

Time in Physical Activity Secondary · Week 2, Week 4, and at 30 days Post-pilot follow-up visit

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

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	74.5	± 0
Asthma Education	8.6	± 7.0

Week 4

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	91.5	± 0
Asthma Education	10.3	± 8.3

at 30 days post pilot follow-up visit

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	9.9	± 6.8
Asthma Education	7.8	± 9.2

Asthma Control Questionnaire (ACQ) Secondary · at 30 days Post-pilot follow-up visit, up to 2 months

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.

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	1.6	± 1.0
Asthma Education	1.3	± 0.9

Asthma Quality of Life Questionnaire (AQLQ) Secondary · at 30 days post-pilot follow-up visit, up to 2 months

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.

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	4.9	± 0.8
Asthma Education	5.0	± 0.6

Beliefs About Medications Questionnaire (BMQ) - Necessity and Concerns Subscale Secondary · at 30 days post pilot follow-up visit, up to 2 months

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 -

Necessity Subscale

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	15	± 3.6
Asthma Education	16.4	± 5

Concerns Subscale

Group	Value	95% CI
Asthma and Exercise Lifestyle Change	8.4	± 1
Asthma Education	8.4	± 2.7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.