Asthma and Obesity: Pilot Study

NCT04113746 | Completed Results DMC

• 2 other identifiers: GCO 14-1859 IR01HL129198
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma; Obesity

Keywords

Asthma; Obesity; Self-management behaviors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Medication Adherence Rating Scale (MARS)

  At 30 days Post-pilot follow-up visit, up to 2 months

• Physical Activity - Step Counts Per Day

  Week 2, Week 4, and at 30 days Post-pilot follow-up visit

• Time in Physical Activity

  Week 2, Week 4, and at 30 days Post-pilot follow-up visit

• Asthma Control Questionnaire (ACQ)

  at 30 days Post-pilot follow-up visit, up to 2 months

• Asthma Quality of Life Questionnaire (AQLQ)

  at 30 days post-pilot follow-up visit, up to 2 months

Study Arms (2)

Asthma and Exercise Lifestyle Change

EXPERIMENTAL

Participants receive asthma and lifestyle change education related to exercise

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

Asthma Education

PLACEBO COMPARATOR

No lifestyle change education

Behavioral: Asthma Education

Interventions

Better asthma self-management and incorporation of physical activity BEHAVIORAL

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 and Exercise Lifestyle Change

Asthma Education BEHAVIORAL

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.

Asthma Education

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• University of Colorado, Denver: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Asthma; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Juan P. Wisnivesky, MD, DrPH
• Organization: Icahn School of Medicine at Mount Sinai

juan.wisnivesky@mountsinai.org

212-824-7567

Study Officials

• Juan P. Wisnivesky, MD, DrPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Alex D. Federman, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Fernando Holguin, MD, MPH

  University of Colorado Denver, Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Research Coordinator who is administering the follow-up survey will be masked
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: October 3, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Locations

US (2)