physicAl aCtiviTy In minOrity womeN With Asthma Intervention

NCT03265665 | Completed Results

• 2 other identifiers: 2016-0466K01HL133370
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a 3lifestyle physical activity intervention refined to be applicable for sedentary African American (AA) women with asthma. The main outcome of this study is to test the feasibility, acceptability and estimate the efficacy of the ACTION intervention in a randomized controlled pilot of 80 AA women with asthma within a pragmatic community setting at 24-weeks.

Conditions

Asthma

Keywords

walking; African American women; lifestyle

Outcome Measures

Primary Outcomes (5)

• Feasibility of Intervention-Recruitment

  The total number of participants recruited and consented in the study.

  24 weeks

• Feasibility of Intervention-Withdrawals

  Number of participants that withdrew from the study

  24 weeks

• Feasibility of Lifestyle PA Intervention

  Number of participants that completed 24-week outcomes assessment

  24 weeks

• Acceptability of Lifestyle PA Intervention

  Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7.

  24-weeks

• Acceptability of Lifestyle PA Intervention-Qualitative Data

  Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data.

  24-weeks

Secondary Outcomes (6)

• Light Physical Activity Levels

  24 weeks

• Asthma Quality of Life Questionnaire (AQLQ)

  24 weeks

• Asthma Control Questionnaire (ACQ-6)

  24 weeks

• Daily Step Counts

  24 weeks

• Moderate Physical Activity Levels

  24 weeks

Study Arms (2)

ACTION Intervention

EXPERIMENTAL

Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.

Behavioral: ACTION Intervention

Enhanced usual care

OTHER

Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.

Other: Enhanced usual care

Interventions

ACTION Intervention BEHAVIORAL

The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.

Also known as: Group sessions

ACTION Intervention

Enhanced usual care OTHER

Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.

Enhanced usual care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: The focus population for this study is sedentary African-American (AA) women with asthma. All participants included in the study will self-identify themselves as female and AA. This study population was chosen as AA women are disproportionately impacted by physical inactivity and asthma compared to Caucasian men and women and AA men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identify as female and black or AA
• Age 18-70
• Sub-optimally controlled persistent asthma based on Asthma Control Test (ACT \<20)
• Wiling to enroll and provide written-informed consent
• Willing to be randomly assigned to treatment or control group

You may not qualify if:

• Unable to ambulate without human assistance (ie. use of a wheelchair, scooter)
• History of significant mental illness (e.g. uncontrolled bipolar disorder, psychoses)
• Currently pregnant, planning to become pregnant over the next 3 months
• Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (\>20 pack years)
• Poorly controlled high blood pressure (BP \>180/100 at baseline visit)
• Family/household member of another study participant or staff member
• Inability to speak, read or understand English;
• Investigator discretion for safety or protocol adherence reasons
• Participation in ACTION focus groups (Aim 1) or pre-pilot (Aim 2) of the study

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Sharmilee Nyenhuis
• Organization: University of Illinois at Chicago

snyenhui@uic.edu

3124131655

Study Officials

• Sharmilee M Nyenhuis, MD

  University of Illinois at Chicago

  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: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 29, 2017
• Study Start: October 1, 2017
• Primary Completion: June 15, 2019
• Study Completion: September 30, 2019
• Last Updated: February 23, 2022
• Results First Posted: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)