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Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults?

Primary Purpose

Asthma, Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Palo Alto Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants will meet all of the following:

  • Age: 18-70 years of age;
  • Obesity: BMI >30.0 kg/m2;
  • Physician-diagnosed asthma that is poorly controlled:

    • Documented diagnosis of asthma on the current medical problem list
    • Currently prescribed an anti-asthma medication
    • Overall score <20 on the Asthma Control Test (ACT)64 or a score<3 on any of the first four ACT questions regarding symptoms, nighttime awakening, interference with normal activity, and SABA use for symptom relief
    • Demonstrable airway reversibility
  • Seen in primary care at Kaiser at least once in the preceding 24 months;
  • KPNC member for >1 year.

Exclusion Criteria:

Any of the following will exclude participants from the study:

  • Inability to speak, read or understand English;
  • Intermittent asthma, defined as either seasonal asthma or (daytime asthma symptoms < 2x/week and nocturnal symptoms < 2x/month and no use of long-term control medications);
  • Diagnosis of COPD (emphysema or chronic bronchitis) on the current medical problem list or suggested by spirometry at baseline;
  • Unwilling to attempt weight loss, including unwillingness to perform self-monitoring;
  • Body weight change (+/-) > 10 pounds or use of weight-loss medications in the preceding 3 months;
  • Inability to perform pulmonary function tests by spirometry in a consistent manner;
  • Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse;
  • Diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol;
  • Regular use of medications that can cause weight gain (e.g., oral corticosteroids, insulin, certain oral hypoglycemics, certain antidepressants, etc.);
  • Under treatment for cancer or another condition that may prevent completion of follow-up;
  • Diagnosis of a terminal illness and/or in hospice care;
  • Use of a pacemaker or other implanted medical devices;
  • Pregnant, planning to become pregnant, or lactating;
  • Actively enrolled in a care management program focused on weight loss at Kaiser or elsewhere;
  • Already enrolled or planning to enroll in a research study that would limit full participation in the study or confound the observation and interpretation of the study's findings;
  • Family household member already enrolled in the study;
  • No longer receiving primary care from Kaiser, or planning not to do so within the study period;
  • PCP determination that the study is inappropriate or unsafe for the patient;
  • Investigator discretion for clinical safety or protocol adherence reasons.

Sites / Locations

  • Kaiser Permananete, Fremont Medical Center
  • Kaiser Permananete, Hayward Medical Center
  • Kaiser Permananete, Novato Medical Center
  • Kaiser Permanente
  • Kaiser Permanente
  • Kaiser Permanente, San Francisco Medical Center
  • Kaiser Permananete, San Jose Medical Center
  • Kaiser Permanente

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Lifestyle intervention

Arm Description

Usual Care

The Lifestyle intervention group consists of in-person meetings co-led by an exercise specialist and dietician as well as follow-ups with an interventionist by phone.

Outcomes

Primary Outcome Measures

Asthma Control Questionnaire

Secondary Outcome Measures

Lung function
Quality of Life
Symptom-free days
Asthma-related and total health care utilization
BMI, diet, and physical activity
Adverse Events
Patient Satisfaction

Full Information

First Posted
May 12, 2009
Last Updated
March 17, 2014
Sponsor
Palo Alto Medical Foundation
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Kaiser Permanente, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00901095
Brief Title
Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults?
Official Title
Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Medical Foundation
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Kaiser Permanente, Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of the study is to investigate the efficacy of an evidence-based weight loss intervention, on a background of quality health care, on asthma control among obese adults. The intervention will employ a combination of recommended dietary and physical activity changes, and behavioral modification techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care
Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
The Lifestyle intervention group consists of in-person meetings co-led by an exercise specialist and dietician as well as follow-ups with an interventionist by phone.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Other Intervention Name(s)
In-person sessions and self-monitoring
Intervention Description
Participants will attend a 15 weekly class sessions during the first 4 months. Classes will be co-lead by a dietician and exercise specialist and will involve a private weigh-in, a group discussion, a presentation of a lifestyle topic, 30 minutes of supervised moderate physical activity, followed by action-planning and goal-setting. During the next 2 months, participants will meet with a dietician on an individual basis for a private weigh-in, personal discussion and problem solving, review of self-monitoring records, and action-planning. The last 6 months will consist of applying and maintaining what has been learned in previous class sessions. Self-monitoring records, questions and problems will be discussed with interventions at least once every 2 months or more frequently if needed.
Primary Outcome Measure Information:
Title
Asthma Control Questionnaire
Time Frame
Baseline, 6- and 12-months
Secondary Outcome Measure Information:
Title
Lung function
Time Frame
Baseline, 6-, and 12-months
Title
Quality of Life
Time Frame
Baseline, 6- and 12-months
Title
Symptom-free days
Time Frame
Baseline, 6- and 12-month
Title
Asthma-related and total health care utilization
Time Frame
Baseline, 6- and 12-month
Title
BMI, diet, and physical activity
Time Frame
Baseline, 6- and 12-months
Title
Adverse Events
Time Frame
6- and 12-months
Title
Patient Satisfaction
Time Frame
Baseline and 12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will meet all of the following: Age: 18-70 years of age; Obesity: BMI >30.0 kg/m2; Physician-diagnosed asthma that is poorly controlled: Documented diagnosis of asthma on the current medical problem list Currently prescribed an anti-asthma medication Overall score <20 on the Asthma Control Test (ACT)64 or a score<3 on any of the first four ACT questions regarding symptoms, nighttime awakening, interference with normal activity, and SABA use for symptom relief Demonstrable airway reversibility Seen in primary care at Kaiser at least once in the preceding 24 months; KPNC member for >1 year. Exclusion Criteria: Any of the following will exclude participants from the study: Inability to speak, read or understand English; Intermittent asthma, defined as either seasonal asthma or (daytime asthma symptoms < 2x/week and nocturnal symptoms < 2x/month and no use of long-term control medications); Diagnosis of COPD (emphysema or chronic bronchitis) on the current medical problem list or suggested by spirometry at baseline; Unwilling to attempt weight loss, including unwillingness to perform self-monitoring; Body weight change (+/-) > 10 pounds or use of weight-loss medications in the preceding 3 months; Inability to perform pulmonary function tests by spirometry in a consistent manner; Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse; Diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol; Regular use of medications that can cause weight gain (e.g., oral corticosteroids, insulin, certain oral hypoglycemics, certain antidepressants, etc.); Under treatment for cancer or another condition that may prevent completion of follow-up; Diagnosis of a terminal illness and/or in hospice care; Use of a pacemaker or other implanted medical devices; Pregnant, planning to become pregnant, or lactating; Actively enrolled in a care management program focused on weight loss at Kaiser or elsewhere; Already enrolled or planning to enroll in a research study that would limit full participation in the study or confound the observation and interpretation of the study's findings; Family household member already enrolled in the study; No longer receiving primary care from Kaiser, or planning not to do so within the study period; PCP determination that the study is inappropriate or unsafe for the patient; Investigator discretion for clinical safety or protocol adherence reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ma, M.D.,Ph.D.
Organizational Affiliation
Palo Alto Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permananete, Fremont Medical Center
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Kaiser Permananete, Hayward Medical Center
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Kaiser Permananete, Novato Medical Center
City
Novato
State/Province
California
ZIP/Postal Code
94945
Country
United States
Facility Name
Kaiser Permanente
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente
City
Richmond
State/Province
California
ZIP/Postal Code
94801
Country
United States
Facility Name
Kaiser Permanente, San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permananete, San Jose Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28059466
Citation
Xiao L, Lv N, Rosas LG, Au D, Ma J. Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials. Obesity (Silver Spring). 2017 Feb;25(2):363-369. doi: 10.1002/oby.21737. Epub 2017 Jan 6.
Results Reference
derived
PubMed Identifier
25496399
Citation
Ma J, Strub P, Xiao L, Lavori PW, Camargo CA Jr, Wilson SR, Gardner CD, Buist AS, Haskell WL, Lv N. Behavioral weight loss and physical activity intervention in obese adults with asthma. A randomized trial. Ann Am Thorac Soc. 2015 Jan;12(1):1-11. doi: 10.1513/AnnalsATS.201406-271OC.
Results Reference
derived
PubMed Identifier
20334686
Citation
Ma J, Strub P, Camargo CA Jr, Xiao L, Ayala E, Gardner CD, Buist AS, Haskell WL, Lavori PW, Wilson SR. The Breathe Easier through Weight Loss Lifestyle (BE WELL) Intervention: a randomized controlled trial. BMC Pulm Med. 2010 Mar 24;10:16. doi: 10.1186/1471-2466-10-16.
Results Reference
derived

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Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults?

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