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

NCT00901095 | Completed Phase 2 DMC

• 1 other identifier: 1R01HL094466
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 8

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.

Conditions

Asthma; Obesity

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire

  Baseline, 6- and 12-months

Secondary Outcomes (7)

• Lung function

  Baseline, 6-, and 12-months

• Quality of Life

  Baseline, 6- and 12-months

• Symptom-free days

  Baseline, 6- and 12-month

• Asthma-related and total health care utilization

  Baseline, 6- and 12-month

• BMI, diet, and physical activity

  Baseline, 6- and 12-months

Study Arms (2)

Control

NO INTERVENTION

Usual Care

Lifestyle intervention

EXPERIMENTAL

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.

Behavioral: Lifestyle intervention

Interventions

Lifestyle intervention BEHAVIORAL

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.

Also known as: In-person sessions and self-monitoring

Lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Palo Alto Medical Foundation: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Kaiser Permanente: collaborator
• Stanford University: collaborator

Study Sites (8)

Kaiser Permananete, Fremont Medical Center

Fremont, California, 94538, United States

Location

Kaiser Permananete, Hayward Medical Center

Hayward, California, 94545, United States

Location

Kaiser Permananete, Novato Medical Center

Novato, California, 94945, United States

Location

Kaiser Permanente

Oakland, California, 94611, United States

Location

Kaiser Permanente

Richmond, California, 94801, United States

Location

Kaiser Permanente, San Francisco Medical Center

San Francisco, California, 94115, United States

Location

Kaiser Permananete, San Jose Medical Center

San Jose, California, 95119, United States

Location

Kaiser Permanente

Santa Clara, California, 95051, United States

Location

Related Publications (3)

• 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.

  PMID: 28059466 DERIVED

• 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.

  PMID: 25496399 DERIVED

• 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.

  PMID: 20334686 DERIVED

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

Study Officials

• Jun Ma, M.D.,Ph.D.

  Palo Alto Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Investigator

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: February 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

US (8)