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

S

Sutter Health

Status and phase

Completed
Phase 2

Conditions

Asthma
Obesity

Treatments

Behavioral: Lifestyle intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00901095
1R01HL094466

Details and patient eligibility

About

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.

Enrollment

330 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

330 participants in 2 patient groups

Control
No Intervention group
Description:
Usual Care
Lifestyle intervention
Experimental group
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.
Treatment:
Behavioral: Lifestyle intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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