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. Author manuscript; available in PMC: 2014 Nov 3.
Published in final edited form as: Contemp Clin Trials. 2013 May 3;35(2):55–67. doi: 10.1016/j.cct.2013.04.008

Table 1.

Participant inclusion and exclusion criteria.

Inclusion criteria (patients will be included if meeting all of the following)
  • Ethnicity: All ethnic groups;

  • Gender: Both men and women;

  • Age (as of date of enrollment):
    • Lower age limit: 18 years; and
    • Upper age limit: 70 years;
  • Body mass index 18.5–39.9 kg/m2;

  • Suboptimally controlled asthma:
    • Documented history of high asthma-related emergency and/or inpatient encounters and/or high reliever medication usage: using relevant data in electronic health records, an enriched pool of potentially eligible patients who likely have uncontrolled, persistent asthma will be identified according to 1 or more of the following criteria:
      • at least 1 inpatient admission with a primary asthma diagnosis or a secondary asthma diagnosis accompanied by a primary asthma-related diagnosis during the past 12 months;
      • at least 1 emergency visit with an asthma diagnosis during the past 6 months;
      • at least 5 prescriptions for asthma medication filled during the past 6 months and at least 2 prescriptions for oral corticosteroids filled within the past 12 months;
      • at least 12 canisters of short-acting beta-agonists in the past 12 months;
      • at least 3 short-acting beta-agonist dispensing events during the past 12 months.
    • Physiological evidence of asthma with demonstrable reversibility of airway obstruction by spirometry, or a specialist's confirmation of asthma diagnosis based on chart review. As specified in our prior study [80], the airway obstruction reversibility criteria vary by individual depending upon smoking history and controller medication use and are as follows:
      • For smokers and nonsmokers who do not use controller medications regularly (≥4 days a week), reversibility is determined by an increase in FEV1 of ≥12% and ≥200 mL from baseline after inhalation of 4 puffs of albuterol.
      • For current or ex-smokers taking controller medications, reversibility is determined by an increase in FEV1 of ≥8% and ≥200 mL from baseline after inhalation of 4 puffs of albuterol.
      • No reversibility criteria apply to never smokers who regularly use controller medications.
    • Asthma Control Test: total score <20 or item score <3 for any of the first 4 questions regarding symptoms (3–6×/week or more), nighttime awakening (1×/week or more), interference with normal activity (at least some of the time), and rescue medication use for symptom relief (2–3×/week or more);
  • Kaiser member for ≥1 year;

  • PCP approval of study screening;

  • Able and willing to enroll and provide written informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to 1 of 2 treatment arms, participate in follow-up for 6 months, and authorize extraction of relevant information from their medical records.

Exclusion criteria (patients will be excluded if meeting any of the following)
Medical history exclusions
  • Primary diagnosis of intermittent asthma, defined as either seasonal asthma or (daytime asthma symptoms <2×/week and nocturnal symptoms <2×/month and no use of long-term control medications);

  • Primary diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis, spirometry, and smoking history;

  • Previous diabetes (other than during pregnancy) or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;

  • Previous cardiovascular disease: e.g., coronary heart disease (myocardial infarction, angina pectoris, percutaneous coronary intervention, coronary artery bypass graft surgery), cerebrovascular disease (stroke, transient ischemic attack), peripheral vascular disease, heart failure, or aortic aneurysm;

  • Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years;

  • Inflammatory bowel disease, colostomy, malabsorption, or major gastrointestinal resection;

  • Diagnosis of bipolar or psychotic disorder or hospitalization for psychological or emotional problems within the last 2 years;

  • Diagnosis of a terminal illness and/or in hospice care.

Medication exclusions
  • Current use of insulin or oral hypoglycemic agents;

  • Use of oral corticosteroids >5 days/month on average;

  • Current use of medications for treatment of psychosis or manic-depressive illness;

  • Current use of prescription or non-prescription weight-loss products or any dietary/herbal supplements and unwillingness to stop taking them for the duration of the study.

Other exclusions
  • Inability to speak, read, or understand English at the 6th-grade level or above;

  • Inability to perform pulmonary function tests by spirometry in a consistent manner;

  • DASH concordance indexa >60%;

  • Unwillingness to modify current diet;

  • Current/planned participation in another structured program that overtly focuses on diet and nutrition;

  • Planning to undergo bariatric surgery during the study period;

  • Actively attempting to lose weight or weight change >15 lbs during prior 3 months;

  • Consumption of >21 alcoholic drinks per week, or >=6 drinks on 1 occasion twice or more per week, or an alcohol abuse disorder as determined by the Alcohol Use Disorders Identification Test;

  • Currently pregnant, lactating, or planning to become pregnant during the study period;

  • No longer a Kaiser patient or planning to transfer care out of Kaiser or to move out of the area during the study period;

  • Family/household member of another study participant or of a study staff member;

  • Currently enrolled or planning to enroll in another research study that would limit full participation in the study or confound the interpretation of the study's findings;

  • Investigator discretion for clinical safety or protocol adherence reasons.

a

DASH concordance index is calculated based on combining nine nutrient targets (i.e., total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium, and potassium) [119121]. The intermediate target of each nutrient is half-way between the DASH target and population mean (based on the National Health and Nutrition Examination Surveys 2007–2008, most recent data available at the inception of this study). The table including the nine nutrient DASH targets, intermediate targets, and population means is included in the Appendix. For a nutrient, participants reaching the DASH target are assigned one point, those reaching the intermediate target are assigned a half-point, and those not meeting the intermediate target are given 0 point. The DASH concordance index is the sum of points for all nine nutrients.