The DASH Diet for Adults With Uncontrolled Asthma

NCT01725945 | Completed

• 1 other identifier: R34HL108753
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot study aims to provide effect size estimates and justification, clinical trial and intervention feasibility data, and procedural materials for a full-scale randomized controlled trial that will determine the efficacy and mechanisms of action of the Dietary Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled asthma.

Conditions

Asthma; Hypertension

Keywords

DASH; diet; asthma; adults; asthma control

Outcome Measures

Primary Outcomes (1)

• 7-item Juniper Asthma Control Questionnaire (ACQ)

  The ACQ provides a reliable, validated assessment of asthma control focusing on current impairment. Its 7 items assess the components of current asthma impairment as defined in the asthma treatment guidelines, i.e., daytime and nocturnal asthma symptoms, activity limitations, rescue medication use (excluding use to prevent exercise-induced bronchospasm), and lung function (FEV1). The ACQ is the only guideline-recommended composite measure of asthma control that includes lung function in its overall rating.

  6-months post-randomizaton

Secondary Outcomes (8)

• Lung function

  6-months post-randomization

• Asthma specific Quality of Life

  6-months post-randomization

• Asthma symptom-free and β2-agonist-free days

  6-months post-randomization

• Asthma-related health care utilization

  6 months pre-and post-randomization

• Diet adherence

  6-months post-randomization

Study Arms (2)

Usual Care

NO INTERVENTION

Usual Care

DASH Intervention

EXPERIMENTAL

Dietary Approaches to Stop Hypertension dietary pattern. Usual care in combination with a DASH intervention consisting of 8 group and 3 individual sessions over 3 months, followed by 3 monthly phone consultations.

Behavioral: Dietary Approaches to Stop Hypertension dietary pattern

Interventions

Dietary Approaches to Stop Hypertension dietary pattern BEHAVIORAL

The intervention will employ a series of small group and individual sessions, followed by periodic telephone contacts, to help participants make appropriate dietary changes and develop the skills to maintain these changes over the long term. The initial 3 months of intensive intervention will involve 8 group and 3 individual sessions for 45-60 minutes each. During the next 3 months, participants will receive counseling phone calls once per month for 20-30 minutes each call. Group session sizes may range from 8-15 participants.

Also known as: DASH

DASH 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:

• Ethnicity: All ethnic groups
• Body mass index (BMI) 18.5-39.9 kg/m2
• Suboptimally controlled asthma:
• Diagnosis of asthma on the current medical problem list
• Currently prescribed at least 1 medication for the treatment of asthma
• Physiological evidence of asthma with demonstrable reversibility of airway obstruction, or a specialist's confirmation of asthma diagnosis based on chart review
• Documented history of high asthma-related emergency and/or inpatient encounters or reliever medication usage
• Asthma Control Test: total score \<20 or item score \<3 for any of the first 4 questions regarding symptoms (3-6x/week or more), nighttime awakening (1x/week or more), interference with normal activity (at least some of the time), and rescue medication use for symptom relief (2-3x/week or more)
• Kaiser member for ≥1 year
• PCP approval of study screening
• Able and willing to enroll and provide written informed consent

You may not qualify if:

• 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)
• Primary diagnosis of COPD (emphysema or chronic bronchitis) on the current medical problem list or suggested by baseline 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 at screening
• Previous cardiovascular disease: e.g., coronary heart disease, cerebrovascular disease, 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
• Fasting LDL cholesterol \>190 mg/dL, triglycerides \>500 mg/dl, fasting blood glucose \>125 mg/dl
• Significant liver enzyme abnormality as indicated by AST or ALT more than 2 times the upper limit of normal or a clinical diagnosis of hepatitis
• Renal insufficiency (GFR\<60 ml/min)
• 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 discontinue;

Sponsors & Collaborators

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

Study Sites (2)

Kaiser Permanente, Hayward Medical Center, Allergy Department

Hayward, California, 94545, United States

Location

Kaiser Permanente, San Francisco Medical Center, Allergy Department

San Francisco, California, 94115, United States

Location

Related Publications (3)

• Nygaard UC, Xiao L, Nadeau KC, Hew KM, Lv N, Camargo CA, Strub P, Ma J. Improved diet quality is associated with decreased concentrations of inflammatory markers in adults with uncontrolled asthma. Am J Clin Nutr. 2021 Sep 1;114(3):1012-1027. doi: 10.1093/ajcn/nqab063.

  PMID: 33871602 DERIVED

• Lv N, Xiao L, Camargo CA Jr, Wilson SR, Buist AS, Strub P, Nadeau KC, Ma J. Abdominal and general adiposity and level of asthma control in adults with uncontrolled asthma. Ann Am Thorac Soc. 2014 Oct;11(8):1218-24. doi: 10.1513/AnnalsATS.201405-214OC.

  PMID: 25343191 DERIVED

• Ma J, Strub P, Lavori PW, Buist AS, Camargo CA Jr, Nadeau KC, Wilson SR, Xiao L. DASH for asthma: a pilot study of the DASH diet in not-well-controlled adult asthma. Contemp Clin Trials. 2013 Jul;35(2):55-67. doi: 10.1016/j.cct.2013.04.008. Epub 2013 May 3.

  PMID: 23648395 DERIVED

MeSH Terms

Conditions

Asthma; Hypertension

Condition Hierarchy (Ancestors)

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

Study Officials

• Jun Ma, MD, PhD

  Palo Alto Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: November 7, 2012
• First Posted: November 14, 2012
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

US (2)