The DASH Diet for Adults With Uncontrolled Asthma

NCT ID: NCT01725945

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-05-31

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.

Detailed Description

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. Eligible, consenting participants (n=90) will be randomized to receive usual care alone or combined with a DASH intervention. Follow-up assessments will occur at 3 and 6 months. By evaluating a dietary pattern approach to improving asthma control, this study could advance the evidence base for refining clinical guidelines and public health recommendations regarding the role of dietary modifications in asthma management.

Conditions

Asthma; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

DASH Intervention

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.

Group Type: EXPERIMENTAL

Dietary Approaches to Stop Hypertension dietary pattern

Intervention Type: 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.

Interventions

Dietary Approaches to Stop Hypertension dietary pattern

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

DASH

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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;
• 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 index >60%
• Unwillingness to modify current diet
• Current or planned participation in a 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 one occasion twice or more per week, or alcoholism as determined by the Alcohol Use Disorders Identification Test
• 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
• 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 safety or protocol adherence reasons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Palo Alto Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Jun Ma, MD, PhD

Associate Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Ma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Medical Foundation

Locations

Kaiser Permanente, Hayward Medical Center, Allergy Department

Hayward, California, United States

Kaiser Permanente, San Francisco Medical Center, Allergy Department

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33871602 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25343191 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23648395 (View on PubMed)

Other Identifiers

R34HL108753

Identifier Type: NIH

Identifier Source: secondary_id

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R34HL108753

Identifier Type: NIH

Identifier Source: org_study_id

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