search
Back to results

The DASH Diet for Adults With Uncontrolled Asthma

Primary Purpose

Asthma, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Approaches to Stop Hypertension dietary pattern
Sponsored by
Palo Alto Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring DASH, diet, asthma, adults, asthma control

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente, Hayward Medical Center, Allergy Department
  • Kaiser Permanente, San Francisco Medical Center, Allergy Department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

DASH Intervention

Arm Description

Usual Care

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Lung function
Lung function measured by spirometry
Asthma specific Quality of Life
Juniper Mini Asthma Quality of Life Questionnaire (Mini-AQLQ)
Asthma symptom-free and β2-agonist-free days
Asthma symptom-free and β2-agonist-free days will be calculated from 2-week asthma symptom diaries.
Asthma-related health care utilization
Asthma-related health care utilization will be assessed through data extraction from Kaiser Permanente (KP) electronic databases for the periods of 6 months pre- and post-randomization
Diet adherence
Participants' adherence to the DASH diet will be assessed by multiple-pass 24-hour diet recalls for servings of fruits, vegetables, dairy products, and whole grains; increases in serum carotenoids, folate and vitamin B12; and reductions in fasting plasma lipids.
Psychosocial predictors of dietary change
Self-efficacy and social support for dietary change will be assessed using previously validated instruments.
Comorbidities
Sleep apnea and gastroesophageal reflux disease (GERD) are common comorbidities of obesity and asthma. The Berlin Questionnaire for Sleep Apnea and the GERD Symptom Assessment Scale will be administered to screen for these conditions and to assess changes in symptoms. In addition, the Pittsburgh Sleep Quality Index will be used to assess participants' usual sleep habits and sleep quality. The 9-item Patient Health Questionnaire (PHQ-9) is both a measure of depressive symptomatology and a tentative diagnostic instrument for the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) depressive disorders.
Generic health related Quality of Life
The 12-item Short Form Health Survey (SF-12) is a widely used measure to assess non-disease specific physical and mental health status.

Full Information

First Posted
November 7, 2012
Last Updated
September 17, 2014
Sponsor
Palo Alto Medical Foundation
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Kaiser Permanente, Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT01725945
Brief Title
The DASH Diet for Adults With Uncontrolled Asthma
Official Title
A Pilot Study of the DASH Diet in Not-Well-Controlled Adult Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Medical Foundation
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Kaiser Permanente, Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Hypertension
Keywords
DASH, diet, asthma, adults, asthma control

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Arm Title
DASH Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Approaches to Stop Hypertension dietary pattern
Other Intervention Name(s)
DASH
Intervention Description
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.
Primary Outcome Measure Information:
Title
7-item Juniper Asthma Control Questionnaire (ACQ)
Description
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.
Time Frame
6-months post-randomizaton
Secondary Outcome Measure Information:
Title
Lung function
Description
Lung function measured by spirometry
Time Frame
6-months post-randomization
Title
Asthma specific Quality of Life
Description
Juniper Mini Asthma Quality of Life Questionnaire (Mini-AQLQ)
Time Frame
6-months post-randomization
Title
Asthma symptom-free and β2-agonist-free days
Description
Asthma symptom-free and β2-agonist-free days will be calculated from 2-week asthma symptom diaries.
Time Frame
6-months post-randomization
Title
Asthma-related health care utilization
Description
Asthma-related health care utilization will be assessed through data extraction from Kaiser Permanente (KP) electronic databases for the periods of 6 months pre- and post-randomization
Time Frame
6 months pre-and post-randomization
Title
Diet adherence
Description
Participants' adherence to the DASH diet will be assessed by multiple-pass 24-hour diet recalls for servings of fruits, vegetables, dairy products, and whole grains; increases in serum carotenoids, folate and vitamin B12; and reductions in fasting plasma lipids.
Time Frame
6-months post-randomization
Title
Psychosocial predictors of dietary change
Description
Self-efficacy and social support for dietary change will be assessed using previously validated instruments.
Time Frame
6-months post-randomization
Title
Comorbidities
Description
Sleep apnea and gastroesophageal reflux disease (GERD) are common comorbidities of obesity and asthma. The Berlin Questionnaire for Sleep Apnea and the GERD Symptom Assessment Scale will be administered to screen for these conditions and to assess changes in symptoms. In addition, the Pittsburgh Sleep Quality Index will be used to assess participants' usual sleep habits and sleep quality. The 9-item Patient Health Questionnaire (PHQ-9) is both a measure of depressive symptomatology and a tentative diagnostic instrument for the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) depressive disorders.
Time Frame
6-months post-randomization
Title
Generic health related Quality of Life
Description
The 12-item Short Form Health Survey (SF-12) is a widely used measure to assess non-disease specific physical and mental health status.
Time Frame
6-months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ma, MD, PhD
Organizational Affiliation
Palo Alto Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente, Hayward Medical Center, Allergy Department
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Kaiser Permanente, San Francisco Medical Center, Allergy Department
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33871602
Citation
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.
Results Reference
derived
PubMed Identifier
25343191
Citation
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.
Results Reference
derived
PubMed Identifier
23648395
Citation
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.
Results Reference
derived

Learn more about this trial

The DASH Diet for Adults With Uncontrolled Asthma

We'll reach out to this number within 24 hrs