AzTrials
AzTrials

AsthmaNCT01725945

The DASH Diet for Adults With Uncontrolled Asthma

A study testing Dietary Approaches to Stop Hypertension dietary pattern in people with Asthma and Hypertension, run by Palo Alto Medical Foundation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Asthma, Hypertension
What is being tested?
Dietary Approaches to Stop Hypertension dietary pattern
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesUnited States
Study dates
Jan 2013to May 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Kaiser Permanente, Hayward Medical Center, Allergy Department

    Hayward, California, 94545

  • Kaiser Permanente, San Francisco Medical Center, Allergy Department

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Pilot Study of the DASH Diet in Not-Well-Controlled Adult Asthma

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.

Read the 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
Being tested
Dietary Approaches to Stop Hypertension dietary pattern
Keywords
DASH, diet, asthma, adults, asthma control
Medical subject headings
Asthma, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary Approaches to Stop Hypertension dietary patternBehavioural

    Also called DASH

    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.

Study groups in NCT01725945
Study groupRoleWhat they receive
Usual CareNo interventionUsual Care
DASH InterventionExperimentalDietary 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.
Receives: Behavioral: Dietary Approaches to Stop Hypertension dietary pattern

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6-months post-randomizaton

Secondary outcomes (8)

  1. Lung function

    Lung function measured by spirometry

    Measured: 6-months post-randomization

  2. Asthma specific Quality of Life

    Juniper Mini Asthma Quality of Life Questionnaire (Mini-AQLQ)

    Measured: 6-months post-randomization

  3. 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.

    Measured: 6-months post-randomization

  4. 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

    Measured: 6 months pre-and post-randomization

  5. 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.

    Measured: 6-months post-randomization

  6. Psychosocial predictors of dietary change

    Self-efficacy and social support for dietary change will be assessed using previously validated instruments.

    Measured: 6-months post-randomization

  7. 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.

    Measured: 6-months post-randomization

  8. 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.

    Measured: 6-months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01725945
Sponsor's protocol ID
R34HL108753
Other IDs
R34HL108753
Status last verified
Sep 2014
First submitted
7 Nov 2012
Last updated
18 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33871602

  • 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.

    PubMed 25343191

  • 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.

    PubMed 23648395

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Approaches to Stop Hypertension dietary pattern in people with Asthma and Hypertension, run by Palo Alto Medical Foundation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

7-item Juniper Asthma Control Questionnaire (ACQ) (time frame: 6-months post-randomizaton). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01725945, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in