The DASH Diet for Adults With Uncontrolled Asthma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01725945|
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : September 18, 2014
|Condition or disease||Intervention/treatment|
|Asthma Hypertension||Behavioral: Dietary Approaches to Stop Hypertension dietary pattern|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||A Pilot Study of the DASH Diet in Not-Well-Controlled Adult Asthma|
|Study Start Date :||January 2013|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2014|
No Intervention: Usual Care
Experimental: 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.
Behavioral: 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.
Other Name: DASH
- 7-item Juniper Asthma Control Questionnaire (ACQ) [ Time Frame: 6-months post-randomizaton ]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.
- Lung function [ Time Frame: 6-months post-randomization ]Lung function measured by spirometry
- Asthma specific Quality of Life [ Time Frame: 6-months post-randomization ]Juniper Mini Asthma Quality of Life Questionnaire (Mini-AQLQ)
- Asthma symptom-free and β2-agonist-free days [ Time Frame: 6-months post-randomization ]Asthma symptom-free and β2-agonist-free days will be calculated from 2-week asthma symptom diaries.
- Asthma-related health care utilization [ Time Frame: 6 months pre-and post-randomization ]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 [ Time Frame: 6-months post-randomization ]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 [ Time Frame: 6-months post-randomization ]Self-efficacy and social support for dietary change will be assessed using previously validated instruments.
- Comorbidities [ Time Frame: 6-months post-randomization ]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 [ Time Frame: 6-months post-randomization ]The 12-item Short Form Health Survey (SF-12) is a widely used measure to assess non-disease specific physical and mental health status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725945
|United States, California|
|Kaiser Permanente, Hayward Medical Center, Allergy Department|
|Hayward, California, United States, 94545|
|Kaiser Permanente, San Francisco Medical Center, Allergy Department|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Jun Ma, MD, PhD||Palo Alto Medical Foundation|