Back to resultsAddressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern (ALOHA)
Primary Purpose
Asthma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Group A - Patient Education
Group B - Patient Education with Nutrition Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older at study enrollment
- Diagnosis of asthma with currently prescribed controller therapy (i.e., Step 2 or above) according to the 2020 asthma guideline update (EPR4)
- Uncontrolled asthma on study screening based on Asthma Control Test (ACT) scores <20
- Being able and willing to provide written informed consent and HIPAA authorization
Exclusion Criteria:
- Inability to speak, read or understand English sufficiently to provide valid informed consent
- Primary diagnosis of COPD (emphysema or chronic bronchitis)
- Previous cardiovascular disease: coronary heart disease (myocardial infarction, angina pectoris, percutaneous coronary intervention, coronary artery bypass graft surgery), cerebrovascular disease (stroke, transient ischemic attack), peripheral vascular disease, heart failure, or aortic aneurysm
- Diabetes (other than during pregnancy)
- Diagnosis of cancer (other than non-melanoma skin cancer) within the past year and/or actively receiving cancer treatment
- Inflammatory bowel disease, colostomy, malabsorption, or major gastrointestinal resection
- Diagnosis of bipolar or psychotic disorder
- Hospitalization for psychological or emotional problems within the last 2 years
- Cognitive impairment based on the Callahan 6-item screener67
- Terminal illness or in hospice or long-term care
- Current diet of good quality (DASH concordance index ≥6 out of 9 total)
- Current/planned participation in another structured program that overtly focuses on diet and nutrition
- On special diet that precludes changes adherent to the DASH dietary pattern or otherwise unwillingness to modify current diet
- Current use of prescription or non-prescription weight-loss products and unwillingness to stop taking them for the duration of the study
- Underweight per body mass index (BMI) below 18.5 kg/m2 based on measured height and weight at study enrollment
- Actively attempting to lose weight or weight change >15 lbs during prior 3 months
- Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)68
- Current within the past 6-months or former smoker (more than 20-packs of cigarettes in the lifetime, or current smoker)
- Current or planned pregnancy or currently lactating
- Planning to move out of the area during the study period
- Participation in another clinical trial or investigational treatment study
- Family/household member of an already enrolled participant or of a study team member
- Investigator discretion for clinical safety or protocol adherence reasons
Sites / Locations
- Department of MedicineRecruiting
- UIC CCTS Clinical Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A - Patinet Education
Group B - Patient Education with Nutrition Counseling
Arm Description
If you are assigned to this group, you will receive education on asthma and health from an ALOHA health coach.
If you are assigned to this group, you will receive the same patient education on asthma and health as Group A. In addition, you will receive nutrition counseling from your health coach who is a registered dietitian.
Outcomes
Primary Outcome Measures
Proportion of participants achieving a clinically significant improvement (responders) in asthma-specific quality of life (Aim 1)
The 15-item Juniper Mini Asthma-Specific Quality of Life Questionnaire (AQLQ) has been shown to have excellent reliability and responsiveness to change in asthma control. It consists of 5 items on symptoms, 4 items on activity limitations, 3 items on emotional function, and 3 items concerning environmental stimuli. Each item is rated on a scale from 1=maximum impairment to 7=no impairment over the last 2 weeks. The overall AQLQ score is an average of the item scores equally weighted. The primary outcome is the percentage of participants achieving the minimal clinically important difference (MCID) of at least a 0.5-point increase in AQLQ scores from baseline to 12 months. The percentages of responders at 3 and 6 months are secondary outcomes.
Secondary Outcome Measures
Level of asthma-specific quality of life (Aim 1)
The overall AQLQ score is the mean of all the items on the Mini AQLQ. Items are equally weighted. A domain score is calculated as the mean of all the items within each of the 4 domains: symptoms, activity limitations, emotional function, and environmental stimuli. Changes in overall and domain scores from baseline to each follow-up time point are secondary outcomes.
Level of asthma control (Aim 1)
The overall ACQ score is an average of the item scores equally weighted and ranges from 0=well controlled to 6=extremely poorly controlled. Change in ACQ scores from baseline to each follow-up time point are secondary outcomes.
Proportion of participants achieving a clinically significant improvement (responders) in asthma control (Aim 1)
The Juniper Asthma Control Questionnaire (ACQ) is a validated composite measure of asthma control recommended for research purposes. It consists of 7 items on daytime and nocturnal symptoms, activity limitations, rescue medication use (excluding prophylactic use for exercise-induced bronchospasm), and FEV1% of predicted norm. Each item is rated on a 7-point scale from 0 (least severe) to 6 (most severe). ACQ has been validated for self-administration (except for the FEV1 item, which is obtained by spirometry) and has high internal reliability (intra-class correlation coefficient=0.90). The overall ACQ score is an average of the item scores equally weighted. The proportion of responders is the percentage of participants achieving the MCID of at least a 0.5-point increase in ACQ scores. Percentages at each follow-up time point are secondary outcomes.
Level of Pre-bronchodilator measurements of FEV1 (Aim 1)
Lung function will be assessed by forced spirometry as per the American Thoracic Society (ATS) standards, both before and after bronchodilator. Post-bronchodilator spirometry will be performed at 15 minutes and 2 hours after bronchodilator administration. Participants will be instructed to refrain from taking inhaled medications for breathing during the 6-24 hours prior to their visit depending on the medication, unless they are having trouble with their breathing. Participants will blow forcefully for at least 6 seconds for 3-8 times until 3 acceptable results show repeatability. Spirometry outcomes for Aim 1 include PRE-bronchodilator measurements of forced expiratory volume in 1 second (FEV1)
Level of Pre-bronchodilator measurement of FVC (Aim 1)
Lung function will be assessed by forced spirometry as per the American Thoracic Society (ATS) standards, both before and after bronchodilator. Post-bronchodilator spirometry will be performed at 15 minutes and 2 hours after bronchodilator administration. Participants will be instructed to refrain from taking inhaled medications for breathing during the 6-24 hours prior to their visit depending on the medication, unless they are having trouble with their breathing. Participants will blow forcefully for at least 6 seconds for 3-8 times until 3 acceptable results show repeatability. Spirometry outcomes for Aim 1 include PRE-bronchodilator measurements of forced vial capacity (FVC).
Level of Pre-bronchodilator measurements FEV1/FVC (Aim 1)
Lung function will be assessed by forced spirometry as per the American Thoracic Society (ATS) standards, both before and after bronchodilator. Post-bronchodilator spirometry will be performed at 15 minutes and 2 hours after bronchodilator administration. Participants will be instructed to refrain from taking inhaled medications for breathing during the 6-24 hours prior to their visit depending on the medication, unless they are having trouble with their breathing. Participants will blow forcefully for at least 6 seconds for 3-8 times until 3 acceptable results show repeatability. Spirometry outcomes for Aim 1 include PRE-bronchodilator measurements of FEV1/FVC.
Level of asthma medication adherence (Aim 1)
The Adult Asthma Adherence Questionnaire is a validated and practical questionnaire that reflects nonadherence risk and identifies potential adherence barriers.
Count of episodes of poorly controlled asthma (Aim 1)
Episodes of poorly controlled asthma will be assessed as per a modified ALA-ACRC definition if any of the following apply: (1) addition of oral corticosteroid (prednisone or prednisolone) to treat asthma symptoms or (2) unscheduled contact with a health care provider (ED visit, physician office, hospital) for asthma symptoms.
Measure overall health-related quality of life
The 12-item Short-Form Health Survey (SF-12) is a 12-item version of the SF-36 that measures overall health-related quality of life. Physical and mental health composite scores are computed using the scores of 12 questions and range from 0 to 100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. Test-retest correlation is 0.89 for the physical health subscale and 0.76 for the mental health subscale.
Level of Blood pressure (BP) (Aim 1)
The American Heart Association recommendations for BP measurement will be followed. Participants will be told not to engage in vigorous exercise, ingest food or caffeine, or smoke within a half hour of BP measurements. If a half hour has not elapsed, the BP measurements must be delayed until a half hour has passed. BP will be measured in the seated position after at least a 5-minute rest in a quiet room where no other activity is taking place and where temperature fluctuations are minimal. At baseline, both arms will be measured once and 2 more times on the arm with higher systolic reading using standard equipment at participating clinics. This same arm will be measured 3 times at each follow-up assessment. Wait 1 minute between each measurement.
Level of psychological distress (Aim 1)
The Depression, Anxiety and Stress Scale-21 items (DASS21) is a set of 3 self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the 3 scales contains 7 items. Each item is scaled from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Each scale is scored as the sum of the item scores.
Level of sleep disturbance (Aim 1)
Sleep quality will be assessed on the 8-item PROMIS sleep disturbance (SD) scale. It measures symptoms of insomnia. Each item is scaled from 1 (not at all) to 5 (very much).
Level of sleep-related impairment (Aim 1)
The 8-item PROMIS sleep-related impairment (SRI) scale measures symptoms of daytime sleepiness. Each item is scaled from 1 (not at all) to 5 (very much). Correlation between the SD short form and the Pittsburgh Sleep Quality Index (PSQI, hypothesized to measure similar attributes) is 0.83 and correlation between the SRI short form and the Epworth Sleepiness Scale (ESS, hypothesized to measure a related but slightly different construct, the propensity to doze during activities) is 0.46, similar to the correlations between the SD full banks and PSQI (0.85) and between SRI full banks and the ESS (0.45).
Degree of bronchodilator responsiveness based on pre- and post-bronchodilator percent change in FEV1 (Aim 2)
Bronchodilator responsiveness will be measured based on percent change in FEV1 from prebronchodilator to 15 minutes and 2 hours postbronchodilator. Forced spirometry will be performed as per the American Thoracic Society (ATS) standards both before and after bronchodilator. Post-bronchodilator spirometry will be performed at 15 minutes and 2 hours after bronchodilator administration. Participants will be instructed to refrain from taking inhaled medications for breathing during the 6-24 hours prior to their visit depending on the medication, unless they are having trouble with their breathing. Participants will blow forcefully for at least 6 seconds for 3-8 times until 3 acceptable results show repeatability.
Level of plasma short chain fatty acids (propionate, butyrate, and acetate) (Aim 2)
Circulating short chain fatty acids (SCFA) will be measured with approximately 4 cc serum, aliquoted into 200 µl cryovials and kept frozen at -80°C. These samples will be shipped overnight on dry ice to the University of Michigan metabolomic core for measurement of propionate, butyrate and acetate, as circulating measures of products of gut microbial fermentation.
Level of PBMC cytokines (Interferon-γ, IL-5, IL-17A, IL-10, IL-1β, IL-6, IL-8, TNFα) (Aim 2)
To measure changes in adaptive and innate immune function pertinent to obese asthma, we will use the Tru-Culture® (myriad RBM tubes, 1 cc blood for each tube): one containing TruCulture® media + 0.1 μg/mL lipopolysaccharide, one containing TruCulture® media + 0.4 μg/mL anti-CD3, and one containing TruCulture® media alone. Samples will be incubated upright in a dry heat block at 37°C for 24 hours. Supernatant and cells will be isolated and frozen at -80°C, then shipped overnight on dry ice to the University of Vermont for cytokine and gene expression studies, respectively. For effects on T cell function pertinent to adaptive immunity we will measure cytokines pertinent to TH1 (interferon gamma), TH2 (IL-5), TH17 (IL-17A) and Tregs (IL-10) in media from cells incubated with anti-CD3 versus media alone. For effects on mononuclear cell responses pertinent to innate immunity, we will measure IL-1β, IL-6, IL-8 and TNFα in response to lipopolysaccharide versus media.
Level of diet quality based DASH score (Aim 3)
Dietary intake will be determined from 3 unannounced 24-hour dietary recalls (2 non-consecutive weekdays and 1 weekend day with a 2-week period) by interview using the US Department of Agriculture multiple pass method. The Nutrition Data System for Research (NDSR) (Minneapolis, MN) will be used for data collection and nutrient analysis. The DASH score using the National Health and Nutrition Survey (NHANES) method sums an individual's adherence points for 9 nutrients (total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium) based on the DASH diet plan. NDSR outputs will provide the values of these 9 nutrients.
Level of diet quality based on the dietary inflammatory index (DII) (Aim 3)
The DII will be applied to dietary intake data collected using the 3 unannounced 24-hour dietary recalls. The DII is a scale developed using data from epidemiologic, animal and in-vitro studies and is a useful marker of diet quality as it quantifies the overall inflammatory potential of diet, which is calculated based on the known inflammatory effects of up to 45 component nutrients and foods.
Level of plasma carotenoids (Aim 3)
4mL blood will be collected in an EDTA tube, centrifuged at 4oC, for 10 minutes at 3000g. Plasma will be stored at -80oC until analysis. High-performance liquid chromatography (HPLC) will be used to measure plasma carotenoid concentrations (lycopene, lutein, β-cryptoxanthin, α-carotene and β-carotene), as an objective indicator of fruit and vegetable intake. Carotenoids will be extracted from plasma samples (with canthaxanthin added as an internal standard) with a series of ethyl acetate and hexane washes. Chromatography will be performed on a Hypersil ODS column with a flow rate of 0.3 mL/min, using mobile phase of acetonitrile:dichloromethane:methanol (0.05% ammonium acetate (85:10:5, vol:vol)). Carotenoids will be detected at 470 nm using a photodiode array detector.
Full Information
NCT ID
NCT05251402
First Posted
February 2, 2022
Last Updated
June 15, 2023
Sponsor
University of Illinois at Chicago
Collaborators
Stanford University, University of Vermont, University of Newcastle, Australia, National Heart, Lung, and Blood Institute (NHLBI), University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT05251402
Brief Title
Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern
Acronym
ALOHA
Official Title
The ALOHA Trial: Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Stanford University, University of Vermont, University of Newcastle, Australia, National Heart, Lung, and Blood Institute (NHLBI), University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of the ALOHA trial is to investigate the efficacy of improved diet quality following a DASH behavioral intervention that has shown promising results in adults with uncontrolled asthma. DASH stands for Dietary Approaches to Stop Hypertension. This healthy diet is known to help people with high blood pressure manage their health. But physicians do not know if the DASH diet can also benefit patients with uncontrolled asthma. Researchers in the ALOHA study are trying to find out the answer to this important question.
Researchers at UIC are studying how 2 asthma care programs compare in terms of helping adults with uncontrolled asthma to improve their quality of life. Researchers also want to learn what might explain the differences in patient outcomes that they may see between the 2 programs.
The primary outcome will be asthma-specific quality of life. If the DASH behavioral intervention is found to benefit people with uncontrolled asthma, it would provide a practical, safe, and acceptable public-health intervention in the form of dietary modification to reduce the burden of asthma.
Detailed Description
Approximately 320 subjects who are determined fully eligible will be randomly assigned (by chance, like flipping a coin) to participate in intervention Group A or Group B, where you will receive either 1 of the 2 asthma care programs
Both asthma care programs are for a year and offer patient education on asthma and health. In both asthma care programs, you will receive fact-based patient information on asthma and health. Additionally, in one of the programs, a registered dietitian will also provide nutrition counseling on how to follow the USDA recommended DASH diet. Both asthma care programs offer 3 individual sessions, 8 group sessions, and 11 phone consultations. Your first individual session will be in-person with a trained health coach on the ALOHA team. The remaining 2 individual sessions will be either in-person or remote, depending on what you and your coach decide. You will also attend the first 2 (of 8) group sessions in-person to build connection with your coach and peer participants in the group. You and your coach will then decide whether you should attend the remaining group sessions in-person or remotely. Your ALOHA health coach will offer you continued support by phone until you complete your 1-year program.
Study Visits at UIC: Irrespective of your asthma care group, all participants will be expected to visit UIC Study site 4 times over the next year, initially and then at 3 months, at 6 months, and finally at one year. You will meet with an ALOHA study coordinator for 2 hours at the initial and final visits and for 1 hour at 3 and 6 months. Before each visit, you will complete online surveys about your health and phone interviews about your diet. At each visit, you will complete a breathing test, a blood draw, a physical exam, and questions about your asthma, diet and exercise habits, use of asthma medications and dietary supplements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A - Patinet Education
Arm Type
Active Comparator
Arm Description
If you are assigned to this group, you will receive education on asthma and health from an ALOHA health coach.
Arm Title
Group B - Patient Education with Nutrition Counseling
Arm Type
Active Comparator
Arm Description
If you are assigned to this group, you will receive the same patient education on asthma and health as Group A. In addition, you will receive nutrition counseling from your health coach who is a registered dietitian.
Intervention Type
Behavioral
Intervention Name(s)
Group A - Patient Education
Intervention Description
If you are assigned to this group, you will receive education on asthma and health from an ALOHA health coach.
In months 1-3, you will attend 3 individual and 8 group sessions. Individual sessions will last ~15 minutes and the first one will be in-person. Group sessions will last ~30 minutes and the first 2 of the 8 will be in person. You and your coach will determine if you may attend the remaining individual and group sessions remotely instead, via Zoom or phone. The purpose of these sessions is to provide you with general information about respiratory health topics, including recommendations for asthma care, inhaler use, and lung health.
In months 4-12, you will complete 11 phone check-ins for ~10 minutes each. The purpose of these phone calls is to provide you with ongoing support and discuss health topics of your choice.
Intervention Type
Behavioral
Intervention Name(s)
Group B - Patient Education with Nutrition Counseling
Intervention Description
If you are assigned to this group, you will receive the same patient education as Group A. In addition, you will receive nutrition counseling from your health coach who is a registered dietitian.
In months 1-3, the duration of the sessions will increase to ~30 minutes each for the 3 individual sessions and to ~60 minutes each for the 8 group sessions. This is because in addition to providing the same information on asthma and health as in Group A, your health coach will also counsel you on how to follow the DASH diet by adopting effective behavior change techniques such as goal setting, self-monitoring, and problem solving.
In months 4-12, your health coach will review your progress, provide you with personalized feedback, assist you in problem solving as you continue to work towards the DASH dietary goals, and help you maintain the changes you have made over the long term.
Primary Outcome Measure Information:
Title
Proportion of participants achieving a clinically significant improvement (responders) in asthma-specific quality of life (Aim 1)
Description
The 15-item Juniper Mini Asthma-Specific Quality of Life Questionnaire (AQLQ) has been shown to have excellent reliability and responsiveness to change in asthma control. It consists of 5 items on symptoms, 4 items on activity limitations, 3 items on emotional function, and 3 items concerning environmental stimuli. Each item is rated on a scale from 1=maximum impairment to 7=no impairment over the last 2 weeks. The overall AQLQ score is an average of the item scores equally weighted. The primary outcome is the percentage of participants achieving the minimal clinically important difference (MCID) of at least a 0.5-point increase in AQLQ scores from baseline to 12 months. The percentages of responders at 3 and 6 months are secondary outcomes.
Time Frame
Baseline, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Level of asthma-specific quality of life (Aim 1)
Description
The overall AQLQ score is the mean of all the items on the Mini AQLQ. Items are equally weighted. A domain score is calculated as the mean of all the items within each of the 4 domains: symptoms, activity limitations, emotional function, and environmental stimuli. Changes in overall and domain scores from baseline to each follow-up time point are secondary outcomes.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of asthma control (Aim 1)
Description
The overall ACQ score is an average of the item scores equally weighted and ranges from 0=well controlled to 6=extremely poorly controlled. Change in ACQ scores from baseline to each follow-up time point are secondary outcomes.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Proportion of participants achieving a clinically significant improvement (responders) in asthma control (Aim 1)
Description
The Juniper Asthma Control Questionnaire (ACQ) is a validated composite measure of asthma control recommended for research purposes. It consists of 7 items on daytime and nocturnal symptoms, activity limitations, rescue medication use (excluding prophylactic use for exercise-induced bronchospasm), and FEV1% of predicted norm. Each item is rated on a 7-point scale from 0 (least severe) to 6 (most severe). ACQ has been validated for self-administration (except for the FEV1 item, which is obtained by spirometry) and has high internal reliability (intra-class correlation coefficient=0.90). The overall ACQ score is an average of the item scores equally weighted. The proportion of responders is the percentage of participants achieving the MCID of at least a 0.5-point increase in ACQ scores. Percentages at each follow-up time point are secondary outcomes.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of Pre-bronchodilator measurements of FEV1 (Aim 1)
Description
Lung function will be assessed by forced spirometry as per the American Thoracic Society (ATS) standards, both before and after bronchodilator. Post-bronchodilator spirometry will be performed at 15 minutes and 2 hours after bronchodilator administration. Participants will be instructed to refrain from taking inhaled medications for breathing during the 6-24 hours prior to their visit depending on the medication, unless they are having trouble with their breathing. Participants will blow forcefully for at least 6 seconds for 3-8 times until 3 acceptable results show repeatability. Spirometry outcomes for Aim 1 include PRE-bronchodilator measurements of forced expiratory volume in 1 second (FEV1)
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of Pre-bronchodilator measurement of FVC (Aim 1)
Description
Lung function will be assessed by forced spirometry as per the American Thoracic Society (ATS) standards, both before and after bronchodilator. Post-bronchodilator spirometry will be performed at 15 minutes and 2 hours after bronchodilator administration. Participants will be instructed to refrain from taking inhaled medications for breathing during the 6-24 hours prior to their visit depending on the medication, unless they are having trouble with their breathing. Participants will blow forcefully for at least 6 seconds for 3-8 times until 3 acceptable results show repeatability. Spirometry outcomes for Aim 1 include PRE-bronchodilator measurements of forced vial capacity (FVC).
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of Pre-bronchodilator measurements FEV1/FVC (Aim 1)
Description
Lung function will be assessed by forced spirometry as per the American Thoracic Society (ATS) standards, both before and after bronchodilator. Post-bronchodilator spirometry will be performed at 15 minutes and 2 hours after bronchodilator administration. Participants will be instructed to refrain from taking inhaled medications for breathing during the 6-24 hours prior to their visit depending on the medication, unless they are having trouble with their breathing. Participants will blow forcefully for at least 6 seconds for 3-8 times until 3 acceptable results show repeatability. Spirometry outcomes for Aim 1 include PRE-bronchodilator measurements of FEV1/FVC.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of asthma medication adherence (Aim 1)
Description
The Adult Asthma Adherence Questionnaire is a validated and practical questionnaire that reflects nonadherence risk and identifies potential adherence barriers.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Count of episodes of poorly controlled asthma (Aim 1)
Description
Episodes of poorly controlled asthma will be assessed as per a modified ALA-ACRC definition if any of the following apply: (1) addition of oral corticosteroid (prednisone or prednisolone) to treat asthma symptoms or (2) unscheduled contact with a health care provider (ED visit, physician office, hospital) for asthma symptoms.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Measure overall health-related quality of life
Description
The 12-item Short-Form Health Survey (SF-12) is a 12-item version of the SF-36 that measures overall health-related quality of life. Physical and mental health composite scores are computed using the scores of 12 questions and range from 0 to 100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. Test-retest correlation is 0.89 for the physical health subscale and 0.76 for the mental health subscale.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of Blood pressure (BP) (Aim 1)
Description
The American Heart Association recommendations for BP measurement will be followed. Participants will be told not to engage in vigorous exercise, ingest food or caffeine, or smoke within a half hour of BP measurements. If a half hour has not elapsed, the BP measurements must be delayed until a half hour has passed. BP will be measured in the seated position after at least a 5-minute rest in a quiet room where no other activity is taking place and where temperature fluctuations are minimal. At baseline, both arms will be measured once and 2 more times on the arm with higher systolic reading using standard equipment at participating clinics. This same arm will be measured 3 times at each follow-up assessment. Wait 1 minute between each measurement.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of psychological distress (Aim 1)
Description
The Depression, Anxiety and Stress Scale-21 items (DASS21) is a set of 3 self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the 3 scales contains 7 items. Each item is scaled from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Each scale is scored as the sum of the item scores.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of sleep disturbance (Aim 1)
Description
Sleep quality will be assessed on the 8-item PROMIS sleep disturbance (SD) scale. It measures symptoms of insomnia. Each item is scaled from 1 (not at all) to 5 (very much).
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of sleep-related impairment (Aim 1)
Description
The 8-item PROMIS sleep-related impairment (SRI) scale measures symptoms of daytime sleepiness. Each item is scaled from 1 (not at all) to 5 (very much). Correlation between the SD short form and the Pittsburgh Sleep Quality Index (PSQI, hypothesized to measure similar attributes) is 0.83 and correlation between the SRI short form and the Epworth Sleepiness Scale (ESS, hypothesized to measure a related but slightly different construct, the propensity to doze during activities) is 0.46, similar to the correlations between the SD full banks and PSQI (0.85) and between SRI full banks and the ESS (0.45).
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Degree of bronchodilator responsiveness based on pre- and post-bronchodilator percent change in FEV1 (Aim 2)
Description
Bronchodilator responsiveness will be measured based on percent change in FEV1 from prebronchodilator to 15 minutes and 2 hours postbronchodilator. Forced spirometry will be performed as per the American Thoracic Society (ATS) standards both before and after bronchodilator. Post-bronchodilator spirometry will be performed at 15 minutes and 2 hours after bronchodilator administration. Participants will be instructed to refrain from taking inhaled medications for breathing during the 6-24 hours prior to their visit depending on the medication, unless they are having trouble with their breathing. Participants will blow forcefully for at least 6 seconds for 3-8 times until 3 acceptable results show repeatability.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of plasma short chain fatty acids (propionate, butyrate, and acetate) (Aim 2)
Description
Circulating short chain fatty acids (SCFA) will be measured with approximately 4 cc serum, aliquoted into 200 µl cryovials and kept frozen at -80°C. These samples will be shipped overnight on dry ice to the University of Michigan metabolomic core for measurement of propionate, butyrate and acetate, as circulating measures of products of gut microbial fermentation.
Time Frame
Baseline, 3 months
Title
Level of PBMC cytokines (Interferon-γ, IL-5, IL-17A, IL-10, IL-1β, IL-6, IL-8, TNFα) (Aim 2)
Description
To measure changes in adaptive and innate immune function pertinent to obese asthma, we will use the Tru-Culture® (myriad RBM tubes, 1 cc blood for each tube): one containing TruCulture® media + 0.1 μg/mL lipopolysaccharide, one containing TruCulture® media + 0.4 μg/mL anti-CD3, and one containing TruCulture® media alone. Samples will be incubated upright in a dry heat block at 37°C for 24 hours. Supernatant and cells will be isolated and frozen at -80°C, then shipped overnight on dry ice to the University of Vermont for cytokine and gene expression studies, respectively. For effects on T cell function pertinent to adaptive immunity we will measure cytokines pertinent to TH1 (interferon gamma), TH2 (IL-5), TH17 (IL-17A) and Tregs (IL-10) in media from cells incubated with anti-CD3 versus media alone. For effects on mononuclear cell responses pertinent to innate immunity, we will measure IL-1β, IL-6, IL-8 and TNFα in response to lipopolysaccharide versus media.
Time Frame
Baseline, 3 months
Title
Level of diet quality based DASH score (Aim 3)
Description
Dietary intake will be determined from 3 unannounced 24-hour dietary recalls (2 non-consecutive weekdays and 1 weekend day with a 2-week period) by interview using the US Department of Agriculture multiple pass method. The Nutrition Data System for Research (NDSR) (Minneapolis, MN) will be used for data collection and nutrient analysis. The DASH score using the National Health and Nutrition Survey (NHANES) method sums an individual's adherence points for 9 nutrients (total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium) based on the DASH diet plan. NDSR outputs will provide the values of these 9 nutrients.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of diet quality based on the dietary inflammatory index (DII) (Aim 3)
Description
The DII will be applied to dietary intake data collected using the 3 unannounced 24-hour dietary recalls. The DII is a scale developed using data from epidemiologic, animal and in-vitro studies and is a useful marker of diet quality as it quantifies the overall inflammatory potential of diet, which is calculated based on the known inflammatory effects of up to 45 component nutrients and foods.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of plasma carotenoids (Aim 3)
Description
4mL blood will be collected in an EDTA tube, centrifuged at 4oC, for 10 minutes at 3000g. Plasma will be stored at -80oC until analysis. High-performance liquid chromatography (HPLC) will be used to measure plasma carotenoid concentrations (lycopene, lutein, β-cryptoxanthin, α-carotene and β-carotene), as an objective indicator of fruit and vegetable intake. Carotenoids will be extracted from plasma samples (with canthaxanthin added as an internal standard) with a series of ethyl acetate and hexane washes. Chromatography will be performed on a Hypersil ODS column with a flow rate of 0.3 mL/min, using mobile phase of acetonitrile:dichloromethane:methanol (0.05% ammonium acetate (85:10:5, vol:vol)). Carotenoids will be detected at 470 nm using a photodiode array detector.
Time Frame
Baseline, 3 months, 6 months, 12 months
Other Pre-specified Outcome Measures:
Title
Level of self-efficacy for dietary change
Description
Self-efficacy for dietary change will be measured using the Eating Habits Confidence Survey. The Eating Habits Confidence Survey is a reliable and valid measure of dietary self-efficacy. Cronbach's alpha coefficients ranged from 0.85 to 0.93 for the 5 factors (resisting relapse, reducing calories, reducing salt, reducing fat, and behavioral skills). Test-retest reliabilities ranged from 0.43 to 0.64.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of social support for dietary change
Description
Social support for dietary change will be measured using the Social Support and Eating Habits Survey. Cronbach's alpha coefficients ranged from 0.70 to 0.83 for the friend and family social support subscales.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Level of patient activation
Description
The 13-item Patient Activation Measure (PAM) assesses patient's self-reported knowledge, skill, and confidence for self-managing his or her health condition. It demonstrated acceptable internal consistency (Conbrach's alpha = 0.81). The 13-item PAM score accounts for 92% of the variation in the activity measured by the original 22-item PAM. The score is also significantly correlated with general preventive behaviors and disease-specific self-management behaviors.
Time Frame
Baseline, 3 months, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older at study enrollment
Diagnosis of asthma with currently prescribed controller therapy (i.e., Step 2 or above) according to the 2020 asthma guideline update (EPR4)
Uncontrolled asthma on study screening based on Asthma Control Test (ACT) scores <20
Being able and willing to provide written informed consent and HIPAA authorization
Exclusion Criteria:
Inability to speak, read or understand English sufficiently to provide valid informed consent
Primary diagnosis of COPD (emphysema or chronic bronchitis)
Previous cardiovascular disease: coronary heart disease (myocardial infarction, angina pectoris, percutaneous coronary intervention, coronary artery bypass graft surgery), cerebrovascular disease (stroke, transient ischemic attack), peripheral vascular disease, heart failure, or aortic aneurysm
Diabetes (other than during pregnancy)
Diagnosis of cancer (other than non-melanoma skin cancer) within the past year and/or actively receiving cancer treatment
Inflammatory bowel disease, colostomy, malabsorption, or major gastrointestinal resection
Diagnosis of bipolar or psychotic disorder
Hospitalization for psychological or emotional problems within the last 2 years
Cognitive impairment based on the Callahan 6-item screener67
Terminal illness or in hospice or long-term care
Current diet of good quality (DASH concordance index ≥6 out of 9 total)
Current/planned participation in another structured program that overtly focuses on diet and nutrition
On special diet that precludes changes adherent to the DASH dietary pattern or otherwise unwillingness to modify current diet
Current use of prescription or non-prescription weight-loss products and unwillingness to stop taking them for the duration of the study
Underweight per body mass index (BMI) below 18.5 kg/m2 based on measured height and weight at study enrollment
Actively attempting to lose weight or weight change >15 lbs during prior 3 months
Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)68
Current within the past 6-months or former smoker (more than 20-packs of cigarettes in the lifetime, or current smoker)
Current or planned pregnancy or currently lactating
Planning to move out of the area during the study period
Participation in another clinical trial or investigational treatment study
Family/household member of an already enrolled participant or of a study team member
Investigator discretion for clinical safety or protocol adherence reasons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ma, MD, PhD
Phone
312-413-9830
Email
maj2015@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amruta Barve, MPH
Phone
7377810681
Email
amruta@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ma, MD, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ma, MD, PhD
Phone
312-413-9830
Email
maj2015@uic.edu
First Name & Middle Initial & Last Name & Degree
Amruta Barve, MPH
Phone
7377810681
Email
amruta@uic.edu
Facility Name
UIC CCTS Clinical Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryann Holtman
Email
mholt@uic.edu
First Name & Middle Initial & Last Name & Degree
Amruta Barve
Phone
Charity Ball
Email
chball@uic.edu
12. IPD Sharing Statement
Learn more about this trial
Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern
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