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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL108753 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Kaiser Permanente | OTHER |
| Stanford University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Usual Care | |
| DASH Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Approaches to Stop Hypertension dietary pattern | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-months post-randomizaton |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function | Lung function measured by spirometry | 6-months post-randomization |
| Asthma specific Quality of Life | Juniper Mini Asthma Quality of Life Questionnaire (Mini-AQLQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Ma, MD, PhD | Palo Alto Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente, Hayward Medical Center, Allergy Department | Hayward | California | 94545 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33871602 | Derived | 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. | |
| 25343191 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 6-months post-randomization |
| 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. | 6-months post-randomization |
| 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 | 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. | 6-months post-randomization |
| Psychosocial predictors of dietary change | Self-efficacy and social support for dietary change will be assessed using previously validated instruments. | 6-months post-randomization |
| 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. | 6-months post-randomization |
| 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. | 6-months post-randomization |
| Kaiser Permanente, San Francisco Medical Center, Allergy Department |
| San Francisco |
| California |
| 94115 |
| United States |
| 23648395 | Derived | 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |