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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL136755 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| American Lung Association | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Vermont | OTHER |
| University of Arizona |
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This is to pilot test a weight loss intervention in obese patients with poorly controlled asthma.
Obesity is a risk factor for the development of asthma (approximately 250,000 cases per year of asthma in the U.S. are related to obesity).
Investigators' ultimate purpose is to test the hypothesis that weight loss through an intensive life style intervention will improve asthma control. But investigators first need to establish whether the weight loss intervention is effective in patients with asthma.
Objectives
This will be a pilot study of a weight loss intervention at two centers, the University of Arizona and the University of Vermont. The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control.
This will be a single arm-phase II futility trial; the "futility" to be assessed is the ability to produce weight loss. Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials. This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss). This is a 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention, which is described in detail below
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight loss intervention | Experimental | Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials. This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss).18 Therefore, this will be a single arm 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss intervention | Behavioral | This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly "group meetings" in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control. | 6 months |
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Inclusion Criteria:
Physician diagnosis of asthma on regular prescribed controller therapy for at least 3 months
Age: ≥18 years of age
Obese: BMI > 30 kg/m2
Poorly controlled asthma
Ability and willingness to provide informed consent
Ability to access internet weight loss program for trial period
Completion of asthma diary cards and weight loss diary cards for same 3 consecutive days at visit 2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Dixon, MD | University of Vermont | Principal Investigator |
| Robert Wise, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Janet Holbrook, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States | ||
| University of Vermont |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35304842 | Derived | Johnson O, Gerald LB, Harvey J, Roy G, Hazucha H, Large C, Burke A, McCormack M, Wise RA, Holbrook JT, Dixon AE. An Online Weight Loss Intervention for People With Obesity and Poorly Controlled Asthma. J Allergy Clin Immunol Pract. 2022 Jun;10(6):1577-1586.e3. doi: 10.1016/j.jaip.2022.02.040. Epub 2022 Mar 15. |
| Label | URL |
|---|---|
| Related Info | View source |
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Forty-eight participants were screened for the study intervention and entered a 4-week run-in period; five were excluded from enrolling into the weight loss intervention because they did not complete three consecutive days recording food intake, physical activity, weight and asthma symptoms.
Forty-three were enrolled in the weight loss intervention in five cohorts, four English speaking and one Spanish speaking. Ten subjects dropped out before study completion, four reported this was related to research burden and six were lost to follow up: 33 participants completed the 6-month study. Recruitment was conducted at University of Vermont and University of Arizona.
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| ID | Title | Description |
|---|---|---|
| FG000 | Weight Loss Intervention | This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss). Therefore, this will be a single arm 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention. Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials. Weight loss intervention: This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly "group meetings" in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
People with poorly controlled asthma with a BMI of greater than 30
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| ID | Title | Description |
|---|---|---|
| BG000 | Weight Loss Intervention | This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss). Therefore, this will be a single arm 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention. Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials. Weight loss intervention: This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly "group meetings" in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Loss | The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control. | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Weight Loss Intervention | Weight loss intervention: This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly "group meetings" in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma Exacerbations | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain with other symptoms | General disorders | Systematic Assessment | Other symptoms such as fall, hypertension, allergic reaction, knee pain, unknown |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gem Roy | Johns Hopkins University | 4432875796 | groy2@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2020 | May 12, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2017 | May 12, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| OTHER |
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|
| Burlington |
| Vermont |
| 05401 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Forced Expiratory Vital Capacity % | Median | Inter-Quartile Range | Percent predicted |
|
| Forced Vital Capacity % | Median | Inter-Quartile Range | Percent predicted |
|
| Forced Expiratory Vital Capacity/Forced vital capacity | Median | Inter-Quartile Range | Percent predicted |
|
| Asthma Control Test (ACT) | range 5-25, higher score indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Asthma Symptom Utility Index, ASUI | range 0-1, higher score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Marks Asthma Quality of Life Questionnaire | Range, 1-80, lower score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Standard Brief activity survey (SBAS) | SBAS is used to categorize patients based on activity level into:
| Count of Participants | Participants |
|
| SF-36 Short forrm Survey Instrument | Range 0-100, higher score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Impact of Weight on Quality of Life-Lite | Range 0-100, higher score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Treatment Motivation and Readiness (TRE-MORE) | range 0-5, higher score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Systemic corticosteroids | Count of Participants | Participants |
|
|
|
|
| 0 |
| 43 |
| 11 |
| 43 |
| 6 |
| 43 |
| Emergency Department visit | General disorders | Systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Chest pain with other symptoms | Cardiac disorders | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| General disorders | Systematic Assessment |
|
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |