AsthmaPLANNCT03291808
Pilot of Lifestyle and Asthma Intervention
A study testing Weight loss intervention in people with Asthma, run by Johns Hopkins University at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2017to 31 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Asthma Control Test Score < 19,19,20 or
- Use of rescue inhaler, on average, > 2 uses/week for preceding month, or
Show all 11Show fewer
- Nocturnal asthma awakening, on average,1 or more times / week in preceding month, or
- Emergency Department (ED)/hospital visit or prednisone course for asthma in past six months
- 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
Who cannot join
- Prior history of bariatric surgery
- Any condition that puts the participant at risk from participation in a weight loss study or a condition that precludes participation in regular exercise as judged by the site physician.
- Pregnancy (by patient self-report)
- Participation in another weight loss intervention within the last month
- Weight loss of ≥ 10 pounds in the last 6 months by self-report
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Vermont
Burlington, Vermont, 05401
University of Arizona
Tucson, Arizona, 85724
About this study
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).
Read more
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
- The primary objective of this study is to determine the effectiveness of an internet-based weight loss intervention in producing weight loss in obese patients with poorly controlled asthma.
- The ultimate purpose is to implement a multi-center weight loss intervention trial for obese patients with poorly controlled asthma.
Read the detailed description
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
- Conditions
- Asthma
- Being tested
- Weight loss intervention
- Keywords
- Obesity, Asthma, Weight loss
- Medical subject headings
- Asthma, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start15 Nov 2017
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association, National Heart, Lung, and Blood Institute (NHLBI), University of Vermont, University of Arizona
- Responsible party
- Sponsor
- Investigators
- Anne Dixon, MD, Principal investigator, University of VermontRobert Wise, MD, Principal investigator, Johns Hopkins School of MedicineJanet Holbrook, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291808
- Sponsor's protocol ID
- IRB00141509
- Other IDs
- R34HL136755
- Acronym
- PLAN
- Status last verified
- Aug 2022
- First submitted
- 21 Sep 2017
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35304842
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Lifestyle and Asthma Intervention
- ClinicalTrials.gov ID
- NCT03291808
- Acronym / sponsor ID
- PLAN / IRB00141509
- Conditions
- Asthma
- Keywords
- Obesity, Asthma, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Lung Association, National Heart, Lung, and Blood Institute (NHLBI), University of Vermont, University of Arizona
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- The primary objective of this study is to determine the effectiveness of an internet-based weight loss intervention in producing weight loss in obese patients with poorly controlled asthma.
- The ultimate purpose is to implement a multi-center weight loss intervention trial for obese patients with poorly controlled asthma.
Detailed description
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight loss intervention | Experimental | Behavioral: Weight loss interventionSuch 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- Prior history of bariatric surgery
- Any condition that puts the participant at risk from participation in a weight loss study or a condition that precludes participation in regular exercise as judged by the site physician.
- Pregnancy (by patient self-report)
- Participation in another weight loss intervention within the last month
- Weight loss of ≥ 10 pounds in the last 6 months by self-report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss interventionThis 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. | Behavioural | Weight loss intervention |
Primary outcome
Weight Loss
Time frame: 6 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35304842Johnson 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Dixon, MD principal investigator
University of Vermont
Robert Wise, MD principal investigator
Johns Hopkins School of Medicine
Janet Holbrook, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss intervention in people with Asthma, run by Johns Hopkins University 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 5 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 21 Sep 2022. 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?
Yes. Results are posted in the registry (first posted 21 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight Loss (time frame: 6 months). 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 NCT03291808, which also lists 1 linked publication.
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 21 Sep 2022.