Pilot of Lifestyle and Asthma Intervention (PLAN)
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|ClinicalTrials.gov Identifier: NCT03291808|
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : January 12, 2018
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: Weight loss intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot of Lifestyle and Asthma Intervention|
|Actual Study Start Date :||November 15, 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||April 2020|
Experimental: Weight loss intervention
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.
Behavioral: 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.
- 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.
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): NCT03291808
|United States, Arizona|
|University of Arizona||Not yet recruiting|
|Tucson, Arizona, United States, 85724|
|Contact: Lynn Gerald, PhD firstname.lastname@example.org|
|United States, Vermont|
|University of Vermont||Recruiting|
|Burlington, Vermont, United States, 05401|
|Contact: Anne Dixon, MD Anne.Dixon@uvmhealth.org|
|Principal Investigator:||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|