Pilot of Lifestyle and Asthma Intervention (PLAN)

Johns Hopkins University

Status: Completed

Conditions: Asthma

Treatments: Behavioral: Weight loss intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03291808

IRB00141509

R34HL136755 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

1. 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.
2. The ultimate purpose is to implement a multi-center weight loss intervention trial for obese patients with poorly controlled asthma.

Full 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

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

  • Asthma Control Test Score < 19,19,20 or
  • Use of rescue inhaler, on average, > 2 uses/week for preceding month, or
  • 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

Exclusion criteria

• 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 design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Weight loss intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Weight loss intervention