Asthma
Conditions
Keywords
Obesity, Asthma, Weight loss
Brief 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). 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.
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
Interventions
BEHAVIORALWeight 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.
Sponsors
American Lung Association
National Heart, Lung, and Blood Institute (NHLBI)
University of Vermont
University of Arizona
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Research burden | 4 |
Baseline characteristics
| Characteristic | Weight Loss Intervention |
|---|---|
| Age, Continuous | 48 years |
| Asthma Control Test (ACT) | 14 units on a scale |
| Asthma Symptom Utility Index, ASUI | .6 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Forced Expiratory Vital Capacity % | 80 Percent predicted |
| Forced Expiratory Vital Capacity/Forced vital capacity | 79 Percent predicted |
| Forced Vital Capacity % | 85 Percent predicted |
| Impact of Weight on Quality of Life-Lite | 55 units on a scale |
| Marks Asthma Quality of Life Questionnaire | 28 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 43 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 5 Participants |
| SF-36 Short forrm Survey Instrument | 53 units on a scale |
| Standard Brief activity survey (SBAS) Hard Intensity | 1 Participants |
| Standard Brief activity survey (SBAS) Inactive | 11 Participants |
| Standard Brief activity survey (SBAS) Light intensity | 23 Participants |
| Standard Brief activity survey (SBAS) Moderate Intensity | 6 Participants |
| Standard Brief activity survey (SBAS) Unknown | 1 Participants |
| Standard Brief activity survey (SBAS) Very Hard intensity | 1 Participants |
| Systemic corticosteroids no | 14 Participants |
| Systemic corticosteroids yes | 29 Participants |
| Treatment Motivation and Readiness (TRE-MORE) | 3 units on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 6 / 43 |
| serious Total, serious adverse events | 11 / 43 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Weight Loss Intervention | Weight Loss | 43 Participants |
p-value: 0.35Kruskal-Wallis