Trial Outcomes & Findings for Pilot of Lifestyle and Asthma Intervention (NCT NCT03291808)
NCT ID: NCT03291808
Last Updated: 2022-09-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
6 months
Results posted on
2022-09-21
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Research burden
|
4
|
Baseline Characteristics
Pilot of Lifestyle and Asthma Intervention
Baseline characteristics by cohort
| Measure |
Weight Loss Intervention
n=43 Participants
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.
|
|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=5 Participants
|
|
Forced Expiratory Vital Capacity %
|
80 Percent predicted
n=5 Participants
|
|
Forced Vital Capacity %
|
85 Percent predicted
n=5 Participants
|
|
Forced Expiratory Vital Capacity/Forced vital capacity
|
79 Percent predicted
n=5 Participants
|
|
Asthma Control Test (ACT)
|
14 units on a scale
n=5 Participants
|
|
Asthma Symptom Utility Index, ASUI
|
.6 units on a scale
n=5 Participants
|
|
Marks Asthma Quality of Life Questionnaire
|
28 units on a scale
n=5 Participants
|
|
Standard Brief activity survey (SBAS)
Inactive
|
11 Participants
n=5 Participants
|
|
Standard Brief activity survey (SBAS)
Light intensity
|
23 Participants
n=5 Participants
|
|
Standard Brief activity survey (SBAS)
Moderate Intensity
|
6 Participants
n=5 Participants
|
|
Standard Brief activity survey (SBAS)
Hard Intensity
|
1 Participants
n=5 Participants
|
|
Standard Brief activity survey (SBAS)
Very Hard intensity
|
1 Participants
n=5 Participants
|
|
Standard Brief activity survey (SBAS)
Unknown
|
1 Participants
n=5 Participants
|
|
SF-36 Short forrm Survey Instrument
|
53 units on a scale
n=5 Participants
|
|
Impact of Weight on Quality of Life-Lite
|
55 units on a scale
n=5 Participants
|
|
Treatment Motivation and Readiness (TRE-MORE)
|
3 units on a scale
n=5 Participants
|
|
Systemic corticosteroids
yes
|
29 Participants
n=5 Participants
|
|
Systemic corticosteroids
no
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Weight Loss Intervention
n=43 Participants
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.
|
|---|---|
|
Weight Loss
|
43 Participants
|
Adverse Events
Weight Loss Intervention
Serious events: 11 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Weight Loss Intervention
n=43 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbations
|
11.6%
5/43 • Number of events 8 • 6 months
|
|
General disorders
Emergency Department visit
|
9.3%
4/43 • Number of events 11 • 6 months
|
|
Gastrointestinal disorders
Small bowel obstruction
|
4.7%
2/43 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Cardiac disorders
Chest pain with other symptoms
|
2.3%
1/43 • Number of events 6 • 6 months
|
|
General disorders
Fall
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypertension
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Immune system disorders
Allergic reaction
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
General disorders
|
2.3%
1/43 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Weight Loss Intervention
n=43 participants at risk
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.
|
|---|---|
|
General disorders
Chest pain with other symptoms
|
14.0%
6/43 • Number of events 6 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place