N/A
N=684
INtervention Study In overweiGHT Patients With COPD
Pulmonary Disease, Chronic Obstructive · Obesity · Weight Loss · Life Style · Overweight
Bottom Line
View on ClinicalTrials.gov: NCT02634268 ↗Enrolled (actual)
684
Serious AEs
22.4%
Results posted
Feb 2022
Primary outcome: Primary: Six Minute Walk Test — 1071.0; 1005.9 feet — p=.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lifestyle Intervention (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Six Minute Walk Test |
1071.0; 1005.9 | .02 sig |
| SECONDARY Modified Borg Scale |
2.7; 3.2 | .0008 sig |
| SECONDARY Weight |
91.0; 93.7 | 0.0008 sig |
| SECONDARY Short Form 12 Health Survey (SF-12) Physical Component Score (PCS) |
39.7; 37.5 | 0.01 sig |
| SECONDARY Short Form 12 Health Survey (SF-12) Mental Component Score (MCS) |
51.7; 51.4 | 0.45 |
| SECONDARY Non-laboratory Framingham Risk Score |
15.0; 15.4 | 0.009 sig |
| SECONDARY Waist Circumference |
111.3; 113.1 | 0.13 |
| SECONDARY Systolic Blood Pressure |
129.5; 128.8 | 0.64 |
| SECONDARY Body Mass Index (BMI) |
31.9; 32.7 | 0.004 sig |
| SECONDARY St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score |
52.6; 54.9 | 0.09 |
| SECONDARY St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score |
58.9; 63.3 | 0.12 |
| SECONDARY St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score |
29.2; 32.8 | 0.03 sig |
| SECONDARY St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score |
42.4; 46.1 | 0.03 sig |
Summary
Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. The investigators are trying to find out if a program proven to help people lose a modest amount of weight and increase their physical activity will improve COPD symptoms for those with a high BMI. The program uses a series of video sessions and self-study handouts focused on healthy eating and increasing physical activity, and encourages participants to monitor their weight, diet, and physical activity for one year. For those who want to, they will be able to work with a health coach to help meet weight and activity goals. We hope that the program will lead to improved exercise tolerance, body weight, dyspnea, generic health-related quality of life, and major cardiovascular risk factors (central obesity by waist circumference, Framingham Risk Score, and blood pressure) through 12 months of follow-up. To be in the study, participants will need to have COPD, high BMI, history of smoking, shortness of breath, and be at least 40 years old.
Eligibility Criteria
Inclusion Criteria
- 40 years or older at time of eligibility screening;
- Body mass index 25.0-44.9 kg/m2 (also see Figure 2);
- Smoked more than 10 pack-years of cigarettes;
- Shortness of breath;
- COPD;
- Able to participate fully in all study protocol/procedures including written informed consent process.
Exclusion Criteria
- Inability to speak, read, or understand English;
- Active weight loss interventions;
- Expected weight loss because of alternate explanations, such as from illness;
- Unable to ambulate to weight scale for weight measurement;
- Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy <18 months;
- Pregnant, lactating, or planning to become pregnant during the study period;
- Participation in other intervention studies.
Data sourced from ClinicalTrials.gov (NCT02634268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.