INtervention Study In overweiGHT Patients With COPD (INSIGHT COPD)

S

Seattle Institute for Biomedical and Clinical Research

Status

Completed

Conditions

Weight Loss
Overweight
Life Style
Pulmonary Disease, Chronic Obstructive
Obesity

Treatments

Behavioral: Lifestyle Intervention

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02634268
1U01HL128868

Details and patient eligibility

About

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.

Enrollment

684 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

684 participants in 2 patient groups

Lifestyle intervention
Active Comparator group
Description:
Behavioral lifestyle intervention focused on healthy eating and physical activity
Treatment:
Behavioral: Lifestyle Intervention
Usual Care
No Intervention group
Description:
Participants continue with usual diet and exercise activities as they desire

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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