Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT01500356
Eligibility Criteria:
Inclusion Criteria:
* 18-55 years of age.
* Body mass index (BMI) between 25.0 to \<40.0 kg/m2.
* Ability to provide informed consent prior to participation in this study.
Exclusion Criteria:
* Females who are currently pregnant or breastfeeding, or reporting that she is planning a pregnancy within the next 12 months.
* History of bariatric surgery.
* Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: cancer (Note: Persons previously diagnosed with non-melanoma skin cancers, those successfully treated for cancer who have remained disease-free for five years or more would be eligible for participation in this study); diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.
* Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e. recent or recurrent DVT).
* Resting systolic blood pressure of \>160 mmHg or resting diastolic blood pressure of \>100 mmHg.
* Eating disorders that would contraindicate weight loss or physical activity.
* Alcohol or substance abuse.
* Currently treated for psychological issues (i.e., depression, bipolar disorder, etc), taking psychotropic medications within the previous 12 months, or hospitalized for depression within the previous 5 years.
* Report exercise on \>3 days per week for \>20 minutes per day over the past 3 months. (NOTE: It is important that individuals are sedentary when entering this study to allow for maximal effect of the intervention.)
* Report weight loss of \>5% or participating in a weight reduction diet in the past 3 months.
* Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01500356
Study Brief:
Protocol Section:
NCT01500356