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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT01855932
Eligibility Criteria:
Inclusion Criteria:
* BMI greater than 25-39.9 kg/m2
* Weigh no more than 300 pounds.
* Weight stable (no loss or gain \>25 lbs for the past 6 months)
* Not enrolled in any formal weight loss program
* Not currently taking anti-obesity medications
* Interested in losing weight
* Own an Android Smartphone or iPhone, be willing to install the Lose It! Application, and agree to join the Enlighten group which will allow study staff to view participant data using a private coaching interface.
Exclusion Criteria:
* Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
* History of diabetes requiring insulin supplementation
* Crohn's Disease
* Diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
* Require use of an assistive device for mobility (e.g., wheelchair, walker, cane)
* BMI greater than or equal to 40, weight greater than or equal to 300 pounds
* Hospitalization for a psychiatric disorder within the past 5 years
* Those at risk for adverse cardiovascular (CVD) events with moderate intensity activity
* Those who cannot read the study questionnaires will be excluded
* Those currently taking weight loss medication or committed to following an incompatible dietary regimen.
* Female participants may not be pregnant, trying to get pregnant, or lactating.
* Bulimia Nervosa
* Binge Eating Disorder
* Active Suicidal Ideation
* those on medications known to cause weight gain (e.g., prednisone)
* current substance abuse or dependence besides nicotine dependence
* low motivation to change that would interfere with program adherence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01855932
Study Brief:
Protocol Section:
NCT01855932