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 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
NCT ID:
NCT06038032
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years old
* Histologically confirmed endometrioid adenocarcinoma (low-grade), FIGO 2009 stages I to III.
* 1 month to 10 years post-surgery and completion of adjuvant treatment.
* BMI ≥25 and ≤45 kg/m2.
* Willing and able to adhere to the study interventions and assessments
* Seeking best weight using the readiness to change questionnaire.
* Have a cell phone compatible with the Fitbit app with internet access and Bluetooth capabilities.
* Able to speak, read and understand English.
Exclusion Criteria:
* Recurrent (local, regional, or distant) or metastatic EC.
* Abnormal (i.e., mutated) p53 status in combination with FIGO 2009 stage III or IV
* Weight fluctuations (±5 kg) within the previous 3 months.
* Planned surgery in the next 6 months.
* Previous bariatric surgery.
* Uncontrolled thyroid disorder
* Type 1 diabetes.
* Type 2 diabetes with HbA1c \> 10% or are taking insulin, sulfonylureas, or GLP-1 agonists.
* Taking corticosteroids.
* Taking anti-obesity drugs.
* Current smoker (of any type, e.g e-cigarettes, tobacco, marihuana, vaping)
* Self-report \>90 moderate-intensity min/week of aerobic physical activity on average over the past three months.
* Potential safety risk with exercise or maximal exercise testing screened with the 2023 Physical Activity Readiness Questionnaire (PAR-Q+)53, signs and symptoms of CVD, and any of the American Heart Association's absolute or relative contraindications to exercise testing.
* Physical or mobility limitations impacting ability to perform physical activity.
* Self-report following a structured hypocaloric diet (e.g., using formulated meal replacements, weight loss meal program) or a restrictive diet (intermittent fasting, or high-fat diet) in the past three months, or self-report currently following a vegan diet but for less than two years.
* Self-reported history of an eating disorder diagnosed by a physician.
* Intending to be away longer than 2 weeks consecutively during the intervention and unable to adhere to the study protocol during this period.
* Active substance abuse (alcohol, cannabis, illicit drugs, prescription drugs).
* Dual-energy x-ray absorptiometry (DXA) or magnetic resonance imaging (MRI) contraindications for research purposes, such as pacemakers or pregnancy
* Unable to participate in telephone and virtual intervention protocols (e.g., having a severe hearing or vision loss).
* Unable to adhere to the study protocol (i.e., unavailable to commit to scheduled group video conferencing sessions; limited access to the Internet; not willing to use platform, individuals who have been advised by a health professional not to lose weight or reduce caloric intake; cognitive impairment or dementia; etc.).
* Unable to come to study location.
* Unable to provide written informed consent.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06038032
Study Brief:
Protocol Section:
NCT06038032