Recruiting

Health Behaviour

Sponsor:

University of Alberta

Code:

NCT06038032

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Digital wellness platform

Online healthcare professional support

Study Details

Brief summary:

RESILIENCE is 24-week randomized controlled trial that assesses the efficacy of a digital wellness platform, combined with online support from healthcare professionals, to enhance waist circumference and other vital health outcomes in endometrial cancer survivors.

Conditions

Endometrial Cancer

Study ID

NCT06038032

Start date

Mar 25, 2024

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.
  • Self-reported BMI ≥25 and ≤45 kg/m2, or self-reported BMI ≥18.5 and ≤24.9 kg/m2 together with a cardiometabolic condition or waist circumference ≥80 cm. Cardiometabolic conditions are also self-reported and included type 2 diabetes, prediabetes, hypertension, dyslipidemia, coronary artery disease, and stroke among others.
  • 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.

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention group

Participants will receive the intervention for 24 weeks. The first 16 weeks will involve an intensive behavioral program (digital wellness platform plus online healthcare professional support), followed by an 8-week maintenance period (digital wellness platform alone).

At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.

no intervention: Control group

At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.

Interventions

Digital wellness platform

A digital wellness platform based on preventive self-care that contains tools to monitor nutrition, physical activity, and mental wellbeing will be accessed daily for 24 weeks.

Online healthcare professional support

Individual sessions with a registered dietitian, an exercise professional, and a mental health therapist for 16 weeks.

Primary outcome measure

  • Change from baseline in waist circumference at week 16. [ Time Frame: Baseline to week 16 ]

Central Contacts and Locations

Central contacts

Teresita Gormaz, MSc

780-492-1151resilience.trial@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2E1

Contacts

Carla Prado, PI

7804927934carla.prado@ualberta.ca

Teresita Gormaz, MSc

7804927820gormazre@ualberta.ca

University of Toronto

Recruiting

Toronto, Canada

Contacts

Amy A Kirkham, PhD

416-946-4069amy.kirkham@utoronto.ca

Principal Investigator:

Amy A Kirkham, PhD

More Information

Sponsor

University of Alberta

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.