the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the effectiveness of a 12-month comprehensive weight management program on weight change in overweight/obese patients following treatment for endometrial cancer. During the study period, subjects will be monitored for recurrence during routine clinic visits A secondary exploratory purpose of this study will be to evaluate the gut microbiome in this intervention group and the changes that may occur while participating in a weight loss and weight management program.

Detailed Description
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All enrolled subjects will participate in the Profile weight loss and weight management program for a period of 12 months. They will work with a Profile lifestyle coach weekly to develop a personalized nutrition plan, discuss their activity, and lifestyle behavior as done with all Profile members. A comparison of similar retrospective chart reviews based on age, weight in pounds and stage of cancer will be conducted using the Electronic Medical Record (EMR). All enrolled subjects will collect and return a fecal specimen prior to beginning the weight management plan and again after 6 months of participation. The stool sample will be used to understand gut health.

Official Title
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Preliminary Trial to Evaluate the Effectiveness of the Profile by Sanford Weight Management Program in Endometrial Cancer Patients

Conditions
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Endometrial Cancer, Overweight

Intervention / Treatment
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* Behavioral: Profile by Sanford weight management plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older with a diagnosis of endometrial cancer No known metastatic disease Has completed all treatment for their endometrial cancer at least 2 months prior to enrollment. Has a BMI (Body Mass Index) of 30 or higher Ability to understand the purpose of study and willingness to sign consent Willingness to collect fecal specimens at the required time points Capable of following the dietary guidelines and instructions for the Profile weight management plan Agrees to sharing information between Profile and Sanford Research study personnel Exclusion Criteria: BMI (Body Mass Index) less than 30 Known metastatic disease Receiving treatment or expected to receive treatment for endometrial cancer or any other cancer Any psychological, familial, sociological conditions that the physician feels will interfere with medical follow-up and compliance on the study Taking insulin for diabetes (oral medications for diabetes allowed) Use of corticosteroids for a chronic medical condition Known liver disease Bowel or stomach disorders that the physician feels would interfere with Profile participation. Any history of malabsorption syndrome or substantial amounts of small bowel or stomach surgery that impairs nutrient absorption

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All enrolled patients will participate in the Profile weight management program
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Profile by Sanford<br>All enrolled subjects are assigned to participate in the Profile by Sanford weight management program for a period of 12 months..Subjects will follow the Profile program and will be provided a nutritional plan which includes consuming Profile nutritional supplements and other food items. Subjects will work with a Profile lifestyle coach to develop a personalized nutrition plan, discuss their activity, and lifestyle behavior. Subjects on this research study will follow the Profile by Sanford weight loss and management plan as all Profile members. All enrolled subjects will collect and return a fecal specimen prior to beginning the Profile by Sanford weight management plan and again after 6 months of participation. | Behavioral: Profile by Sanford weight management plan<br>* The purpose of this study is to observe weight changes in patients who completed endometrial cancer treatment, are clinically overweight, and who participate in the Profile by Sanford weight management program. An exploratory purpose is to examine the bacterial content of the patient's gut by examining stool specimens before starting the Profile by Sanford weight management program and after 6 months of participation in the Profile by Sanford weight management program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine weight change from baseline to 6 months. | All enrolled subjects will be weighed in pounds and the difference from baseline to 6 months will be recorded. | 6 months after starting weight management program | 
| Determine weight change from baseline to 12 months. | All enrolled subjects will be weighed in pounds and the difference from baseline to 12 months will be recorded. | 12 months after starting weight management program |