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

March 17, 2021 updated by: Sanford Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Roger Maris Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Gynecological Oncology clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Profile by Sanford
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine weight change from baseline to 6 months.
Time Frame: 6 months after starting weight management program
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.
Time Frame: 12 months after starting weight management program
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanford Health

Investigators

  • Principal Investigator: Maria Bell, MD, Sanford Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2019

Primary Completion (Actual)

January 11, 2021

Study Completion (Actual)

January 11, 2021

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

April 7, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH Profile II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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