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

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ClinicalTrials.gov Identifier: NCT03908996
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sanford Health

Tracking Information
First Submitted Date  ICMJE August 14, 2018
First Posted Date  ICMJE April 9, 2019
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE February 11, 2019
Estimated Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03908996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer
Official Title  ICMJE Preliminary Trial to Evaluate the Effectiveness of the Profile by Sanford Weight Management Program in Endometrial Cancer Patients
Brief Summary 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
All enrolled patients will participate in the Profile weight management program
Masking: None (Open Label)
Masking Description:
A participant will not be informed of the analysis done on their stool samples. The results of the testing done on a participants stool sample will not be entered into the participants medical record.
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Cancer
  • Overweight
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Profile by Sanford weight management plan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 7, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 15, 2020
Estimated Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Patients who has a diagnosis of endometrial cancer and have completed standard of care treatment.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jan Wernisch, BSN 605-312-3324 janet.wernisch@sanfordhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03908996
Other Study ID Numbers  ICMJE SH Profile II
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sanford Health
Study Sponsor  ICMJE Sanford Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Bell, MD Sanford Health
PRS Account Sanford Health
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP