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Weight Loss Program for Obesity
N/A
Waitlist Available
Led By Marla Lujan, PhD
Research Sponsored by Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Previous diagnosis of bleeding disorder(s) or current use of blood thinners/anticoagulants
Lack of one or both ovaries and/or uterus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 13 months
Awards & highlights
Summary
This trial looks at the effects of weight loss on different aspects of health in obese women, specifically those with regular versus irregular menstrual cycles and/or PCOS.
Who is the study for?
This trial is for overweight women with a BMI of 30 or higher who have either regular or irregular menstrual cycles, or PCOS. They should not be on hormonal birth control, fertility treatments, or insulin medication recently. Women without ovaries/uterus, vegans/gluten-free diets, those pregnant/nursing/lactating, with bleeding disorders or on blood thinners, and soy/peanut allergies cannot join.Check my eligibility
What is being tested?
The study aims to see how a commercial weight loss program affects body composition, metabolism status, reproductive hormones and ovarian function in obese women with different menstrual cycle regularities including those with PCOS.See study design
What are the potential side effects?
While the trial itself does not involve medications that typically cause side effects like drugs do; potential side effects may include nutritional deficiencies or physical stress due to diet changes from the weight loss program.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a bleeding disorder or am currently on blood thinners.
Select...
I do not have one or both of my ovaries and/or my uterus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 13 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Ovulatory Function
Secondary outcome measures
Change from Baseline Body Composition
Change from Baseline Menstrual Function
Change from Baseline Metabolic Status
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Overweight WomenExperimental Treatment1 Intervention
Regardless of reproductive history, each participant will be provided with six months of the commercial weight loss program, Nutrisystem® D. Nutrisystem® D is a portion-controlled, low calorie, and low glycemic index meal delivery system that provides 1250-1500 kcal/day. It has been proven to help overweight adults achieve real and sustainable weight loss results. When meals and snacks are consumed as instructed, average weight loss is 1-2 lbs per week or 15-20% body weight by the end of six months. Nutrisystem® D offers a balanced meal plan that is consistent with the nutrition recommendations of the USDA for Americans and American Diabetes Association. Each participant will be encouraged to take a daily multivitamin to help meet her micronutrient needs on the program.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,683,466 Total Patients Enrolled
2 Trials studying Anovulation
35 Patients Enrolled for Anovulation
Cornell UniversityLead Sponsor
167 Previous Clinical Trials
14,089,923 Total Patients Enrolled
Nutrisystem, Inc.Industry Sponsor
9 Previous Clinical Trials
678 Total Patients Enrolled
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