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Commercial Weight Loss Program for Anovulation

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 13 months
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 13 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 13 months for reporting.

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 more

Trial 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.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,684 Total Patients Enrolled
2 Trials studying Anovulation
35 Patients Enrolled for Anovulation
Cornell UniversityLead Sponsor
166 Previous Clinical Trials
14,089,803 Total Patients Enrolled
Nutrisystem, Inc.Industry Sponsor
9 Previous Clinical Trials
678 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would best be helped by participating in this research project?

"Eligible participants for this trial must not have had a menstrual cycle in the last 3 months, be between 18-35 years old, and there are plans to enroll around 100 individuals."

Answered by AI

If I wanted to participate in this research, what would be the next steps?

"That is correct. The information available on clinicaltrials.gov indicates that this research project, which was originally advertised on 01/01/2013, is still looking for participants. They have updated the listing as recently as 09/23/2022 and are currently 100 people short of their goal number at 1 location."

Answered by AI

Can people of an older age group qualify for this research project?

"In order to be eligible for this study, applicants must be aged 18-35. Out of the total number of trials, 67 are for patients that are under 18 and 251 are meant for those over 65 years old."

Answered by AI

What is the target sample size for this research project?

"According to the information available on clinicaltrials.gov, this clinical trial is currently recruiting patients. The trial was first posted on 1/1/2013 and most recently edited on 9/23/2022. The clinical trial is enrolling 100 patients between 1 sites."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Cornell University - Human Metabolic Research Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Looking to learn more about my health condition and hope to help others to with the research done.
PatientReceived 1 prior treatment
~5 spots leftby Apr 2025