CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 79 enrolled
Drug / intervention
Commercial Weight Loss Programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01785719
NCT01785719N/ACompleted
CompareCT.gov

Ultrasound Characterization of Ovarian Follicle Dynamics During Weight Loss

Cornell University·interventional·Posted Feb 7, 2013·Updated Feb 3, 2025

In Brief

A clinical study evaluating Commercial Weight Loss Program for Weight Loss and 3 related conditions. Completed, enrolled 79 participants across 1 site.

Detailed Summary

The objective of this study is to explore the effects of weight loss on body composition, metabolic status, reproductive hormones, and ovarian follicle development in obese women with regular menstrual cycles versus obese women with irregular menstrual cycles and/or polycystic ovary syndrome (PCOS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWeight Loss, Anovulation, Amenorrhea, Infertility
CountriesUnited States
CollaboratorsNutrisystem, Inc., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2013
Enrollment StartJan 1, 2013
Primary CompletionDec 21, 2023
TodayJul 2, 2026
Enrollment to primary: 11.0 yearsPosted 13.4 years ago

Interventions

Commercial Weight Loss Programbehavioral

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 Dietary Guidelines 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.