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A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity

NCT05061472 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-12-11

Study results available
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Summary

Approximately 15 million women of reproductive age women in the United States have overweight or obesity and use the combined estrogen and progestin oral contraceptive pill (COC). Although many women report weight gain as a side effect of COCs, a conclusive link between COC use and weight gain has not been established. This investigation will address a major gap in the literature by prospectively evaluating the influence of initiating a COC versus non-hormonal contraceptives (NHCs) on weight, body composition, eating behaviors, and appetite in pre-menopausal women with overweight or obesity. Aim 1 will assess the feasibility of recruiting and retaining a racially/ethnically diverse group of women with overweight and obesity while Aim 2 will explore changes in body weight, body composition, and cardiometabolic risks in these women; Aim 3 will explore changes in dietary and macronutrient energy intake, eating behaviors, and appetite in this subset of women. This research will help the investigators understand the extent to which COCs are associated with weight gain and help guide medical providers in counseling women with overweight and obesity on appropriate contraceptive methods.

Conditions

  • Contraceptive Usage
  • Overweight or Obesity
  • Body Weight Changes
  • Appetitive Behavior
  • Eating Behavior

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Adnin Zaman, MD · University of Colorado, Denver

  • Victoria A Catenacci, MD · University of Colorado, Denver

  • Elizabeth A Thomas, MD · University of Colorado, Denver

  • Aaron Lazorwitz, MD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2023-08-23
Completion
2023-08-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05061472 on ClinicalTrials.gov