CompletedNot Applicable

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

United States20 participantsStarted 2022-05-23

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Females * Age 18-40 years * Overweight or class I-III obesity (BMI 25-45 kg/m2) * Free of major psychiatric illnesses * Electing to start the Sprintec (norgestimate/ethinyl estradiol 0.25mg/35mcg) COC * Using non-hormonal forms of contraception: copper intrauterine device (Paragard), male condoms, tubal ligation, partner vasectomy, withdrawal/natural family planning, spermicide, abstinence, or other NHCs as determined by the investigators Exclusion Criteria: * Diabetes * Use of medications thought to affect body weight, energy intake, glycemic parameters, or estrogen (i.e. systemic glucocorticoids, stimulants, weight loss pharmacotherapy, metformin) * History of weight loss surgery * History of polycystic ovarian syndrome * History of congenital adrenal hyperplasia * Use of a different COC or hormonal contraception method within the past 3 months * Planning pregnancy * Planning to stop contraceptive within the next 6 months * Planning to change diet or join a weight loss program or research study within the next 6 months * Recent therapeutic abortion or miscarriage in the past 1 month if fetal gestational age \<10 weeks, or 3 months if fetal gestational age \>10 weeks * Pregnancy with delivery in the past 6 months * Currently lactating * People with pregnancy potential who were assigned female at birth and either currently using or planning to use gender-affirming hormone therapy in the next 6 months * Use of other forms of reproductive hormones such …

What they're measuring

Number of Premenopausal Women With Overweight/Obesity Who Initiated a COC vs. Continued NHC Use, Enrolled and Remained in This Study, and Completed Outcome Measures

Timeframe: Baseline, Month 6

Trial details

NCT IDNCT05061472

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-23

Results submitted2024-06-11