Association Between the Menstrual Cycle and Weight Loss

Study Overview
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Brief Summary
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This is a research study to look at the association between weight loss and the menstrual cycle in healthy, overweight, premenopausal women. Participants will be asked to follow a reduced-calorie diet and exercise plan for 3 months.

Detailed Description
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Two different reduced calorie diet and exercise plans will be compared. One plan changes diet and exercise prescription with the phases of the menstrual cycle, while the other is a standard reduced calorie diet and exercise plan based on MyPyramid.gov website.

Official Title
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Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Reduced calorie diet and exercise plan
* Behavioral: Different reduced calorie diet and exercise plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy females between the ages of 18-40 (inclusive) BMI between 26.5-35.4 kg/m² (inclusive) Regular menstrual cycle (28 ± 3 days) Weight stable (within ± 3-kg) 2 months prior to study inclusion Must use barrier contraception (e.g. male/female condom) for the study's duration Must be willing to follow the prescribed diet/exercise plan for the study's duration Exclusion Criteria: On hormonal contraceptives or any other daily use of medications which can make the subject unsuitable for inclusion in the study. Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.) Restrictions against participating in cardiovascular exercise and strength training Any condition, which in the opinion of the investigator makes the subject unsuitable for inclusion in the study. Women who are pregnant, lactating, or planning to become pregnant during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle | Behavioral: Reduced calorie diet and exercise plan<br>* Participants will receive written diet and exercise instructions to follow for the duration of the study.<br>|
| Active Comparator: Group B<br>Different reduced calorie diet and exercise plan based on MyPyramid.gov website | Behavioral: Different reduced calorie diet and exercise plan<br>* Participants will receive written diet and exercise instructions to follow for the duration of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist Circumference |  | 3 months |