The MOM TO BE Study

Study Overview
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Brief Summary
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This research study is about the effects of diet and exercise in women undergoing fertility treatment.

Detailed Description
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This study will randomize women who are undergoing fertility treatment and put them either in an intervention group or standard care. This study should help us learn if diet and exercise changes oocytes gene expression and follicular fluid content.

Official Title
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A Dietary and Exercise Intervention in Overweight and Obese Women Undergoing Fertility Treatment

Conditions
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Infertility, Female

Intervention / Treatment
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* Other: Diet Intervention - Group 1
* Other: Exercise Intervention - Group 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 25 - 45 kg/m2 ≥ 21 years of age Exclusion Criteria: Pre-existing conditions (e.g. sexual transmitted diseases) that will affect the outcomes of the study as determined by the principal investigator Current use of recreational drugs, tobacco, or alcohol Food allergies, intolerances or preferences which would interfere with compliance to the meal plan Contraindications to exercise Already meeting the physical activity guidelines (150 min moderate activity/week or 75 minutes of vigorous activity/week with resistance exercise on 2 or more days/week).

Ages Eligible for Study
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Minimum Age: 21 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This research will last up to 12 weeks. The participant will attend two research study visits and will be asked to donate oocytes and follicular fluid to the study team during their oocyte retrieval procedures. They will be randomized (like flipping a coin) to either a standard of care group or an intervention group. If they are in the intervention group, they will also be asked to follow a Mediterranean diet (all meals will be shipped to their home weekly) and exercise at least 3 times a week at a gym or at their house. If they are in the control group, they will follow the normal fertility clinic procedures.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet and Exercise<br>Group 1 = Diet Intervention group: They will be asked to follow a personalized diet during study period and record what they eat. The meal plan for this study is Mediterranean style and nutritionally complete for 8 to 12 weeks or until oocyte retrieval procedure. Exercise Intervention: Exercise 3 times/week at a gym of their choice or at home for 8 to 12 weeks or until oocyte retrieval procedure. Exercises will be light intensity and short duration at first and will gradually increase to moderate intensity and longer duration during the first 3 weeks. They will also be encouraged to walk an average 10,000 steps per day and wear a pedometer to monitor progress. | Other: Diet Intervention - Group 1<br>* They will be provided with a Mediterranean diet plan.<br>Other: Exercise Intervention - Group 1<br>* They will be provided with an exercise plan to follow.<br>|
| No Intervention: Standard Care<br>Group 2 = Standard: They will receive standard care from the Little Rock Fertility Center. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oocyte gene expression profile | Oocyte gene expression | 8-12 weeks | 
| Follicular fluid content | Follicular fluid content | 8-12 weeks |