The MOM TO BE Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2022-06-21

Brief Summary

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

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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.

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Diet and Exercise

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.

Group Type ACTIVE_COMPARATOR

Diet Intervention - Group 1

Intervention Type OTHER

They will be provided with a Mediterranean diet plan.

Exercise Intervention - Group 1

Intervention Type OTHER

They will be provided with an exercise plan to follow.

Standard Care

Group 2 = Standard: They will receive standard care from the Little Rock Fertility Center.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diet Intervention - Group 1

They will be provided with a Mediterranean diet plan.

Intervention Type OTHER

Exercise Intervention - Group 1

They will be provided with an exercise plan to follow.

Intervention Type OTHER

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).

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes