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The MOM TO BE Study

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04273048
Enrollment
14
Registered
2020-02-17
Start date
2020-07-21
Completion date
2022-06-21
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

Brief summary

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

Detailed description

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.

Interventions

OTHERDiet Intervention - Group 1

They will be provided with a Mediterranean diet plan.

They will be provided with an exercise plan to follow.

Sponsors

Arkansas Children's Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Oocyte gene expression profile8-12 weeksOocyte gene expression
Follicular fluid content8-12 weeksFollicular fluid content

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026