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The MOM TO BE Study

Primary Purpose

Infertility, Female

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet Intervention - Group 1
Exercise Intervention - Group 1
Sponsored by
Arkansas Children's Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility, Female

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Arkansas Children's Nutrition CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Diet and Exercise

Standard Care

Arm Description

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

Outcomes

Primary Outcome Measures

Oocyte gene expression profile
Oocyte gene expression
Follicular fluid content
Follicular fluid content

Secondary Outcome Measures

Full Information

First Posted
November 13, 2019
Last Updated
March 26, 2023
Sponsor
Arkansas Children's Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04273048
Brief Title
The MOM TO BE Study
Official Title
A Dietary and Exercise Intervention in Overweight and Obese Women Undergoing Fertility Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diet and Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Group 2 = Standard: They will receive standard care from the Little Rock Fertility Center.
Intervention Type
Other
Intervention Name(s)
Diet Intervention - Group 1
Intervention Description
They will be provided with a Mediterranean diet plan.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention - Group 1
Intervention Description
They will be provided with an exercise plan to follow.
Primary Outcome Measure Information:
Title
Oocyte gene expression profile
Description
Oocyte gene expression
Time Frame
8-12 weeks
Title
Follicular fluid content
Description
Follicular fluid content
Time Frame
8-12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tonja C Nolen, MS
Phone
5013643309
Email
ACNCstudies@archildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey E Martinez, MS
Phone
5013643309
Email
ACNCstudies@archildrens.org
Facility Information:
Facility Name
Arkansas Children's Nutrition Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tonja C Nolen, MS
Phone
501-364-3309
Email
ACNCstudies@uams.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34399856
Citation
Fawcett K, Martinez A, Crimmins M, Sims C, Borsheim E, Andres A. Effect of a dietary and exercise intervention in women with overweight and obesity undergoing fertility treatments: protocol for a randomized controlled trial. BMC Nutr. 2021 Aug 17;7(1):51. doi: 10.1186/s40795-021-00454-y.
Results Reference
derived

Learn more about this trial

The MOM TO BE Study

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