The MOM TO BE Study

NCT04273048 | Terminated

• 1 other identifier: 260113
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (2)

• Oocyte gene expression profile

  Oocyte gene expression

  8-12 weeks

• Follicular fluid content

  Follicular fluid content

  8-12 weeks

Study Arms (2)

Diet and Exercise

ACTIVE COMPARATOR

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; Other: Exercise Intervention - Group 1

Standard Care

NO INTERVENTION

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

Interventions

Diet Intervention - Group 1 OTHER

They will be provided with a Mediterranean diet plan.

Diet and Exercise

Exercise Intervention - Group 1 OTHER

They will be provided with an exercise plan to follow.

Diet and Exercise

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 25 - 45 kg/m2
• ≥ 21 years of age

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72203, United States

Location

Related Publications (1)

• 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.

  PMID: 34399856 DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: February 17, 2020
• Study Start: July 21, 2020
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)