The MOM TO BE Study

Arkansas Children's Hospital Research Institute

Status: Terminated

Conditions: Infertility, Female

Treatments: Other: Diet Intervention - Group 1; Other: Exercise Intervention - Group 1

Study type: Interventional

Funder types: Other

Identifiers

NCT04273048

260113

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

14 participants in 2 patient groups

Diet and Exercise

Active Comparator group

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.

Treatment:

Other: Exercise Intervention - Group 1

Other: Diet Intervention - Group 1

Standard Care

No Intervention group

Description:

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