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Table 1 Schedule of enrollment, interventions, and assessments at specific time points

From: Effect of a dietary and exercise intervention in women with overweight and obesity undergoing fertility treatments: protocol for a randomized controlled trial

 

Study Period

 

Staff Member

Pre-study Screening/ Consent

Baseline

Allocation

 

Post-Allocation

Time Point

  

Visit 1

Visit 2

Visit 3

Retrieval

RECRUITMENT/ENROLLMENT

 Eligibility Screen

Research Team Member

x

    

 Medical Record Release and Medical Release for Exercise

Medical Provider/Arkansas Fertility and Gynecology

x

    

 Informed Consent

Research Team Member

 

x

   

 Allocation of Treatment Groups

Clinical Coordinator or PI

  

x

  

 Compensation

Research Team Member

 

x

 

x

x

INTERVENTION

 Diet, Exercise, Coaching*

Research Team Member

 

x

x1

x1

x

 Standard of Care

Arkansas Fertility and Gynecology

 

x

x

x

x

ASSESSMENTS

 Demographic and Contact Information

Research Team Member

 

x

 

x

 

 Medical History

Research Team Member

 

x

 

x

 

 Vitals and Anthropometrics

Research Team Member

 

x

 

x

 

 Fasted blood collection

Phlebotomist

 

x

 

x

 

 Urine sample collection

Participant

 

x

 

x

 

 Stool sample collection

Participant

 

x

 

x

 

 Body Composition

Research Team Member

 

x

 

x

 

 Resting Energy Expenditure

Research Team Member

 

x

 

x

 

 Activity Energy Expenditure

Participant Worn Monitor

 

x

 

x

 

 Fitness Testing

Exercise Physiologist

 

x

 

x

 

 3 Day Food Records

Nutritionist

 

x

   

 Coaching

Research Team Member

  

x1

x1

 

 Physical Activity Questionnaire

Participant Self-Assessment

 

x

 

x

 

 Cohen’s Perceived Stress Scale

Participant Self-Assessment

 

x

 

x

 

 Beck Depression Inventory-II

Participant Self-Assessment

 

x

 

x

 

 Oocyte and Follicular Fluid Retrieval

Arkansas Fertility and Gynecology

    

x

 Hormonal Panel and Birth Outcomes

Arkansas Fertility and Gynecology

    

x

 Feasibility Qualitative Interviews

Research Team Member

    

x1

  1. x- All Participants, x1-Only the intervention group, * Diet, Exercise, and Coaching will take place after Visit 2 of study, intervention will last 8–12 weeks depending on oocyte retrieval process