Pregnancy Outcomes in Overweight Women With Prior Miscarriages Following a Structured Weight Loss Program Versus Weight-Loss Counseling

The purpose of this study is to investigate the impact of a structured weight loss program
versus traditional weight-loss counseling on pregnancy outcomes in women with recurrent
pregnancy loss. The study protocol is as follows:

1. Patients will be notified of study via flyer inserted into patient chart at initial
clinic visit, physician referral or Stanford website. Patients expressing interest will
have their charts reviewed to confirm that they meet all enrollment criteria. Potential
subjects will then be contacted via phone and verbal consent to participate obtained.

2. The participant will then have an office visit for consent signing and randomization. A
formal weight will be obtained, the Beck Depression Inventory will be administered by
Penny Donnelly, a self-administered questionnaire will be completed, and a basic
laboratory evaluation, including a fasting lipid panel, alanine aminotransferase (ALT),
fasting glucose and insulin levels, 2-hour glucose tolerance test, hemoglobin A1c and
CRP will be preformed.

3. The patients will then be randomized to traditional weight loss counseling (control
group) or to the structured weight loss program (study group). Patients will be
instructed to discontinue attempts at conception.

4. Those patients randomized to the control group will receive the ACOG Patient Education
pamphlets on obesity.

5. Those patients randomized to the study group will have a formal evaluation and
counseling by Dr. Sun Kim, a medical endocrinologist specializing in weight management.
They will then be enrolled in a structured weight loss program.

6. For all patients, a 3-month follow-up office visit will be scheduled. At this visit, a
formal weight will be obtained, the Beck Depression Inventory will be re-administered
by Penny Donnelly, a self-administered questionnaire will be completed, and a follow-up
laboratory evaluation, including a fasting lipid panel, alanine aminotransferase (ALT),
fasting glucose and insulin levels, 2-hour glucose tolerance test, hemoglobin A1c and
CRP will be preformed. Patients will be informed that they may now being attempts to
conceive.

7. Patients randomized to the study group will continue in the structured weight loss
program for 6 months.

8. Six months after enrollment, all patients will have a telephone interview in which a
close-out questionnaire will be administered and a final, self-reported weight will be
obtained.

9. Primary and secondary outcomes will be followed for 2.5 years after date of enrollment
for all patients.

Inclusion Criteria:

1. Unexplained recurrent pregnancy loss (2 or more prior miscarriages)

2. BMI >=25 kg/m2

3. Prepared to take 3 months ¡®time out¡± from attempting to conceive

4. Ability to attend a one hour initial, then 30 minute follow-up nutrition/monitoring
session - once per week for one month, then every other week for 2 months, then once
then once per month for 3 months.

Exclusion Criteria:

1. Age >=40 years

2. Diagnosis of Type 1 or Type 2 Diabetes as defined by a fasting glucose >=126, or 2
hour glucose >=200 by a 75 gram oral glucose challenge

3. Presence of an endocrine condition such as hyperprolactinemia, Cushing¡-s syndrome or
untreated thyroid disease (defined as a TSH outside of the laboratory determined
normal range)

4. Desire to continue attempts to conceive for the duration of the program

5. History of bariatric surgery

6. Use of over-the-counter or prescribed weight loss medications with the exception of
metformin

7. Enrollment in another clinical trial (excluding surveys)