Efficacy of a Structured Weight Loss Program in Overweight Women With a History of Recurrent Pregnancy Loss

Not Applicable

Terminated

• Conditions: Obese; Overweight; Miscarriage; Recurrent Pregnancy Loss
• Interventions: Behavioral: Routine Weight Loss Counseling; Behavioral: Structured Weight Loss Program

• Registration Number: NCT01325805
• Lead Sponsor: Stanford University

Brief Summary

Overweight and obesity has been associated with a number of adverse pregnancy outcomes in women of reproductive age, including infertility and early pregnancy loss. Recent data suggests that overweight and obese patients are also at increased risk of recurrent pregnancy loss (RPL), a devastating condition that affects 1% of the fertile population.

The investigators propose a prospective, randomized controlled trial in which overweight and obese patients with unexplained recurrent pregnancy loss are enrolled in a structured, 6 month, weight loss program or provided routine counseling regarding the importance of weight loss. Pregnancy outcomes will then be followed to assess miscarriage rates. Metabolic outcomes, such as lipid and glucose profiles, will also be evaluated.

Detailed Description

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-30
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Weight Loss Counseling	Routine Weight Loss Counseling	Patients are counseled by a physicians about the impact of maternal weight on fertility and pregnancy outcomes.
Structured Weight Loss	Structured Weight Loss Program	Women randomized to this arm will meet with a registered dietician regularly for review of calorie recommendations and food diary. As well as regular clinic visits to measure patients weight.

Primary Outcome Measures

Name	Time	Method
Term live birth rate	2.5 years

Secondary Outcome Measures

Name	Time	Method
Changes in hemoglobin A1c levels	3 months
Weight loss - goal for weight loss defined as 5 percent of enrollment body weight lost	6 months
Changes in high density lipoprotein levels	3 months
Changes in fasting insulin levels	3 months
Changes in fasting glucose levels	3 months
Changes in triglyceride levels	3 months
Changes in alanine aminotransferase (ALT) levels	3 months
Changes in postprandial insulin levels	3 months
Changes in postprandial glucose levels	3 months

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States