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

Sponsor

Stanford University (Other)

Overall Status

Terminated

CT.gov ID

NCT01325805

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obese Overweight Miscarriage Recurrent Pregnancy Loss	Behavioral: Structured Weight Loss Program Behavioral: Routine Weight Loss Counseling	N/A

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:

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.
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.
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.
Those patients randomized to the control group will receive the ACOG Patient Education pamphlets on obesity.
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.
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.
Patients randomized to the study group will continue in the structured weight loss program for 6 months.
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.
Primary and secondary outcomes will be followed for 2.5 years after date of enrollment for all patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pregnancy Outcomes in Overweight and Obese Women With a History of Recurrent Pregnancy Loss Randomized to a Structured Weight Loss Program Versus Routine Weight-Loss Counseling: A Pilot Study

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Structured Weight Loss 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.	Behavioral: Structured Weight Loss Program Those patients randomized to the structured weight loss group will have a formal evaluation and counseling a medical endocrinologist specializing in weight management. The structured weight loss program will consist of meeting with a dietician who will guide them on following a hypocaloric diet with a calorie deficit of 750kcal/day. The weight loss goal will be to lose 1-1.5 pounds/week. The participants will receive teaching utilizing the American Diabetes Association Exchange Lists and will receive sample meal plans. In addition, participants will be seen by the dietitian once a week for a month, then every 2 weeks for 2 months, then once per month for 3 months. Patients randomized to the study group will continue in the structured weight loss program for 6 months.
Active Comparator: Routine Weight Loss Counseling Patients are counseled by a physicians about the impact of maternal weight on fertility and pregnancy outcomes.	Behavioral: Routine Weight Loss Counseling Participants randomized to the routine weight loss counseling group will receive the ACOG Patient Education pamphlets on obesity.

Arm

Intervention/Treatment

Experimental: Structured Weight Loss

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.

Behavioral: Structured Weight Loss Program

Those patients randomized to the structured weight loss group will have a formal evaluation and counseling a medical endocrinologist specializing in weight management. The structured weight loss program will consist of meeting with a dietician who will guide them on following a hypocaloric diet with a calorie deficit of 750kcal/day. The weight loss goal will be to lose 1-1.5 pounds/week. The participants will receive teaching utilizing the American Diabetes Association Exchange Lists and will receive sample meal plans. In addition, participants will be seen by the dietitian once a week for a month, then every 2 weeks for 2 months, then once per month for 3 months. Patients randomized to the study group will continue in the structured weight loss program for 6 months.

Active Comparator: Routine Weight Loss Counseling

Patients are counseled by a physicians about the impact of maternal weight on fertility and pregnancy outcomes.

Behavioral: Routine Weight Loss Counseling

Participants randomized to the routine weight loss counseling group will receive the ACOG Patient Education pamphlets on obesity.

Outcome Measures

Primary Outcome Measures

Term live birth rate [2.5 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Unexplained recurrent pregnancy loss (2 or more prior miscarriages)
BMI >=25 kg/m2
Prepared to take 3 months ¡®time out¡± from attempting to conceive
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:

Age >=40 years
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
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)
Desire to continue attempts to conceive for the duration of the program
History of bariatric surgery
Use of over-the-counter or prescribed weight loss medications with the exception of metformin
Enrollment in another clinical trial (excluding surveys)