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

This study has been terminated.
(Difficult to recruit, very poor compliance with interventions)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01325805
First Posted: March 30, 2011
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ruth Bunker Lathi, Stanford University
  Purpose

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 Intervention
Obese Overweight Miscarriage Recurrent Pregnancy Loss Behavioral: Structured Weight Loss Program Behavioral: Routine Weight Loss Counseling

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ruth Bunker Lathi, Stanford University:

Primary Outcome Measures:
  • Term live birth rate [ Time Frame: 2.5 years ]

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

Enrollment: 7
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325805


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ruth Bunker Lathi Stanford University
  More Information

Additional Information:
Publications:
Practice Committee of tAmerican Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss. Fertil Steril. 2008 Nov;90(5 Suppl):S60. doi: 10.1016/j.fertnstert.2008.08.065.
Li TC, Makris M, Tomsu M, Tuckerman E, Laird S. Recurrent miscarriage: aetiology, management and prognosis. Hum Reprod Update. 2002 Sep-Oct;8(5):463-81. Review.
James PT. Obesity: the worldwide epidemic. Clin Dermatol. 2004 Jul-Aug;22(4):276-80. Review.
Shirazian T, Raghavan S. Obesity and pregnancy: implications and management strategies for providers. Mt Sinai J Med. 2009 Dec;76(6):539-45. doi: 10.1002/msj.20148. Review.
Rich-Edwards JW, Goldman MB, Willett WC, Hunter DJ, Stampfer MJ, Colditz GA, Manson JE. Adolescent body mass index and infertility caused by ovulatory disorder. Am J Obstet Gynecol. 1994 Jul;171(1):171-7.
Jensen MD. Medical management of obesity. Semin Gastrointest Dis. 1998 Oct;9(4):156-62. Review.
Bolúmar F, Olsen J, Rebagliato M, Sáez-Lloret I, Bisanti L. Body mass index and delayed conception: a European Multicenter Study on Infertility and Subfecundity. Am J Epidemiol. 2000 Jun 1;151(11):1072-9.
van der Steeg JW, Steures P, Eijkemans MJ, Habbema JD, Hompes PG, Burggraaff JM, Oosterhuis GJ, Bossuyt PM, van der Veen F, Mol BW. Obesity affects spontaneous pregnancy chances in subfertile, ovulatory women. Hum Reprod. 2008 Feb;23(2):324-8. Epub 2007 Dec 11.
Metwally M, Ong KJ, Ledger WL, Li TC. Does high body mass index increase the risk of miscarriage after spontaneous and assisted conception? A meta-analysis of the evidence. Fertil Steril. 2008 Sep;90(3):714-26. Epub 2008 Feb 6. Review.
Lashen H, Fear K, Sturdee DW. Obesity is associated with increased risk of first trimester and recurrent miscarriage: matched case-control study. Hum Reprod. 2004 Jul;19(7):1644-6. Epub 2004 May 13.
Wang JX, Davies MJ, Norman RJ. Obesity increases the risk of spontaneous abortion during infertility treatment. Obes Res. 2002 Jun;10(6):551-4.
Metwally M, Saravelos SH, Ledger WL, Li TC. Body mass index and risk of miscarriage in women with recurrent miscarriage. Fertil Steril. 2010 Jun;94(1):290-5. doi: 10.1016/j.fertnstert.2009.03.021. Epub 2009 May 12.
Clark AM, Thornley B, Tomlinson L, Galletley C, Norman RJ. Weight loss in obese infertile women results in improvement in reproductive outcome for all forms of fertility treatment. Hum Reprod. 1998 Jun;13(6):1502-5.

Responsible Party: Ruth Bunker Lathi, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01325805     History of Changes
Other Study ID Numbers: SU-03212011-7603
IRB Protocol Number 20001 ( Other Identifier: Stanford University )
First Submitted: March 23, 2011
First Posted: March 30, 2011
Last Update Posted: November 25, 2016
Last Verified: June 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ruth Bunker Lathi, Stanford University:
Miscarriage
Recurrent Pregnancy Loss
Obesity
Overweight
Diet

Additional relevant MeSH terms:
Overweight
Weight Loss
Abortion, Spontaneous
Fetal Death
Body Weight
Signs and Symptoms
Body Weight Changes
Pregnancy Complications
Death
Pathologic Processes


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