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

NCT01325805 | Terminated

• 2 other identifiers: SU-03212011-7603IRB Protocol Number 20001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese; Overweight; Miscarriage; Recurrent Pregnancy Loss

Keywords

Miscarriage; Recurrent Pregnancy Loss; Obesity; Overweight; Diet

Outcome Measures

Primary Outcomes (1)

• Term live birth rate

  2.5 years

Secondary Outcomes (9)

• 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

Study Arms (2)

Structured Weight Loss

EXPERIMENTAL

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

Routine Weight Loss Counseling

ACTIVE COMPARATOR

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

Behavioral: Routine Weight Loss Counseling

Interventions

Structured Weight Loss Program BEHAVIORAL

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.

Structured Weight Loss

Routine Weight Loss Counseling BEHAVIORAL

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

Routine Weight Loss Counseling

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (13)

• 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.

  PMID: 19007647 BACKGROUND

• 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. doi: 10.1093/humupd/8.5.463.

  PMID: 12398226 BACKGROUND

• James PT. Obesity: the worldwide epidemic. Clin Dermatol. 2004 Jul-Aug;22(4):276-80. doi: 10.1016/j.clindermatol.2004.01.010.

  PMID: 15475226 BACKGROUND

• 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.

  PMID: 20014418 BACKGROUND

• 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. doi: 10.1016/0002-9378(94)90465-0.

  PMID: 8030695 BACKGROUND

• Jensen MD. Medical management of obesity. Semin Gastrointest Dis. 1998 Oct;9(4):156-62.

  PMID: 9822077 BACKGROUND

• Bolumar F, Olsen J, Rebagliato M, Saez-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. doi: 10.1093/oxfordjournals.aje.a010150.

  PMID: 10873131 BACKGROUND

• 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. doi: 10.1093/humrep/dem371. Epub 2007 Dec 11.

  PMID: 18077317 BACKGROUND

• 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. doi: 10.1016/j.fertnstert.2007.07.1290. Epub 2008 Feb 6.

  PMID: 18068166 BACKGROUND

• 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. doi: 10.1093/humrep/deh277. Epub 2004 May 13.

  PMID: 15142995 BACKGROUND

• Wang JX, Davies MJ, Norman RJ. Obesity increases the risk of spontaneous abortion during infertility treatment. Obes Res. 2002 Jun;10(6):551-4. doi: 10.1038/oby.2002.74.

  PMID: 12055331 BACKGROUND

• 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.

  PMID: 19439294 BACKGROUND

• 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. doi: 10.1093/humrep/13.6.1502.

  PMID: 9688382 BACKGROUND

Related Links

• Stanford Fertility \& Reproductive Medicine Center

MeSH Terms

Conditions

Obesity; Overweight; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ruth Bunker Lathi

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 30, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)