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

This study is currently recruiting participants.
Verified June 2011 by Stanford University
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01325805
First received: March 23, 2011
Last updated: June 13, 2011
Last verified: June 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Term live birth rate [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight loss - goal for weight loss defined as 5 percent of enrollment body weight lost [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in triglyceride levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in high density lipoprotein levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in alanine aminotransferase (ALT) levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in fasting insulin levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in postprandial insulin levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in fasting glucose levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in postprandial glucose levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in hemoglobin A1c levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Structured Weight Loss 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 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

Ages Eligible for Study:   18 Years to 39 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325805

Contacts
Contact: Jamie Masie, MD (650) 498-7408 jamiem1@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Jamie Masie, MD     650-498-7408     jamiem1@stanford.edu    
Principal Investigator: Ruth Bunker Lathi            
Sub-Investigator: Jamie Massie            
Sub-Investigator: Sun Hee Kim            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ruth Bunker Lathi Stanford University
  More Information

Additional Information:
Website dedicated to women's health clinical research at Stanford.  This link exits the ClinicalTrials.gov site
Healthy People 2010  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Ruth Bunker Lathi, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01325805     History of Changes
Other Study ID Numbers: SU-03212011-7603, IRB Protocol Number 20001
Study First Received: March 23, 2011
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Miscarriage
Recurrent Pregnancy Loss
Obesity
Overweight
Diet

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

ClinicalTrials.gov processed this record on May 16, 2013