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

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ClinicalTrials.gov Identifier: NCT01325805
Recruitment Status : Terminated (Difficult to recruit, very poor compliance with interventions)
First Posted : March 30, 2011
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Ruth Bunker Lathi, Stanford University

March 23, 2011
March 30, 2011
November 25, 2016
December 2010
December 2013   (Final data collection date for primary outcome measure)
Term live birth rate [ Time Frame: 2.5 years ]
Same as current
Complete list of historical versions of study NCT01325805 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of a Structured Weight Loss Program in Overweight Women With a History of Recurrent Pregnancy Loss
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

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.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Obese
  • Overweight
  • Miscarriage
  • Recurrent Pregnancy 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.
  • Behavioral: Routine Weight Loss Counseling
    Participants randomized to the routine weight loss counseling group will receive the ACOG Patient Education pamphlets on obesity.
  • 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.
    Intervention: Behavioral: Structured Weight Loss Program
  • Active Comparator: Routine Weight Loss Counseling
    Patients are counseled by a physicians about the impact of maternal weight on fertility and pregnancy outcomes.
    Intervention: Behavioral: Routine Weight Loss Counseling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
30
December 2013
December 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years to 39 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01325805
SU-03212011-7603
IRB Protocol Number 20001 ( Other Identifier: Stanford University )
No
Not Provided
Plan to Share IPD: No
Ruth Bunker Lathi, Stanford University
Stanford University
Not Provided
Principal Investigator: Ruth Bunker Lathi Stanford University
Stanford University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP