title: Feasibility of a brief, intensive weight loss intervention to improve reproductive outcomes in obese, subfertile women: a pilot study.
abstract: OBJECTIVE
  To evaluate the feasibility of a brief, intensive weight loss intervention (IWL) to improve reproductive outcomes in obese subfertile women.
  
  
  METHODS
  Pilot study of IWL versus standard-of-care nutrition counseling (SCN).
  
  
  METHODS
  Single-site, academic institution.
  
  
  METHODS
  Obese women (body mass index, 35-45 kg/m2) with anovulatory subfertility.
  
  
  METHODS
  Women were rigorously prescreened to rule out secondary causes of subfertility. Eligible women were randomized to IWL or SCN. IWL consisted of 12 weeks of very-low-energy diet (800 kcal/day) + 4 weeks of a low-calorie conventional food-based diet (CFD) to promote 15% weight loss. SCN consisted of 16 weeks of CFD to promote ≥5% weight loss. Women were transitioned to weight maintenance diets and referred back to reproductive endocrinology for ovulation induction.
  
  
  METHODS
  Feasibility of recruitment, randomization, intervention implementation, and retention.
  
  
  RESULTS
  Thirty-nine women were screened; 25 (64%) were eligible to participate, and 14 of those eligible (56%) agreed to be randomized, seven in each group. One withdrew from the IWL group and two from the SCN group. Percent weight loss was greater in the IWL group than in the SCN group (13% ± 5% vs. 4% ± 4%). Three of six women in the IWL group conceived and delivered term pregnancies. No pregnancies occurred in the SCN group.
  
  
  CONCLUSIONS
  After rigorous screening, 44% of eligible women completed the study. IWL was associated with greater percentage weight loss and improvements in insulin sensitivity.
  
  
  BACKGROUND
  NCT01894074.
authors.affiliation: Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan; Department of Nutritional Sciences, University of Michigan, Ann Arbor, Michigan. Electronic address: arothber@med.umich.edu.
authors.forename: Amy
authors.initials: A
authors.lastname: Rothberg
authors.affiliation: Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Michael
authors.initials: M
authors.lastname: Lanham
authors.affiliation: Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.
authors.forename: John
authors.initials: J
authors.lastname: Randolph
authors.affiliation: Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.
authors.forename: Christine
authors.initials: C
authors.lastname: Fowler
authors.affiliation: Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.
authors.forename: Nicole
authors.initials: N
authors.lastname: Miller
authors.affiliation: Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Smith
mesh_terms: D000328:Adult; D015992:Body Mass Index; D031204:Caloric Restriction; D005240:Feasibility Studies; D005260:Female; D005298:Fertility; D006801:Humans; D007247:Infertility, Female / Q000175:diagnosis / Q000209:etiology* / Q000503:physiopathology; D007333:Insulin Resistance; D008824:Michigan; D009765:Obesity / Q000150:complications / Q000175:diagnosis / Q000178:diet therapy* / Q000503:physiopathology; D010865:Pilot Projects; D060728:Reproductive Health; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss
keywords: Obesity; anovulatory; intensive dietary intervention; weight loss