Amy Rothberg1, Michael Lanham2, John Randolph2, Christine Fowler3, Nicole Miller3, Yolanda Smith2. 1. 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. 2. Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan. 3. Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.
Abstract
OBJECTIVE: To evaluate the feasibility of a brief, intensive weight loss intervention (IWL) to improve reproductive outcomes in obese subfertile women. DESIGN: Pilot study of IWL versus standard-of-care nutrition counseling (SCN). SETTING: Single-site, academic institution. PATIENT(S): Obese women (body mass index, 35-45 kg/m2) with anovulatory subfertility. INTERVENTION(S): 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. MAIN OUTCOME MEASURE(S): Feasibility of recruitment, randomization, intervention implementation, and retention. RESULT(S): 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. CONCLUSION(S): After rigorous screening, 44% of eligible women completed the study. IWL was associated with greater percentage weight loss and improvements in insulin sensitivity. CLINICAL TRIAL REGISTRATION: NCT01894074.
RCT Entities:
OBJECTIVE: To evaluate the feasibility of a brief, intensive weight loss intervention (IWL) to improve reproductive outcomes in obese subfertilewomen. DESIGN: Pilot study of IWL versus standard-of-care nutrition counseling (SCN). SETTING: Single-site, academic institution. PATIENT(S): Obesewomen (body mass index, 35-45 kg/m2) with anovulatory subfertility. INTERVENTION(S): 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. MAIN OUTCOME MEASURE(S): Feasibility of recruitment, randomization, intervention implementation, and retention. RESULT(S): 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. CONCLUSION(S): After rigorous screening, 44% of eligible women completed the study. IWL was associated with greater percentage weight loss and improvements in insulin sensitivity. CLINICAL TRIAL REGISTRATION: NCT01894074.
Authors: Sarah Price; Alison Nankervis; Michael Permezel; Luke Prendergast; Priya Sumithran; Joseph Proietto Journal: Trials Date: 2018-04-24 Impact factor: 2.279