clinicaltrials.gov Identifier: NCT01408147.

No abstract

BackgroundGestational diabetes mellitus (GDM) contributes to the epidemic of diabetes and obesity in mothers and their offspring. The primary objective of this pilot study was to: 1) refine the GDM Management System (GooDMomS), a web-based pregnancy and postpartum behavioral intervention and 2) assess the feasibility of the intervention.MethodsIn phase 1, ten semi-structured interviews were conducted with women experiencing current or recent GDM mellitus GDM to garner pilot data on the web based intervention interface, content, and to solicit recommendations from women about refinements to enhance the GooDMomS intervention site. Interviews were audiotaped, transcribed and independently reviewed to identify major themes with Atlas.ti v7.0. In phase 2, a single-arm feasibility study was conducted and 23 participants were enrolled in the GooDMomS program. Participants received web lessons, self-tracking of weight and glucose, automated feedback and access to a message board for peer support. The primary outcome was feasibility, including recruitment and retention and acceptability. Secondary outcomes included the proportion of women whose gestational weight gain (GWG) was within the Institute of Medicine (IOM) guidelines and who were able to return to their pre-pregnancy weight after delivery.ResultsComments from semi-structured interviews focused on: 1) usability of the on-line self-monitoring diary and tracking system, 2) access to a safe, reliable social network for peer support and 3) ability of prenatal clinicians to access the on-line diary for clinical management. Overall, 21 (91 %) completed the pregnancy phase. 15/21 (71 %) of participants were within the Institute of Medicine (IOM) guidelines for GWG. Sixteen (70 %) completed the postpartum phase. 7/16 (43 %) and 9/16 (56 %) of participants returned to their pre-pregnancy weight at 6 and 30 weeks postpartum, respectively.ConclusionsThis study documents the feasibility of the GooDMomS program. The results can have implications for web technology in perinatal care and inform the current care paradigm for women with GDM. Findings are supportive of further research with recruitment of a larger sample of participants and comparison of the outcomes with the intervention and standard care.Trial registrationThe study was registered at ClinicalTrials.gov on May 15, 2012 under protocol no. NCT01600534.

IMPORTANCE Postpartum weight retention increases lifetime risk of obesity and related morbidity. Few effective interventions exist for multicultural, low-income women. OBJECTIVE To test whether an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) for low-income postpartum women could produce greater weight loss than the WIC program alone over 12 months. DESIGN, SETTING, AND PARTICIPANTS A 12-month, cluster randomized, assessor-blind, clinical trial enrolling 371 adult postpartum women at 12 clinics in WIC programs from the California central coast between July 2011 and May 2015 with data collection completed in May 2016.INTERVENTIONS Clinics were randomized to the WIC program (standard care group) or the WIC program plus a 12-month primarily internet-based weight loss program (intervention group), including a website with weekly lessons, web diary, instructional videos, computerized feedback, text messages, and monthly face-to-face groups at the WIC clinics. MAIN OUTCOMES AND MEASURESThe primary outcome was weight change over 12 months, based on measurements at baseline, 6 months, and 12 months. Secondary outcomes included proportion returning to preconception weight and changes in physical activity and diet.RESULTS Participants included 371 women (mean age, 28.1 years; Hispanic, 81.6%; mean weight above prepregnancy weight, 7.8 kg; mean months post partum, 5.2 months) randomized to the intervention group or standard care group; 89.2% of participants completed the study. The intervention group produced greater mean 12-month weight loss compared with the standard care group. More participants in the intervention group than the standard care group returned to preconception weight by 12 months. 12-mo Outcomes Standard Care Group (n=197) Intervention Group (n=174) Between-Group Difference (95% CI) P Value Mean weight change, kg −0.9 (−1.7 to −0.1) −3.2 (−4.1 to −2.4) 2.3 (1.1 to 3.5) <.001 At or below preconception weight, No. (%) 36 (18.6) 57 (32.8) 14.2 (4.7 to 23.5) <.001 Change in physical activity, mean (95% CI), min/d −7.2