Combined financial incentives and behavioral weight management to enhance adherence with gestational weight gain guidelines: a randomized controlled trial.

BACKGROUND: Excessive gestational weight gain, particularly among overweight and obese women, is associated with adverse perinatal outcomes. Current interventions to limit gestational weight gain have achieved only modest success. OBJECTIVE: We sought to improve adherence to gestational weight gain guidelines with a dual intervention of financial incentives and antenatal behavioral weight management. STUDY DESIGN: This was a prospective randomized controlled trial at a single academic medical center in which women were assigned randomly to the intervention group or standard care. The primary outcome was adherence to gestational weight gain guidelines. Secondary outcomes included total gestational weight gain, mode of delivery, birthweight, neonatal intensive care unit admission, and development of gestational diabetes mellitus and hypertensive disorders of pregnancy. RESULTS: A total of 136 women were assigned randomly, with data available for analysis of 124 women. Gestational weight gain within the Institutes of Medicine guidelines was similar (30% vs 29%) in the intervention and standard care groups, respectively. There were no statistically significant differences in total gestational weight gain or perinatal outcomes. There was a nonstatistically significant decrease in macrosomia in the intervention compared with standard care condition. CONCLUSION: A combined financial incentive and behavioral weight management intervention did not improve adherence to gestational weight gain guidelines. Modifications to the intervention may achieve improved results.

A protocol for the Hamilton Rating Scale for Depression: Item scoring rules, Rater training, and outcome accuracy with data on its application in a clinical trial.

BACKGROUND: We present a fully articulated protocol for the Hamilton Rating Scale for Depression (HAM-D), including item scoring rules, rater training procedures, and a data management algorithm to increase accuracy of scores prior to outcome analyses. The latter involves identifying potentially inaccurate scores as interviews with discrepancies between two independent raters on the basis of either scores >=5-point difference) or meeting threshold for depression recurrence status, a long-term treatment outcome with public health significance. Discrepancies are resolved by assigning two new raters, identifying items with disagreement per an algorithm, and reaching consensus on the most accurate scores for those items. METHODS: These methods were applied in a clinical trial where the primary outcome was the Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder version (SIGH-SAD), which includes the 21-item HAM-D and 8 items assessing atypical symptoms. 177 seasonally depressed adult patients were enrolled and interviewed at 10 time points across treatment and the 2-year followup interval for a total of 1589 completed interviews with 1535 (96.6%) archived. RESULTS: Inter-rater reliability ranged from ICCs of .923-.967. Only 86 (5.6%) interviews met criteria for a between-rater discrepancy. HAM-D items "Depressed Mood", "Work and Activities", "Middle Insomnia", and "Hypochondriasis" and Atypical items "Fatigability" and "Hypersomnia" contributed most to discrepancies. LIMITATIONS: Generalizability beyond well-trained, experienced raters in a clinical trial is unknown. CONCLUSIONS: Researchers might want to consider adopting this protocol in part or full. Clinicians might want to tailor it to their needs.