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Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial

Weight Loss Clinical Trial

Official title:
Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial

Clinical Trial Summary

Low oral food and fluid intake and unintentional weight loss are common problems among long-stay nursing home (NH) residents and are associated with adverse, costly clinical outcomes. This study will use a controlled, intervention design to determine the cost-effectiveness of oral liquid nutrition supplements with an alternative nutrition intervention that offers NH residents a choice between supplements and other foods and fluids (i.e., snacks) between meals in a group of 200 residents across 4 NH sites. Residents with an order for supplementation will be included in this study and randomized into one of three groups: (1) usual care control; (2) oral liquid nutrition supplementation intervention; or (3) choice intervention. The usual care control group will continue to receive standard NH care for supplement or snack delivery. Research staff will provide the same supplements used by the NH (group two) or a choice between supplements and other foods and fluids (group three) twice daily, five days per week, for 24 weeks and document the daily costs of intervention implementation when also providing a prompting protocol known to improve intake and enhance independence in eating. Based on extensive preliminary data, it is anticipated that both groups two and three will require significantly more staff time than usual care (group one). Thus, the labor costs of these interventions will be documented and compared to effectiveness measures. Effectiveness measures include the following resident outcomes: improvements in total daily caloric intake, weight, nutrition and hydration status and quality of life. These outcomes will be independently monitored for all three groups across 24-weeks by trained research staff using standardized, validated protocols.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02567513
Study type Interventional
Source Vanderbilt University
Contact
Status Completed
Phase N/A
Start date October 2009
Completion date July 2014
View Details
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