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

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Behavioral: Snack Intervention; Behavioral: Supplement Intervention

• Registration Number: NCT02567513
• Lead Sponsor: Vanderbilt University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-10
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Long-stay nursing home residents,
• capable of oral food and fluid intake,
• physician or dietitian order for caloric supplementation.

Exclusion Criteria

• Short-stay nursing home residents (rehabilitation),
• feeding tube,
• hospice care.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Snack Intervention	Snack Intervention	Residents are offered a variety of snack options (foods and fluids, including supplement) consistent with prescribed orders twice per day (morning and afternoon), five days per week, for 24 consecutive weeks by trained research personnel. Research staff also provide the appropriate level and amount of assistance to encourage consumption.
Supplement Intervention	Supplement Intervention	Residents are offered a variety of supplement types and flavors consistent with prescribed orders twice per day (morning and afternoon), five days per week, for 24 consecutive weeks by trained research personnel. Research staff also provide the appropriate level and amount of assistance to encourage consumption.

Primary Outcome Measures

Name	Time	Method
Total caloric intake during and between meals	24 weeks	Weighed intake methods both during and between meals were used to assess total caloric intake before and after intervention.