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 Details — Status: Completed

Administrative data

• NCT number: NCT02567513
• Other study ID #: 090948
• Status: Completed
• Phase: N/A
• First received: October 1, 2015
• Last updated: October 5, 2015
• Start date: October 2009
• Est. completion date: July 2014

Study information

• Verified date: October 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Weight Loss

Intervention

Behavioral:
• Supplement Intervention
Supplements given twice/day, 5 days/week, for 24 weeks by research staff.
• Snack Intervention
Snacks given twice/day, 5 days/week for 24 weeks by research staff.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Agency for Healthcare Research and Quality (AHRQ)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total caloric intake during and between meals	Weighed intake methods both during and between meals were used to assess total caloric intake before and after intervention.	24 weeks	No