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

NCT02567513 | Completed

• 1 other identifier: 090948
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weight Loss

Keywords

food and fluid intake; nursing homes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Usual Care control group

NO INTERVENTION

Eligible, consented residents continue to receive usual care from nursing home staff and are independently monitored by trained research staff.

Supplement Intervention

EXPERIMENTAL

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.

Behavioral: Supplement Intervention

Snack Intervention

EXPERIMENTAL

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.

Behavioral: Snack Intervention

Interventions

Supplement Intervention BEHAVIORAL

Supplements given twice/day, 5 days/week, for 24 weeks by research staff.

Also known as: Experimental Supplement Intervention

Supplement Intervention

Snack Intervention BEHAVIORAL

Snacks given twice/day, 5 days/week for 24 weeks by research staff.

Also known as: Experimental Snack Intervention

Snack Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra F Simmons, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 5, 2015
• Study Start: October 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 6, 2015

Record last verified: 2015-10