Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02567513
Enrollment
154
Registered
2015-10-05
Start date
2009-10-31
Completion date
2014-07-31
Last updated
2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

Keywords

food and fluid intake, nursing homes

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.

Interventions

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

BEHAVIORALSnack Intervention

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

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Total caloric intake during and between meals24 weeksWeighed intake methods both during and between meals were used to assess total caloric intake before and after intervention.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026