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Completed

NCT Number: NCT02567513

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supplement Intervention

Behavioral

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

Other names: Experimental Supplement Intervention

Snack Intervention

Behavioral

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

Other names: Experimental Snack Intervention

Primary outcomes

  1. Total caloric intake during and between meals

    Time frame: 24 weeks

    Weighed intake methods both during and between meals were used to assess total caloric intake before and after intervention.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 5, 2015
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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