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

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supplement Intervention
Snack Intervention
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Weight Loss focused on measuring food and fluid intake, nursing homes

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Usual Care control group

    Supplement Intervention

    Snack Intervention

    Arm Description

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

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2015
    Last Updated
    October 5, 2015
    Sponsor
    Vanderbilt University
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02567513
    Brief Title
    Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial
    Official Title
    Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss
    Keywords
    food and fluid intake, nursing homes

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    154 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care control group
    Arm Type
    No Intervention
    Arm Description
    Eligible, consented residents continue to receive usual care from nursing home staff and are independently monitored by trained research staff.
    Arm Title
    Supplement Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Snack Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Supplement Intervention
    Other Intervention Name(s)
    Experimental Supplement Intervention
    Intervention Description
    Supplements given twice/day, 5 days/week, for 24 weeks by research staff.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Snack Intervention
    Other Intervention Name(s)
    Experimental Snack Intervention
    Intervention Description
    Snacks given twice/day, 5 days/week for 24 weeks by research staff.
    Primary Outcome Measure Information:
    Title
    Total caloric intake during and between meals
    Description
    Weighed intake methods both during and between meals were used to assess total caloric intake before and after intervention.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandra F Simmons, PhD
    Organizational Affiliation
    Vanderbilt University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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