A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly (MCBNIHE)
Primary Purpose
Undernutrition
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Undernutrition
Eligibility Criteria
Inclusion Criteria:
- at least 65 years of age
- homebound (based upon Medicare's definition of homebound status)
- able to communicate or have a caregiver who is able to communicate
- living in a private residence
- experiencing either an acute illness or chronic condition
- not consuming enough calories to maintain body weight or weight loss of > 5% over past 6 months (if known)
Exclusion Criteria:
- significantly cognitive impaired (MMSE < 24 if living alone or MMSE < 15 if living with caregiver) (if known)
- terminally ill
- any cancer diagnosis within the past five years (melanoma excluded)
- end-stage renal disease
- gastric or enteral tube-feedings
- dependent on a ventilator
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutrition Intervention
Control
Arm Description
The intervention group will receive a full nutrition assessment and a nutrition intervention.
This group will receive the nutrition assessment but no intervention from a Registered Dietician. If participant appears to be in danger due to BMI or Caloric intake status, their primary care physician will be notified.
Outcomes
Primary Outcome Measures
Caloric Intake
At each of the data collection points, (3) 24 hour Food Recalls will be collected and measured against each other. Participants who receive the intervention are hypothesized to increase their caloric intake post-baseline.
Secondary Outcome Measures
Health services utilization, specifically hospitalization and re-hospitalization
Patients receiving the intervention are hypothesized to have lower rates of hospitalization and re-hospitalization due to increased caloric intake and a reduced rate of physical decline.
Full Information
NCT ID
NCT01197768
First Posted
September 2, 2010
Last Updated
October 12, 2011
Sponsor
University of Alabama at Birmingham
Collaborators
Duke University, Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT01197768
Brief Title
A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly
Acronym
MCBNIHE
Official Title
A Multi-Component Behavioral Nutrition Intervention for Homebound Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Duke University, Mayo Clinic
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and feasibility of a multi-level self-management intervention to improve nutritional intake in a group of homebound older adults (HOAs) who are at especially high risk for undernutrition. The study will be guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory and will use a prospective randomized controlled design to estimate whether individually tailored counseling focusing on social and behavioral aspects of eating results in increased caloric intake and improved nutrition-related health outcomes in a sample of 104 HOAs. The investigators hypothesize that intervention at these levels will improve caloric intake and indirectly improve health outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nutrition Intervention
Arm Type
Experimental
Arm Description
The intervention group will receive a full nutrition assessment and a nutrition intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive the nutrition assessment but no intervention from a Registered Dietician. If participant appears to be in danger due to BMI or Caloric intake status, their primary care physician will be notified.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Intervention
Intervention Description
Participants randomized to the intervention group receive a comprehensive nutrition assessment and a in-home intervention with follow-up calls from a Registered Dietician who will addresses their risk for becoming under-nourished at multiple levels.
Primary Outcome Measure Information:
Title
Caloric Intake
Description
At each of the data collection points, (3) 24 hour Food Recalls will be collected and measured against each other. Participants who receive the intervention are hypothesized to increase their caloric intake post-baseline.
Time Frame
2 and 8 months post-baseline
Secondary Outcome Measure Information:
Title
Health services utilization, specifically hospitalization and re-hospitalization
Description
Patients receiving the intervention are hypothesized to have lower rates of hospitalization and re-hospitalization due to increased caloric intake and a reduced rate of physical decline.
Time Frame
6 months from follow-up assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least 65 years of age
homebound (based upon Medicare's definition of homebound status)
able to communicate or have a caregiver who is able to communicate
living in a private residence
experiencing either an acute illness or chronic condition
not consuming enough calories to maintain body weight or weight loss of > 5% over past 6 months (if known)
Exclusion Criteria:
significantly cognitive impaired (MMSE < 24 if living alone or MMSE < 15 if living with caregiver) (if known)
terminally ill
any cancer diagnosis within the past five years (melanoma excluded)
end-stage renal disease
gastric or enteral tube-feedings
dependent on a ventilator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
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A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly
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