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Clinical Trials/NCT01197768
NCT01197768
Completed
Not Applicable

A Multi-Component Behavioral Nutrition Intervention for Homebound Older Adults

University of Alabama at Birmingham1 site in 1 country104 target enrollmentSeptember 2008
ConditionsUndernutrition

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Undernutrition
Sponsor
University of Alabama at Birmingham
Enrollment
104
Locations
1
Primary Endpoint
Caloric Intake
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
February 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie Locher, PhD

Principal Investigator

University of Alabama at Birmingham

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

Outcomes

Primary Outcomes

Caloric Intake

Time Frame: 2 and 8 months post-baseline

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 Outcomes

  • Health services utilization, specifically hospitalization and re-hospitalization(6 months from follow-up assessment)

Study Sites (1)

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