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A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly (MCBNIHE)

This study has been completed.
Sponsor:
Collaborators:
Duke University
Mayo Clinic
Information provided by (Responsible Party):
Julie Locher, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01197768
First received: September 2, 2010
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Undernutrition
 Behavioral: Nutrition Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Component Behavioral Nutrition Intervention for Homebound Older Adults

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Caloric Intake [ Time Frame: 2 and 8 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months from follow-up assessment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 104
Study Start Date: September 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutrition Intervention
The intervention group will receive a full nutrition assessment and a nutrition intervention.
 Behavioral: Nutrition Intervention
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.
No Intervention: Control
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. at least 65 years of age
  2. homebound (based upon Medicare's definition of homebound status)
  3. able to communicate or have a caregiver who is able to communicate
  4. living in a private residence
  5. experiencing either an acute illness or chronic condition
  6. not consuming enough calories to maintain body weight or weight loss of > 5% over past 6 months (if known)

Exclusion Criteria:

  1. significantly cognitive impaired (MMSE < 24 if living alone or MMSE < 15 if living with caregiver) (if known)
  2. terminally ill
  3. any cancer diagnosis within the past five years (melanoma excluded)
  4. end-stage renal disease
  5. gastric or enteral tube-feedings
  6. dependent on a ventilator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197768

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Duke University
Mayo Clinic
  More Information

No publications provided

Responsible Party: Julie Locher, PhD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01197768     History of Changes
Other Study ID Numbers: F080428013
Study First Received: September 2, 2010
Last Updated: October 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 21, 2013