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

A Multi-Component Behavioral Nutrition Intervention for Homebound Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Undernutrition
• Intervention / Treatment: Behavioral: Nutrition Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 and 8 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months from follow-up assessment

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Mayo Clinic; Duke University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: September 7, 2010
• First Posted (Estimate): September 9, 2010

Study Record Updates

• Last Update Posted (Estimate): October 14, 2011
• Last Update Submitted That Met QC Criteria: October 12, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: F080428013