A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly

Not Applicable

Completed

• Conditions: Undernutrition
• Interventions: Behavioral: Nutrition Intervention

• Registration Number: NCT01197768
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-09
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-12
• Last Update Posted: 2011-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition Intervention	Nutrition Intervention	The intervention group will receive a full nutrition assessment and a nutrition intervention.

Primary Outcome Measures

Name	Time	Method
Caloric Intake	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 Outcome Measures

Name	Time	Method
Health services utilization, specifically hospitalization and re-hospitalization	6 months from follow-up assessment	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States