A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly

Undernutrition Clinical Trial

— MCBNIHE  

Official title:

A Multi-Component Behavioral Nutrition Intervention for Homebound Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197768
• Other study ID #: F080428013
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: October 12, 2011
• Start date: September 2008
• Est. completion date: February 2011

Study information

• Verified date: October 2011
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Duke University, Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No