A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly

NCT01197768 | Completed

• 1 other identifier: F080428013
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Undernutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Health services utilization, specifically hospitalization and re-hospitalization

  6 months from follow-up assessment

Study Arms (2)

Nutrition Intervention

EXPERIMENTAL

The intervention group will receive a full nutrition assessment and a nutrition intervention.

Behavioral: Nutrition Intervention

Control

NO INTERVENTION

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.

Interventions

Nutrition Intervention BEHAVIORAL

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.

Nutrition Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Duke University: collaborator
• Mayo Clinic: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 9, 2010
• Study Start: September 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 14, 2011

Record last verified: 2011-10

Locations

US (1)