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Completed

NCT Number: NCT01197768

A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly

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.

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Key information

Conditions

Undernutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Caloric Intake

    Time frame: 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 outcomes

  1. Health services utilization, specifically hospitalization and re-hospitalization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Duke University
  • Mayo Clinic

Registry information

Official study title

A Multi-Component Behavioral Nutrition Intervention for Homebound Older Adults

Acronym: MCBNIHE

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 9, 2010
Registry last updated
Oct 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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