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A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly

NCT ID: NCT01197768

Last Updated: 2011-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Undernutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nutrition Intervention

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

Group Type EXPERIMENTAL

Nutrition Intervention

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Julie Locher, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F080428013

Identifier Type: -

Identifier Source: org_study_id