A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly (MCBNIHE)

This study has been completed.

Sponsor:

Collaborators:

Duke University

Mayo Clinic

Information provided by (Responsible Party):

Julie Locher, PhD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT01197768

First received: September 2, 2010

Last updated: October 12, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 2, 2010
Last Updated Date	October 12, 2011
Start Date ^ICMJE	September 2008
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 7, 2010)	Caloric Intake [ Time Frame: 2 and 8 months post-baseline ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01197768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 22, 2011)	Health services utilization, specifically hospitalization and re-hospitalization [ Time Frame: 6 months from follow-up assessment ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE (submitted: September 7, 2010)	Hospitalization and Re-hospitalization [ Time Frame: 6 months from follow-up assessment ] [ Designated as safety issue: No ] 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.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly
Official Title ^ICMJE	A Multi-Component Behavioral Nutrition Intervention for Homebound Older Adults
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Undernutrition
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Nutrition Intervention The intervention group will receive a full nutrition assessment and a nutrition intervention. Intervention: Behavioral: Nutrition Intervention No Intervention: 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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	104
Completion Date	February 2011
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	65 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01197768
Other Study ID Numbers ^ICMJE	F080428013
Has Data Monitoring Committee	Not Provided
Responsible Party	Julie Locher, PhD, University of Alabama at Birmingham
Study Sponsor ^ICMJE	University of Alabama at Birmingham
Collaborators ^ICMJE	Duke University Mayo Clinic
Investigators ^ICMJE	Not Provided
Information Provided By	University of Alabama at Birmingham
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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