A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly

Study Overview
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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.

Official Title
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A Multi-Component Behavioral Nutrition Intervention for Homebound Older Adults

Conditions
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Undernutrition

Intervention / Treatment
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* Behavioral: Nutrition Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition Intervention<br>The intervention group will receive a full nutrition assessment and a nutrition intervention. | Behavioral: Nutrition Intervention<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |