Undernutrition
Conditions
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.
Interventions
BEHAVIORALNutrition 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.
Sponsors
Duke University
Mayo Clinic
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caloric Intake | 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
| Measure | Time frame | Description |
|---|---|---|
| Health services utilization, specifically hospitalization and re-hospitalization | 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. |
Countries
United States
Outcome results
None listed