- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01846169
Study to Improve Healthy Eating for At-Risk Older Adults
August 21, 2014 updated by: Boston Medical Center
Healthy Eating for At-Risk Older Adults (HERO)
This application, funded by the American Association of Retired Persons(AARP) Foundation, is to implement the Healthy Eating for at Risk Older Adults (HERO) initiative.
This initiative will address barriers of affordability, and reduced mobility by providing older adults with nutritious foods that are usually difficult to purchase due to high cost; delivering needed foods to individuals in their homes; tailoring food delivery frequency based on level of food insecurity; and offering basic nutrition education.
Study Overview
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 55 years old or older
- if member of Boston Medical Center's Elders Living at Home Program: Not currently homeless and expect to live at current residence or in the area for next 6 months
- if NOT member of Boston Medical Center's Elders Living at Home Program: Not currently homeless, live at public housing development, and plan to live there for at least next 6 months
- Able to understand, speak and read English
Exclusion Criteria:
- Follows a special diet that cannot be accommodated, as ascertained by clinical judgment of the nurse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: food deliveries
After baseline screening, participants receive weekly or bi-weekly food deliveries and brief nutrition education.
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Frequency of food deliveries is based on level of food insecurity at baseline (i.e., more food insecurity receives more frequent food deliveries).
Deliveries are tailored to the diet of the client (e.g., consist of soft foods if participant has trouble chewing; has more fruits and vegetables if that was a food category the participant at less of at baseline).
The brief nutrition education is a review of basic nutrition concepts and healthy eating ideas.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: 6 months
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Body mass index
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6 months
|
|
body composition
Time Frame: 6 months
|
percent body fat
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6 months
|
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weight
Time Frame: 6 months
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total body weight in pounds
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6 months
|
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blood pressure
Time Frame: 6 months
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systolic and diastolic blood pressure
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6 months
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blood glucose
Time Frame: 6 months
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measurement of blood glucose
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
nutritional risk
Time Frame: 6 months
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food frequency questionnaire assessing levels of food intake in pre-specified categories (e.g., fruits and vegetables)
|
6 months
|
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food insecurity
Time Frame: 6 months
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measurement of food insecurity as assessed by standard questionnaire
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eileen O'Brien, Boston Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
May 1, 2013
First Submitted That Met QC Criteria
May 1, 2013
First Posted (Estimate)
May 3, 2013
Study Record Updates
Last Update Posted (Estimate)
August 25, 2014
Last Update Submitted That Met QC Criteria
August 21, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- HUN-12-2011-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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