BiometricsNCT01846169
Study to Improve Healthy Eating for At-Risk Older Adults
A study testing Food deliveries in people with Biometrics, run by Boston Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Biometrics
- What is being tested?
- Food deliveries
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Follows a special diet that cannot be accommodated, as ascertained by clinical judgment of the nurse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Biometrics
- Being tested
- Food deliveries
- Keywords
- food insecurity, older adults, nutrition, food deliveries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food deliveriesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| food deliveries | Experimental | After baseline screening, participants receive weekly or bi-weekly food deliveries and brief nutrition education. Receives: Behavioral: Food deliveries |
What is being measured
The primary outcome is the main question the study is designed to answer.
body composition
percent body fat
Measured: 6 months
BMI
Body mass index
Measured: 6 months
weight
total body weight in pounds
Measured: 6 months
blood pressure
systolic and diastolic blood pressure
Measured: 6 months
blood glucose
measurement of blood glucose
Measured: 6 months
Secondary outcomes (2)
nutritional risk
food frequency questionnaire assessing levels of food intake in pre-specified categories (e.g., fruits and vegetables)
Measured: 6 months
food insecurity
measurement of food insecurity as assessed by standard questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiometricsStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eileen O'Brien, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846169
- Sponsor's protocol ID
- HUN-12-2011-004
- Status last verified
- Aug 2014
- First submitted
- 1 May 2013
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating for At-Risk Older Adults (HERO)
- ClinicalTrials.gov ID
- NCT01846169
- Acronym / sponsor ID
- HUN-12-2011-004
- Conditions
- Biometrics
- Keywords
- food insecurity, older adults, nutrition, food deliveries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| food deliveries | Experimental | Behavioral: Food deliveriesAfter baseline screening, participants receive weekly or bi-weekly food deliveries and brief nutrition education. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Follows a special diet that cannot be accommodated, as ascertained by clinical judgment of the nurse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food deliveriesFrequency 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. | Behavioural | food deliveries |
Primary outcome
body composition
Time frame: 6 months
percent body fat
BMI
Time frame: 6 months
Body mass index
weight
Time frame: 6 months
total body weight in pounds
blood pressure
Time frame: 6 months
systolic and diastolic blood pressure
blood glucose
Time frame: 6 months
measurement of blood glucose
2 secondary outcomes
nutritional risk
Time frame: 6 months
food insecurity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
- AARP FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen O'Brien principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food deliveries in people with Biometrics, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body composition (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2014.