HypertensionNCT01033513
SOS Nutrition Project
An observational study of Hypertension and Hyperlipidemia, run by University of North Carolina, Charlotte.
Trial summary
Many older people experience hyperlipidemia and hypertension, but, to date, there is little information regarding whether or not medical nutrition therapy (MNT) or therapeutic meals have an independent or joint beneficial impact on older people with these diagnoses. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension, Hyperlipidemia
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- May 2003to 22 Sep 2006
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: See inclusion and exclusion criteria below.
Who may be able to join
- People were eligible for the study if they were 60 years old or older and: *were diagnosed by a physician with hyperlipidemia and/or hypertension
- had storage space for frozen and shelf-stable meals
- had the mental and physical capacity to safely store, prepare, and consume meals and benefit from MNT
- had their physician's permission to be included in the trial
- were willing/able to provide blood samples, stay on the regimen, maintain the healthcare/medication utilization diary, and answer questions about diet and quality of life
- were willing to stay on the their arm and consume meals and/or receive MNT if assigned to one of those arms
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- did not leave their town or city in a typical week unless it was for reasons that are acceptable under the Medicare definition of homebound
- did not plan to be away from home for more than two weeks during the intervention period
- were able to communicate (speak, read, write) in English and were able to understand and willing to complete the consent process for participation.
Who cannot join
- Individuals excluded from the study were those younger than age 60, or those without one of the qualifying diagnoses (hypertension or hyperlipidemia), and those who had any of the following characteristics:
- coronary artery bypass, diabetes, myocardial infarction within the 12 months prior to enrollment, renal insufficiency, major surgery in the 12 weeks prior to enrollment, unstable angina, uncompensated congestive heart failure, liver disease, pancreatic disease, current serious gastrointestinal disease (for example, colitis), or current cancer or other life-limiting diagnoses
- were unable to safely manage and consume frozen and shelf stable meals
- self-disclosed as having alcohol or drug abuse within the 24 months prior to enrollment
- were unable or unwilling to provide necessary biological material and other information required by the study
- had very high knowledge of dietary/lifestyle management issues required by the diagnosis, based on a knowledge questionnaire
Show all 9Show fewer
- indicated that they left their city or town in a typical week
- were employed full-time
- had significant food allergies or were unable to eat the food offered through the project because of religious or other restrictions.
About this study
Many older people experience hyperlipidemia and hypertension, but, to date, there is little information regarding whether or not medical nutrition therapy (MNT) or therapeutic meals have an independent or joint beneficial impact on older people with these diagnoses. This report describes a clinical trial in which the investigators directly examined these issues. Two key clinical outcome measures include changes in diastolic blood pressure and total fasting serum cholesterol. In addition to these clinical outcome measures the investigators collected health related quality of life data and data that permitted cost-effectiveness analyses.
The investigators hypothesized that MNT and therapeutic meals would each lead to lower total fasting serum cholesterol and lower diastolic blood pressure after the 52-week trial, in comparison to individuals who received standard support (commonly available literature on how to manage their disease). The investigators also hypothesized that MNT plus therapeutic meals would be especially beneficial because of their synergistic effects on the clinical outcomes. Although the investigators established no specific hypotheses regarding the potential impact of MNT or therapeutic meals on cost of care and quality adjusted life years, the investigators were interested in whether MNT or therapeutic meals would be associated with these two measures.
- Conditions
- Hypertension, Hyperlipidemia
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Literature Only (Control) | The participants on this arm served as the control group. Five types of literature were mailed to the participants in the literature only arm. A letter was included with the materials thanking participants for their participation, requesting that the participants read the literature, and encouraging them to contact the RDs with any questions. The Clinical Study Manager's telephone number was provided for questions about diet or lifestyle changes. The RDs documented all contacts with participants on a phone summary. Other than the delivery of literature and responses to specific questions asked by the participant or the participant's primary caregiver through telephone calls, the RDs had no further interaction with the participant until the conclusion of the participant's trial period. | |
| Meals Only | Participants in the meals only arm received a pre-intervention assessment (but no nutrition counseling). The RDs gave the participants in the meals only arm a phone number and encouraged them to phone with questions or problems, especially problems associated with the meals. Subsequently, the meals only participants received seven diagnosis-appropriate therapeutic meals a week, delivered once per week. The meals were specially designed to address the participants' medical diagnoses. They were developed using the ADA MNT protocols for caloric and nutrient content requirements for individuals with the specified diagnoses, in addition to meeting AoA Nutrition Program dietary requirements. The meals were provided primarily in frozen form. However, some shelf-stable and refrigerated components were also included. In conformance with AoA regulations, appropriate meals were also offered to the spouse of any participant receiving a therapeutic meal. | |
| MNT Only | The participants in this arm received MNT from the project RDs, who employed the Hyperlipidemia Medical Nutrition Therapy MNT Protocol, developed by ADA (2002). Because ADA had not finalized MNT protocols for hypertension, the RDs followed the protocol for hyperlipidemia for participants diagnosed with either hyperlipidemia or hypertension, with adjustments, as appropriate, to benefit those individuals who were diagnosed with hypertension.All MNT sessions were in the participants' homes, and if a caregiver was required for the individual to participate in the project, every effort was made to include this person in the MNT sessions. The MNT intervention took place over at least three sessions, and, in conformance with the ADA protocol, each participant received individualized counseling and education. | |
| Meals and MNT | The participants assigned to the MNT plus meals arm received both of the interventions, as described above. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startMay 2003
- Study completion22 Sep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Charlotte
- Sponsor type
- University, hospital or other
- Collaborators
- Administration on Aging, United States, Mecklenburg County Department of Social Services
- Investigators
- William J McAuley, PhD, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033513
- Sponsor's protocol ID
- AoA90AM2665
- Status last verified
- Oct 2017
- First submitted
- 15 Dec 2009
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOS Nutrition Project
- ClinicalTrials.gov ID
- NCT01033513
- Acronym / sponsor ID
- AoA90AM2665
- Conditions
- Hypertension, Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Collaborators
- Administration on Aging, United States, Mecklenburg County Department of Social Services
- Study start
- May 2003
- Study completion
- 22 Sep 2006 (actual)
- First posted
- 16 Dec 2009 (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.
Many older people experience hyperlipidemia and hypertension, but, to date, there is little information regarding whether or not medical nutrition therapy (MNT) or therapeutic meals have an independent or joint beneficial impact on older people with these diagnoses. This report describes a clinical trial in which the investigators directly examined these issues. Two key clinical outcome measures include changes in diastolic blood pressure and total fasting serum cholesterol. In addition to these clinical outcome measures the investigators collected health related quality of life data and data that permitted cost-effectiveness analyses.
The investigators hypothesized that MNT and therapeutic meals would each lead to lower total fasting serum cholesterol and lower diastolic blood pressure after the 52-week trial, in comparison to individuals who received standard support (commonly available literature on how to manage their disease). The investigators also hypothesized that MNT plus therapeutic meals would be especially beneficial because of their synergistic effects on the clinical outcomes. Although the investigators established no specific hypotheses regarding the potential impact of MNT or therapeutic meals on cost of care and quality adjusted life years, the investigators were interested in whether MNT or therapeutic meals would be associated with these two measures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Literature Only (Control) | – | –The participants on this arm served as the control group. Five types of literature were mailed to the participants in the literature only arm. A letter was included with the materials thanking participants for their participation, requesting that the participants read the literature, and encouraging them to contact the RDs with any questions. The Clinical Study Manager's telephone number was provided for questions about diet or lifestyle changes. The RDs documented all contacts with participants on a phone summary. Other than the delivery of literature and responses to specific questions asked by the participant or the participant's primary caregiver through telephone calls, the RDs had no further interaction with the participant until the conclusion of the participant's trial period. |
| Meals Only | – | –Participants in the meals only arm received a pre-intervention assessment (but no nutrition counseling). The RDs gave the participants in the meals only arm a phone number and encouraged them to phone with questions or problems, especially problems associated with the meals. Subsequently, the meals only participants received seven diagnosis-appropriate therapeutic meals a week, delivered once per week. The meals were specially designed to address the participants' medical diagnoses. They were developed using the ADA MNT protocols for caloric and nutrient content requirements for individuals with the specified diagnoses, in addition to meeting AoA Nutrition Program dietary requirements. The meals were provided primarily in frozen form. However, some shelf-stable and refrigerated components were also included. In conformance with AoA regulations, appropriate meals were also offered to the spouse of any participant receiving a therapeutic meal. |
| MNT Only | – | –The participants in this arm received MNT from the project RDs, who employed the Hyperlipidemia Medical Nutrition Therapy MNT Protocol, developed by ADA (2002). Because ADA had not finalized MNT protocols for hypertension, the RDs followed the protocol for hyperlipidemia for participants diagnosed with either hyperlipidemia or hypertension, with adjustments, as appropriate, to benefit those individuals who were diagnosed with hypertension.All MNT sessions were in the participants' homes, and if a caregiver was required for the individual to participate in the project, every effort was made to include this person in the MNT sessions. The MNT intervention took place over at least three sessions, and, in conformance with the ADA protocol, each participant received individualized counseling and education. |
| Meals and MNT | – | –The participants assigned to the MNT plus meals arm received both of the interventions, as described above. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See inclusion and exclusion criteria below.
Key inclusion criteria (9 listed)
- People were eligible for the study if they were 60 years old or older and: *were diagnosed by a physician with hyperlipidemia and/or hypertension
Key exclusion criteria (9 listed)
- Individuals excluded from the study were those younger than age 60, or those without one of the qualifying diagnoses (hypertension or hyperlipidemia), and those who had any of the following characteristics:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 31 Oct 2017.
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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.
William J McAuley, PhD principal investigator
George Mason University
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Hyperlipidemia, run by University of North Carolina, Charlotte.
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 9 inclusion and 9 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 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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 31 Oct 2017.