SOS Nutrition Project
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|ClinicalTrials.gov Identifier: NCT01033513|
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : October 31, 2017
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||320 participants|
|Official Title:||SOS Nutrition Project|
|Study Start Date :||May 2003|
|Study Completion Date :||September 22, 2006|
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.
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033513
|Principal Investigator:||William J McAuley, PhD||George Mason University|