SOS Nutrition Project

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
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.

Exclusion criteria

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
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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Charlotte

Other

Collaborators

Administration on Aging, United States
Mecklenburg County Department of Social Services

Registry information

Important dates

Study start: 2003
Study completion: 2006
First posted: Dec 16, 2009
Registry last updated: Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed