Clinical trial NCT01033513: SOS Nutrition Project
Official title: SOS Nutrition Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: University of North Carolina, Charlotte
Sponsor class: OTHER
Collaborators: name: Administration on Aging, United States
name: Mecklenburg County Department of Social Services
First posted: 2009-12-16
Enrollment: 320
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: See inclusion and exclusion criteria below.

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: George Mason University
name: William J McAuley, PhD
role: PRINCIPAL_INVESTIGATOR
References: