The Effect of Nutrisystem Meal Provision on Weight
Status: | Archived |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | January 2011 |
End Date: | April 2011 |
The Effect of a Behavioral Weight Loss Program With Nutrisystem Meal Provision on Change in Weight, Fasting Blood Glucose, Cholesterol, and Blood Pressure Over 12 Weeks.
The study is to determine the effect of a behavioral weight loss program supplemented with
Nutrisystem meal replacements on weight, blood pressure, fasting blood glucose, and blood
lipids levels over 12 weeks.
Specific Aim 1- Compare two programs, a standard Internet weight loss program and an
Internet behavioral weight loss program, enhanced with Nutrisystem meal provision, on their
effectiveness in producing weight loss and improvements in fasting blood glucose, blood
pressure, and blood lipid levels over 12 weeks.
Specific Aim 2- Determine the usage and acceptability of the two programs.
Overall Hypothesis:
The Internet program with Nutrisystem meal provision will produce greater improvements in
participant's health (weight, blood pressure, blood lipids, and fasting blood glucose) than
the standard Internet program alone at 12 weeks. The acceptability and usage of each
program will directly correlate with weight loss in participants.
Recruitment Methods Participants will be recruited through advertisements in local
newspapers. Randomization A two-group randomized design will be used. After meeting all
exclusion/inclusion criteria, completion of all study measurements, and provision of written
consent, individuals will be randomized to one of the two study groups: (1) the standard
Internet behavioral weight loss program alone or (2) the standard Internet program plus
Nutrisystem meal provision.
Timeline and Milestones Recruitment advertisements for the study will be placed in
mid-December. Participants who meet all inclusion/exclusion criteria will be invited to a
study information session the first week of January.
Delivery Phase (Jan.-April 2011) The delivery phase will entail: (1) conducting study
information sessions; (2) baseline assessments; (3) conducting the 12-week Intervention; (4)
12-week assessments. Dr. Webber will conduct study information sessions for qualified
participants during the first week of January. Interested participants will then be asked
to sign consent forms, fill out motivation questionnaires, and to schedule appointments at
the Clinical Research Center (CRC) at the University of Kentucky for baseline assessments of
height, weight, waist circumference, blood pressure, fasting blood glucose and blood lipids.
Once measurements at the CRC are taken, participants will be randomized to study group. At
baseline each group will receive a 2-hour weight loss group session with a registered
dietitian. The weight loss session will include presentation of information on exercise and
dietary recommendations, an overview of energy balance, and instructions for
self-monitoring, good dietary practices, exercise safety recommendations, and orientation to
the study website.
Both groups will be given password protected access to a standard Internet program. The
website will include 12 weekly lessons based on the Diabetes Prevention Program (DPP), a
message board feature, a link to a personal self-monitoring diary, a library of links to
diet, exercise, and behavioral resources available on the web, and a weekly weight loss tip.
The Nutrisystem group will receive 2 weeks of meals at the baseline 2-hour session. They
will be asked to return every two weeks to the clinic to pick up Nutrisystem meals.
Evaluation Phase (May-Oct. 2011) The evaluation phase of the project will entail: (1) data
entry, cleaning and analysis; (2) final report preparation; (3) manuscript preparation.
We found this trial at
1
site
Click here to add this to my saved trials