The Effect of Nutrisystem Meal Provision on Weight
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nutrisystem
Intervention type(s): Behavioral
Intervention description(s): Nutrisystem meal replacements for 12 weeks
Other intervention name(s): Weight loss trial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity, weight loss, meal replacements