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The Effect of Nutrisystem Meal Provision on Weight

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ClinicalTrials.gov Identifier: NCT01252303
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : June 23, 2011
Sponsor:
Collaborator:
Nutrisystem, Inc.
Information provided by:
University of Kentucky

Tracking Information
First Submitted Date  ICMJE November 30, 2010
First Posted Date  ICMJE December 2, 2010
Last Update Posted Date June 23, 2011
Study Start Date  ICMJE January 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2010)
weight change [ Time Frame: 12 weeks ]
Amount of weight lost in the 12 week study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2010)
  • Blood pressure [ Time Frame: 12 weeks ]
    The change in blood pressure over the 12 weeks.
  • Fasting Blood Glucose [ Time Frame: 12 weeks ]
    Change in fasting blood glucose over the 12 weeks.
  • blood lipids [ Time Frame: 12 weeks ]
    Change in blood lipids over the 12 weeks.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Nutrisystem Meal Provision on Weight
Official Title  ICMJE 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.
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Nutrisystem
Nutrisystem meal replacements for 12 weeks
Other Name: Weight loss trial
Study Arms  ICMJE
  • Experimental: Nutrisystem
    Group will receive Nutrisystem meals in addition to the behavioral weight loss program.
    Intervention: Behavioral: Nutrisystem
  • Active Comparator: Control
    Group will receive a behavioral weight loss program only.
    Intervention: Behavioral: Nutrisystem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must (1) be age 25 to 65 years old; (2) have a BMI of > 30 and <45; (3) own a home computer with access to the Internet.

Exclusion Criteria:

  • Participants must not: (1) have a medical diagnosis of orthopedic or joint problems that may prohibit regular exercise; (2) endorse any of the first three items on the Physical Activity Readiness Questionnaire (PAR-Q): heart problems, chest pain, faintness or dizzy spells; (3) endorse any of the other items on the PAR-Q without a physician's consent; (4) have had a hospitalization for a psychiatric disorder within the last year; (5) have a history of anorexia or bulimia nervosa; (6) have a medical diagnosis of cancer or HIV with the exception of skin cancer; (7) have a diagnosis with a major psychiatric disorder (i.e. bipolar disorder or schizophrenia); (8) be pregnant, nursing, or planning to become pregnant within the study period; (9) be less than 9 months post-partum; (10) have a recent weight loss of > 10 pounds; (11) be using centrally-active medications, with the exception of alcohol and caffeine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01252303
Other Study ID Numbers  ICMJE 10-0639-F3R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kelly Webber, assistant professor, University of Kentucky
Study Sponsor  ICMJE University of Kentucky
Collaborators  ICMJE Nutrisystem, Inc.
Investigators  ICMJE
Principal Investigator: Kelly H Webber, PhD University of Kentucky
PRS Account University of Kentucky
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP