The Effect of Nutrisystem Meal Provision on Weight

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

Tracking Information

• First Submitted Date: November 30, 2010
• First Posted Date: December 2, 2010
• Last Update Posted Date: June 23, 2011
• Study Start Date: January 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 1, 2010)

weight change [ Time Frame: 12 weeks ]

Amount of weight lost in the 12 week study.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Nutrisystem Meal Provision on Weight
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obesity

Intervention

Behavioral: Nutrisystem

Nutrisystem meal replacements for 12 weeks

Other Name: Weight loss trial

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 1, 2010): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01252303
• Other Study ID Numbers: 10-0639-F3R
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kelly Webber, assistant professor, University of Kentucky
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Kentucky
• Original Study Sponsor: Same as current
• Collaborators: Nutrisystem, Inc.

Investigators

• Principal Investigator: Kelly H Webber, PhD; University of Kentucky

• PRS Account: University of Kentucky
• Verification Date: June 2011