The Effect of Nutrisystem Meal Provision on Weight

This study has been completed.
Sponsor:
Collaborator:
Nutrisystem, Inc.
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT01252303
First received: November 30, 2010
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Nutrisystem

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • weight change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Amount of weight lost in the 12 week study.


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change in blood pressure over the 12 weeks.

  • Fasting Blood Glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in fasting blood glucose over the 12 weeks.

  • blood lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in blood lipids over the 12 weeks.


Enrollment: 50
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutrisystem
Group will receive Nutrisystem meals in addition to the behavioral weight loss program.
Behavioral: Nutrisystem
Nutrisystem meal replacements for 12 weeks
Other Name: Weight loss trial
Active Comparator: Control
Group will receive a behavioral weight loss program only.
Behavioral: Nutrisystem
Nutrisystem meal replacements for 12 weeks
Other Name: Weight loss trial

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252303

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506-0054
Sponsors and Collaborators
University of Kentucky
Nutrisystem, Inc.
Investigators
Principal Investigator: Kelly H Webber, PhD University of Kentucky
  More Information

No publications provided

Responsible Party: Kelly Webber, assistant professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01252303     History of Changes
Other Study ID Numbers: 10-0639-F3R
Study First Received: November 30, 2010
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Obesity, weight loss, meal replacements

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014