Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT01252303
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2010-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Nutrisystem Meal Provision on Weight
Sponsor:
University of Kentucky
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: