ObesityNCT01252303
The Effect of Nutrisystem Meal Provision on Weight
A study testing Nutrisystem in people with Obesity, run by University of Kentucky at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nutrisystem
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky
Lexington, Kentucky, 40506-0054
About this study
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.
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Nutrisystem
- Keywords
- Obesity, weight loss, meal replacements
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutrisystemBehavioural
Also called Weight loss trial
Nutrisystem meal replacements for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nutrisystem | Experimental | Group will receive Nutrisystem meals in addition to the behavioral weight loss program. Receives: Behavioral: Nutrisystem |
| Control | Active comparator | Group will receive a behavioral weight loss program only. Receives: Behavioral: Nutrisystem |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
Amount of weight lost in the 12 week study.
Measured: 12 weeks
Secondary outcomes (3)
Blood pressure
The change in blood pressure over the 12 weeks.
Measured: 12 weeks
Fasting Blood Glucose
Change in fasting blood glucose over the 12 weeks.
Measured: 12 weeks
blood lipids
Change in blood lipids over the 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrisystem, Inc.
- Investigators
- Kelly H Webber, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252303
- Sponsor's protocol ID
- 10-0639-F3R
- Status last verified
- Jun 2011
- First submitted
- 30 Nov 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01252303
- Acronym / sponsor ID
- 10-0639-F3R
- Conditions
- Obesity
- Keywords
- Obesity, weight loss, meal replacements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- Nutrisystem, Inc.
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrisystem | Experimental | Behavioral: NutrisystemGroup will receive Nutrisystem meals in addition to the behavioral weight loss program. |
| Control | Active comparator | Behavioral: NutrisystemGroup will receive a behavioral weight loss program only. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutrisystemAlso: Weight loss trialNutrisystem meal replacements for 12 weeks | Behavioural | Control, Nutrisystem |
Primary outcome
weight change
Time frame: 12 weeks
Amount of weight lost in the 12 week study.
3 secondary outcomes
Blood pressure
Time frame: 12 weeks
Fasting Blood Glucose
Time frame: 12 weeks
blood lipids
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly H Webber, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrisystem in people with Obesity, run by University of Kentucky at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight change (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.