OverweightNCT00674180
Data Analysis of a Managed Care Weight Reduction Trial
An observational study of Overweight and Obesity, run by Albert Einstein College of Medicine.
Trial summary
This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in 2001 that evaluated the costs and effects of incremental components of a weight-loss program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Workbook, Computer Intervention and Staff Consultation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 588 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jan 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants were recruited from an HMO's patient population and from New Hyde Park, NY.
Who may be able to join
- BMI of more than 25 (or a BMI of 24 or more plus 1 cardiovascular risk factor), and the willingness to follow the study protocol, which included a refundable $100 deposit
Who cannot join
- Intention to move beyond commuting distance in the next 12 months,
- Medical conditions that would interfere with study participation,
- Unwillingness to follow the study protocol.
About this study
This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in 2001 that evaluated the costs and effects of incremental components of a weight-loss program. Data analysis will involve cross-sectional and predictive analyses and may include: regression analyses to determine predictors of weight loss and cardiovascular risk, correlations between weight reduction strategies and biological indices, and interactions between biomarkers of inflammation and traditional cardiovascular risk factors. This data will also be available for economic modeling.
Read the detailed description
This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in 2001. Using a 3-arm, 12-month randomized clinical trial, Wylie-Rosett et al. evaluated the costs and effects of incremental components of a weight-loss program. The study included 588 individuals (BMI> 25 kg/m2) in a freestanding health maintenance organization and achieved an 81% completion rate. The intervention used a cognitive behavioral approach for tailoring lifestyle modification goals. The incremental levels of interventions included a) a workbook alone, b) the addition of computerized tailoring using onsite computer kiosks with touch screen monitors, and c) the addition of both computers and staff consultations. For the increasing levels of intervention intensity, the mean 12-month weight losses were 2.2, 4.7, and 7.4 pounds, with the respective cost per participant being $12.33, $41.99, and $133.74. The decreases in mean BMIs for these respective intervention levels were 0.4, 0.9, and 1.2. All groups reported a decrease in energy and fat intake and an increase in blocks walked (p<.01). Intervention variables that correlated with weight loss included more computer logons, achieving computer-selected goals, more self-monitoring, increased walking, and decreased energy and fat intake, as well as higher attendance in staff consultation group sessions for that treatment condition. Weight loss correlated with decreases in fasting glucose and blood pressure. Wylie-Rosett et al. (2001) concluded that, in a weight-loss program, computers can facilitate selecting behavioral change goals. More frequent usage resulted in greater weight loss, and staff counseling to augment the computer intervention achieved the most weight loss. The purpose of this study will be secondary analysis of the data collected in the original MODELS study.
- Conditions
- Overweight, Obesity
- Being tested
- Workbook, Computer Intervention, Staff Consultation
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorkbookBehavioural
The workbook developed as a do-it-yourself program in which participants completed self-help sheets that guided them to sections of the workbook most salient to their needs.
Computer InterventionBehavioural
The computer intervention was provided using a network system that included a file server plus 5 multimedia computers with touch screens. The expert software program was written to guide participants in using the workbook and tail behavioral goals based on their prior computer use and the answers they provided on baseline questionnaires. The three primary paths in the computer addressed nutrition, fitness, and psychobehavioral content.
Staff ConsultationBehavioural
The staff consultation component included 6 closed-group workshop sessions and up to 18 telephone or face-to-face consultations with a registered dietician and/or a cognitive behavioral therapist. The workshop curriculum focused on specific activities and assignments in the workbook, and it encouraged use of the computer to identify problems and issues.
| Study group | Role | What they receive |
|---|---|---|
| 1 | a workbook alone Receives: Behavioral: Workbook | |
| 2 | a workbook alone and the addition of computerized tailoring using onsite computer kiosks with touch screen monitors Receives: Behavioral: Workbook; Behavioral: Computer Intervention | |
| 3 | a workbook, the addition of computerized tailoring using onsite computer kiosks with touch screen monitors, and staff consultations. Receives: Behavioral: Workbook; Behavioral: Computer Intervention; Behavioral: Staff Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 1 year
Secondary outcomes (1)
diabetes and cardiovascular risk
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2008
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Wylie-Rosett, Albert Einstein College of Medicine
- Investigators
- Judith Wylie-Rosett, EdD, Principal investigator, Albert Einstein College of MedicineCharles Swencionis, PhD, Study chair, Yeshiva University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674180
- Sponsor's protocol ID
- 2008-833
- Status last verified
- Jan 2020
- First submitted
- 5 May 2008
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Wylie-Rosett J, Swencionis C, Ginsberg M, Cimino C, Wassertheil-Smoller S, Caban A, Segal-Isaacson CJ, Martin T, Lewis J. Computerized weight loss intervention optimizes staff time: the clinical and cost results of a controlled clinical trial conducted in a managed care setting. J Am Diet Assoc. 2001 Oct;101(10):1155-62; quiz 1163-4. doi: 10.1016/s0002-8223(01)00284-x.
PubMed 11678486Swencionis C, Wylie-Rosett J, Lent MR, Ginsberg M, Cimino C, Wassertheil-Smoller S, Caban A, Segal-Isaacson CJ. Weight change, psychological well-being, and vitality in adults participating in a cognitive-behavioral weight loss program. Health Psychol. 2013 Apr;32(4):439-46. doi: 10.1037/a0029186. Epub 2012 Aug 13.
PubMed 22888821
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Analysis of a Managed Care Weight Reduction Trial
- ClinicalTrials.gov ID
- NCT00674180
- Acronym / sponsor ID
- 2008-833
- Conditions
- Overweight, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 May 2008 (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.
This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in 2001 that evaluated the costs and effects of incremental components of a weight-loss program. Data analysis will involve cross-sectional and predictive analyses and may include: regression analyses to determine predictors of weight loss and cardiovascular risk, correlations between weight reduction strategies and biological indices, and interactions between biomarkers of inflammation and traditional cardiovascular risk factors. This data will also be available for economic modeling.
Detailed description
This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in 2001. Using a 3-arm, 12-month randomized clinical trial, Wylie-Rosett et al. evaluated the costs and effects of incremental components of a weight-loss program. The study included 588 individuals (BMI> 25 kg/m2) in a freestanding health maintenance organization and achieved an 81% completion rate. The intervention used a cognitive behavioral approach for tailoring lifestyle modification goals. The incremental levels of interventions included a) a workbook alone, b) the addition of computerized tailoring using onsite computer kiosks with touch screen monitors, and c) the addition of both computers and staff consultations. For the increasing levels of intervention intensity, the mean 12-month weight losses were 2.2, 4.7, and 7.4 pounds, with the respective cost per participant being $12.33, $41.99, and $133.74. The decreases in mean BMIs for these respective intervention levels were 0.4, 0.9, and 1.2. All groups reported a decrease in energy and fat intake and an increase in blocks walked (p<.01). Intervention variables that correlated with weight loss included more computer logons, achieving computer-selected goals, more self-monitoring, increased walking, and decreased energy and fat intake, as well as higher attendance in staff consultation group sessions for that treatment condition. Weight loss correlated with decreases in fasting glucose and blood pressure. Wylie-Rosett et al. (2001) concluded that, in a weight-loss program, computers can facilitate selecting behavioral change goals. More frequent usage resulted in greater weight loss, and staff counseling to augment the computer intervention achieved the most weight loss. The purpose of this study will be secondary analysis of the data collected in the original MODELS study.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Workbooka workbook alone |
| 2 | – | Behavioral: Workbook, Behavioral: Computer Interventiona workbook alone and the addition of computerized tailoring using onsite computer kiosks with touch screen monitors |
| 3 | – | Behavioral: Workbook, Behavioral: Computer Intervention, Behavioral: Staff Consultationa workbook, the addition of computerized tailoring using onsite computer kiosks with touch screen monitors, and staff consultations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants were recruited from an HMO's patient population and from New Hyde Park, NY.
Key inclusion criteria (1 listed)
- BMI of more than 25 (or a BMI of 24 or more plus 1 cardiovascular risk factor), and the willingness to follow the study protocol, which included a refundable $100 deposit
Key exclusion criteria (3 listed)
- Intention to move beyond commuting distance in the next 12 months,
- Medical conditions that would interfere with study participation,
- Unwillingness to follow the study protocol.
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 |
|---|---|---|
| WorkbookThe workbook developed as a do-it-yourself program in which participants completed self-help sheets that guided them to sections of the workbook most salient to their needs. | Behavioural | 1, 2, 3 |
| Computer InterventionThe computer intervention was provided using a network system that included a file server plus 5 multimedia computers with touch screens. The expert software program was written to guide participants in using the workbook and tail behavioral goals based on their prior computer use and the answers they provided on baseline questionnaires. The three primary paths in the computer addressed nutrition, fitness, and psychobehavioral content. | Behavioural | 2, 3 |
| Staff ConsultationThe staff consultation component included 6 closed-group workshop sessions and up to 18 telephone or face-to-face consultations with a registered dietician and/or a cognitive behavioral therapist. The workshop curriculum focused on specific activities and assignments in the workbook, and it encouraged use of the computer to identify problems and issues. | Behavioural | 3 |
Primary outcome
weight loss
Time frame: 1 year
1 secondary outcome
diabetes and cardiovascular risk
Time frame: 1 year
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 10 Jan 2020.
- Results publication: PubMed 11678486Wylie-Rosett J, Swencionis C, Ginsberg M, Cimino C, Wassertheil-Smoller S, Caban A, Segal-Isaacson CJ, Martin T, Lewis J. Computerized weight loss intervention optimizes staff time: the clinical and cost results of a controlled clinical trial conducted in a managed care setting. J Am Diet Assoc. 2001 Oct;101(10):1155-62; quiz 1163-4. doi: 10.1016/s0002-8223(01)00284-x.
- Derived from this study: PubMed 22888821Swencionis C, Wylie-Rosett J, Lent MR, Ginsberg M, Cimino C, Wassertheil-Smoller S, Caban A, Segal-Isaacson CJ. Weight change, psychological well-being, and vitality in adults participating in a cognitive-behavioral weight loss program. Health Psychol. 2013 Apr;32(4):439-46. doi: 10.1037/a0029186. Epub 2012 Aug 13.
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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.
Judith Wylie-Rosett, EdD principal investigator
Albert Einstein College of Medicine
Charles Swencionis, PhD study chair
Yeshiva University
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Albert Einstein College of Medicine.
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 3 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 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00674180, which also lists 2 linked publications.
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 10 Jan 2020.