ObesityNCT00062985
Obesity Treatment in a Managed Care Setting
A study testing Mail-based weight loss intervention and Phone-based weight loss intervention in people with Obesity and Weight Loss, run by University of Minnesota at 1 site in United States.
Trial summary
The aim of the present study is to evaluate the effectiveness of two different delivery formats for weight management in a managed care setting. Mail-based weight counseling and phone-based weight counseling will be compared to each other and a control condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Mail-based weight loss intervention and Phone-based weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,801 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Feb 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- at least 18 years of age
- BMI ≥ 27.8 kg/m2 for men
- BMI ≥ 27.3 kg/m2 for non-pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Division of Epidemiology
Minneapolis, Minnesota, 55415
About this study
The aim of the present study is to evaluate the effectiveness of two different delivery formats for weight management in a managed care setting. Mail-based weight counseling and phone-based weight counseling will be compared to each other and a control condition. Primary outcomes are participation rates in programs, weight change, and cost.
- Conditions
- Obesity, Weight Loss
- Being tested
- Mail-based weight loss intervention, Phone-based weight loss intervention
- Keywords
- obesity treatment, weight management, managed care
- 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.
Mail-based weight loss interventionBehavioural
Phone-based weight loss interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Mail-based weight loss intervention | Experimental | Not described Receives: Behavioral: Mail-based weight loss intervention |
| Telephone-based weight loss intervention | Experimental | Not described Receives: Behavioral: Phone-based weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2003 (estimated)
- Study startMar 1999
- Primary completionOct 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- 1,801 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert W. Jeffery, PhD, Principal investigator, University of Minnesota, Division of Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062985
- Sponsor's protocol ID
- OBMANC (completed)
- Other IDs
- R01DK053826
- Status last verified
- Oct 2017
- First submitted
- 18 Jun 2003
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeffery RW, Sherwood NE, Brelje K, Pronk NP, Boyle R, Boucher JL, Hase K. Mail and phone interventions for weight loss in a managed-care setting: Weigh-To-Be one-year outcomes. Int J Obes Relat Metab Disord. 2003 Dec;27(12):1584-92. doi: 10.1038/sj.ijo.0802473.
PubMed 14517547
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Treatment in a Managed Care Setting
- ClinicalTrials.gov ID
- NCT00062985
- Acronym / sponsor ID
- OBMANC (completed)
- Conditions
- Obesity, Weight Loss
- Keywords
- obesity treatment, weight management, managed care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,801 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 1999 (actual)
- Primary completion
- Oct 2003 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 19 Jun 2003 (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 aim of the present study is to evaluate the effectiveness of two different delivery formats for weight management in a managed care setting. Mail-based weight counseling and phone-based weight counseling will be compared to each other and a control condition. Primary outcomes are participation rates in programs, weight change, and cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Mail-based weight loss intervention | Experimental | Behavioral: Mail-based weight loss intervention |
| Telephone-based weight loss intervention | Experimental | Behavioral: Phone-based weight loss intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Mail-based weight loss intervention | Behavioural | Mail-based weight loss intervention |
| Phone-based weight loss intervention | Behavioural | Telephone-based weight loss intervention |
Primary outcome
Change in body weight
Time frame: 6 and 12 months
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 24 Oct 2017.
- Results publication: PubMed 14517547Jeffery RW, Sherwood NE, Brelje K, Pronk NP, Boyle R, Boucher JL, Hase K. Mail and phone interventions for weight loss in a managed-care setting: Weigh-To-Be one-year outcomes. Int J Obes Relat Metab Disord. 2003 Dec;27(12):1584-92. doi: 10.1038/sj.ijo.0802473.
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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.
Robert W. Jeffery, PhD principal investigator
University of Minnesota, Division of Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mail-based weight loss intervention and Phone-based weight loss intervention in people with Obesity and Weight Loss, run by University of Minnesota 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?
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 24 Oct 2017. 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?
Change in body weight (time frame: 6 and 12 months). 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 NCT00062985, which also lists 1 linked publication.
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 24 Oct 2017.