ObesityLIFENCT00670462
Maintenance-Tailored Obesity Treatment
A study testing Standard Behavioral Treatment (SBT) and Maintenance-Tailored Treatment (MTT) in people with Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
This study is a randomized clinical trial comparing state-of-the-art, standard behavior therapy for weight loss (SBT) with a maintenance tailored treatment (MTT) with varied behavioral prescriptions, goals, and formats over time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Standard Behavioral Treatment (SBT) and Maintenance-Tailored Treatment (MTT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be 18 years of age or older
- Body mass index between 30.0 and 37.0
Who cannot join
- serious current physical disease (e.g., heart disease, cancer, and diabetes) for which physician supervision of diet and exercise would be needed.
- initial fasting glucose values above 120 mg/dl
- resting blood pressure at or above 90 DBP or 150 SBP will be strongly encouraged to see their primary care physician for further evaluation and will not be accepted into the study unless they do so and have physician consent for participation.
- physical problems that preclude their participation in the diet and exercise components of the program
- currently taking weight-loss medications
- currently participating in another formal weight loss-program
Show all 9Show fewer
- currently pregnant or plan to become pregnant during the next 30 months
- currently receiving treatment for a major psychological disorder or have scores on the Beck Depression Inventory above 27.0, indicative of likely clinical depression.
- only one individual per household accepted into the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, School of Public Health
Minneapolis, Minnesota, 55454
About this study
This study is a randomized clinical trial comparing state-of-the-art, standard behavior therapy for weight loss (SBT) with a maintenance tailored treatment (MTT) with varied behavioral prescriptions, goals, and formats over time. The overall hypothesis in the study is that the two treatment approaches will show different patterns of weight loss over time, and in particular that the MTT approach would be associated with better long-term maintenance of weight loss.
Read the detailed description
Recent dramatic increases in prevalence have made obesity the number one nutritional problem in the US. Of particular concern is the fact that, although available treatments are effective in producing clinically significant weight loss, their ability to sustain weight loss long term is poor. This study is based on a conceptual analysis of this problem that argues for greater attention to two issues related to the temporal dynamics of the challenge of long-term weight control. These are: 1) the environment is continually changing and is not supportive of weight control and 2) the intervention methods that are effective in inducing short-term changes in behaviors and weight often lose their potency over time because of habituation.
This study is a randomized trial in which obese men and women are assigned to one of two study conditions, Standard Behavior Treatment (SBT) or Maintenance-Tailored Treatment (MTT). The MTT has adaptation to change as its central theme. A primary technique that is used to convey this theme that is different than traditional behavior treatment is that participants are asked to deliberately change weight-loss strategies systematically over time rather than to use the same approach consistently across time. Frequent change serves as a platform for teaching a larger variety of weight-control skills and thus strengthening study participants ability to adapt their weight-control strategies to changing circumstances. Changing weight-control strategies regularly also helps to reduce the extent to which habituation to strategies implemented invariantly over time diminish the salience of behavioral cues and the potency of behavioral reinforcers for sustaining weight-control efforts over time. Individuals in both treatment groups receive active intervention for a period of 18 months, followed by 12 months of no-treatment follow-up.
The primary hypothesis tested is that MTT will produce larger mean weight losses at 30-month follow-up than SBT. Moreover, it is predicted that the better long-term success of the MTT group will be due primarily to better weight-loss success beyond 6 months, the point at which most people begin to regain weight with standard therapy.
- Conditions
- Obesity
- Being tested
- Standard Behavioral Treatment (SBT), Maintenance-Tailored Treatment (MTT)
- Keywords
- obesity, weight loss, treatment
- 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.
Standard Behavioral Treatment (SBT)Behavioural
Also called lifestyle intervention
SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training. MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. Between each segment, participants are left on their own for 4 weeks with instructions to continue regular weighing but otherwise to make their own choices about what to do for weight control.
Maintenance-Tailored Treatment (MTT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard Behavioral Treatment (SBT) | Active comparator | Standard Behavioral Treatment (SBT) for weight loss intervention introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). Receives: Behavioral: Standard Behavioral Treatment (SBT) |
| Maintenance-Tailored Treatment (MTT) | Experimental | Maintenance-Tailored Treatment (MTT) for weight loss intervention treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. Receives: Behavioral: Maintenance-Tailored Treatment (MTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Measured: Baseline to18 months
Secondary outcomes (17)
Physical Activity, Energy Expenditure
change from baseline in energy expenditure at 6 months
Measured: Baseline and 6 months
Change From Baseline in Energy Intake at 6 Months
Measured: Baseline and 6 months
Blood Pressure
Measured: baseline, 6, 12, 18, and 30 months
Waist-to-hip Ratio at Baseline
Measured: baseline
Blood Glucose
Measured: baseline, 6, 12, 18, and 30 months
Insulin
Measured: baseline, 6, 12, 18, and 30 months
HDL
Measured: baseline, 6, 12, 18, and 30 months
Triglycerides
Measured: baseline, 6, 12, 18, and 30 months
Mood State
Measured: baseline, 6, 12, 18, and 30 months
Physical Activity, Energy Expenditure
change from baseline in energy expenditure at 12 months
Measured: 12 months
Physical Activity, Energy Expenditure
change from baseline in energy expenditure at 18 months
Measured: 18 months
Change From Baseline in Energy Intake at 12months
Measured: 12 months
Change From Baseline in Energy Intake at 18 Months
Measured: 18 months
Waist-to-hip Ratio at 6 Months
Measured: 6 months
Waist-to-hip Ratio at 12 Months
Measured: 12 months
Waist-to-hip Ratio at 18 Months
Measured: 18 months
Waist-to-hip Ratio at 30 Months
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startOct 2004
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington
- Responsible party
- Sponsor
- Investigators
- Robert W Jeffery, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670462
- Sponsor's protocol ID
- 0402S56276
- Other IDs
- R01DK067362
- Acronym
- LIFE
- Status last verified
- Feb 2017
- First submitted
- 30 Apr 2008
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance-Tailored Obesity Treatment
- ClinicalTrials.gov ID
- NCT00670462
- Acronym / sponsor ID
- LIFE / 0402S56276
- Conditions
- Obesity
- Keywords
- obesity, weight loss, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington
- Study start
- Oct 2004
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 May 2008 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized clinical trial comparing state-of-the-art, standard behavior therapy for weight loss (SBT) with a maintenance tailored treatment (MTT) with varied behavioral prescriptions, goals, and formats over time. The overall hypothesis in the study is that the two treatment approaches will show different patterns of weight loss over time, and in particular that the MTT approach would be associated with better long-term maintenance of weight loss.
Detailed description
Recent dramatic increases in prevalence have made obesity the number one nutritional problem in the US. Of particular concern is the fact that, although available treatments are effective in producing clinically significant weight loss, their ability to sustain weight loss long term is poor. This study is based on a conceptual analysis of this problem that argues for greater attention to two issues related to the temporal dynamics of the challenge of long-term weight control. These are: 1) the environment is continually changing and is not supportive of weight control and 2) the intervention methods that are effective in inducing short-term changes in behaviors and weight often lose their potency over time because of habituation.
This study is a randomized trial in which obese men and women are assigned to one of two study conditions, Standard Behavior Treatment (SBT) or Maintenance-Tailored Treatment (MTT). The MTT has adaptation to change as its central theme. A primary technique that is used to convey this theme that is different than traditional behavior treatment is that participants are asked to deliberately change weight-loss strategies systematically over time rather than to use the same approach consistently across time. Frequent change serves as a platform for teaching a larger variety of weight-control skills and thus strengthening study participants ability to adapt their weight-control strategies to changing circumstances. Changing weight-control strategies regularly also helps to reduce the extent to which habituation to strategies implemented invariantly over time diminish the salience of behavioral cues and the potency of behavioral reinforcers for sustaining weight-control efforts over time. Individuals in both treatment groups receive active intervention for a period of 18 months, followed by 12 months of no-treatment follow-up.
The primary hypothesis tested is that MTT will produce larger mean weight losses at 30-month follow-up than SBT. Moreover, it is predicted that the better long-term success of the MTT group will be due primarily to better weight-loss success beyond 6 months, the point at which most people begin to regain weight with standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Behavioral Treatment (SBT) | Active comparator | Behavioral: Standard Behavioral Treatment (SBT)Standard Behavioral Treatment (SBT) for weight loss intervention introduces a core set of instructions on diet and exercise at the beginning of the intervention and then "embellishes" these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity). |
| Maintenance-Tailored Treatment (MTT) | Experimental | Behavioral: Maintenance-Tailored Treatment (MTT)Maintenance-Tailored Treatment (MTT) for weight loss intervention treats diet and exercise strategy "embellishments" as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must be 18 years of age or older
- Body mass index between 30.0 and 37.0
Key exclusion criteria (9 listed)
- serious current physical disease (e.g., heart disease, cancer, and diabetes) for which physician supervision of diet and exercise would be needed.
- initial fasting glucose values above 120 mg/dl
- resting blood pressure at or above 90 DBP or 150 SBP will be strongly encouraged to see their primary care physician for further evaluation and will not be accepted into the study unless they do so and have physician consent for participation.
- physical problems that preclude their participation in the diet and exercise components of the program
- currently taking weight-loss medications
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 |
|---|---|---|
| Standard Behavioral Treatment (SBT)Also: lifestyle interventionSBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training. MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. Between each segment, participants are left on their own for 4 weeks with instructions to continue regular weighing but otherwise to make their own choices about what to do for weight control. | Behavioural | Standard Behavioral Treatment (SBT) |
| Maintenance-Tailored Treatment (MTT) | Behavioural | Maintenance-Tailored Treatment (MTT) |
Primary outcome
Change in Body Weight
Time frame: Baseline to18 months
17 secondary outcomes
Physical Activity, Energy Expenditure
Time frame: Baseline and 6 months
Change From Baseline in Energy Intake at 6 Months
Time frame: Baseline and 6 months
Blood Pressure
Time frame: baseline, 6, 12, 18, and 30 months
Waist-to-hip Ratio at Baseline
Time frame: baseline
Blood Glucose
Time frame: baseline, 6, 12, 18, and 30 months
Insulin
Time frame: baseline, 6, 12, 18, and 30 months
HDL
Time frame: baseline, 6, 12, 18, and 30 months
Triglycerides
Time frame: baseline, 6, 12, 18, and 30 months
Mood State
Time frame: baseline, 6, 12, 18, and 30 months
Physical Activity, Energy Expenditure
Time frame: 12 months
Physical Activity, Energy Expenditure
Time frame: 18 months
Change From Baseline in Energy Intake at 12months
Time frame: 12 months
Change From Baseline in Energy Intake at 18 Months
Time frame: 18 months
Waist-to-hip Ratio at 6 Months
Time frame: 6 months
Waist-to-hip Ratio at 12 Months
Time frame: 12 months
Waist-to-hip Ratio at 18 Months
Time frame: 18 months
Waist-to-hip Ratio at 30 Months
Time frame: 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Behavioral Treatment (SBT) and Maintenance-Tailored Treatment (MTT) in people with Obesity, 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?
The sponsor lists 2 inclusion and 9 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 22 Mar 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?
Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Baseline to18 months). 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 22 Mar 2017.