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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK067362 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Washington | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Behavioral Treatment (SBT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Baseline to18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity, Energy Expenditure | change from baseline in energy expenditure at 6 months | Baseline and 6 months |
| Change From Baseline in Energy Intake at 6 Months | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert W Jeffery, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota, School of Public Health | Minneapolis | Minnesota | 55454 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Behavioral Treatment (SBT) | Standard Behavioral Treatment (SBT) for weight loss 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). weight loss 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. |
| FG001 | Maintenance-Tailored Treatment (MTT) | Maintenance-Tailored Treatment (MTT) for weight loss 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. weight loss intervention: 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. B |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Behavioral Treatment (SBT) | Standard Behavioral Treatment (SBT) for weight loss 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). weight loss 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight | Waist-to-hip Ratio" was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized. | Posted | Mean | Standard Deviation | kg | Baseline to18 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Behavioral Treatment (SBT) | Standard Behavioral Treatment (SBT) for weight loss 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). weight loss 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heart attack death | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac events | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert W. Jeffery PhD | University of Minnesota | 612-626-8580 | jeffe001@umn.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
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| Maintenance-Tailored Treatment (MTT) | Behavioral |
|
| Blood Pressure | baseline, 6, 12, 18, and 30 months |
| Waist-to-hip Ratio at Baseline | baseline |
| Blood Glucose | baseline, 6, 12, 18, and 30 months |
| Insulin | baseline, 6, 12, 18, and 30 months |
| HDL | baseline, 6, 12, 18, and 30 months |
| Triglycerides | baseline, 6, 12, 18, and 30 months |
| Mood State | baseline, 6, 12, 18, and 30 months |
| Physical Activity, Energy Expenditure | change from baseline in energy expenditure at 12 months | 12 months |
| Physical Activity, Energy Expenditure | change from baseline in energy expenditure at 18 months | 18 months |
| Change From Baseline in Energy Intake at 12months | 12 months |
| Change From Baseline in Energy Intake at 18 Months | 18 months |
| Waist-to-hip Ratio at 6 Months | 6 months |
| Waist-to-hip Ratio at 12 Months | 12 months |
| Waist-to-hip Ratio at 18 Months | 18 months |
| Waist-to-hip Ratio at 30 Months | 30 months |
| BG001 | Maintenance-Tailored Treatment (MTT) | Maintenance-Tailored Treatment (MTT) for weight loss 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. weight loss intervention: 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. B |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| energy intake (kcal/day) | Mean | Standard Deviation | kcal/day |
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| energy expenditure (kcal/wk) | Mean | Standard Deviation | kcal/wk |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| OG001 | Maintenance-Tailored Treatment (MTT) | Maintenance-Tailored Treatment (MTT) for weight loss 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. weight loss intervention: 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. B |
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| Secondary | Physical Activity, Energy Expenditure | change from baseline in energy expenditure at 6 months | Waist-to-hip Ratio" was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized. | Posted | Mean | Standard Error | kcal/wk | Baseline and 6 months |
|
|
|
| Secondary | Change From Baseline in Energy Intake at 6 Months | Waist-to-hip Ratio" was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized. | Posted | Mean | Standard Error | kcal/day | Baseline and 6 months |
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| Secondary | Blood Pressure | Not Posted | baseline, 6, 12, 18, and 30 months | Participants |
| Secondary | Waist-to-hip Ratio at Baseline | Posted | Mean | Standard Error | ratio | baseline |
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|
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| Secondary | Blood Glucose | Not Posted | baseline, 6, 12, 18, and 30 months | Participants |
| Secondary | Insulin | Not Posted | baseline, 6, 12, 18, and 30 months | Participants |
| Secondary | HDL | Not Posted | baseline, 6, 12, 18, and 30 months | Participants |
| Secondary | Triglycerides | Not Posted | baseline, 6, 12, 18, and 30 months | Participants |
| Secondary | Mood State | Not Posted | baseline, 6, 12, 18, and 30 months | Participants |
| Secondary | Physical Activity, Energy Expenditure | change from baseline in energy expenditure at 12 months | Posted | Mean | Standard Error | kcal/wk | 12 months |
|
|
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| Secondary | Physical Activity, Energy Expenditure | change from baseline in energy expenditure at 18 months | Posted | Mean | Standard Error | kcal/wk | 18 months |
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| Secondary | Change From Baseline in Energy Intake at 12months | Posted | Mean | Standard Error | kcal/day | 12 months |
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| Secondary | Change From Baseline in Energy Intake at 18 Months | Posted | Mean | Standard Error | kcal/day | 18 months |
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| Secondary | Waist-to-hip Ratio at 6 Months | Posted | Mean | Standard Error | ratio | 6 months |
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|
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| Secondary | Waist-to-hip Ratio at 12 Months | Posted | Mean | Standard Error | ratio | 12 months |
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| Secondary | Waist-to-hip Ratio at 18 Months | Posted | Mean | Standard Error | ratio | 18 months |
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| Secondary | Waist-to-hip Ratio at 30 Months | Posted | Mean | Standard Error | ratio | 30 months |
|
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|
| 0 |
| 106 |
| 29 |
| 106 |
| EG001 | Maintenance-Tailored Treatment (MTT) | Maintenance-Tailored Treatment (MTT) for weight loss 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. weight loss intervention: 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. B | 1 | 107 | 26 | 107 |
| Skin event | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| musculoskeletal events | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| surgical events | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
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| ear event | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| gastrointestinal events | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| endocrine events | Endocrine disorders | MedDRA (10.0) | Non-systematic Assessment |
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| pregnancies | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Non-systematic Assessment |
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| reproductive events | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
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| infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| renal event | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| eye events | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
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| skin event | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |