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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH080964 | U.S. NIH Grant/Contract | View source | |
| DAHBR 96-BHB | |||
| NIMH R01MH080964 |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine whether a behavioral weight loss intervention including dietary counseling and exercise is effective in helping people with serious mental illnesses lose weight.
The objective of this study is to perform a randomized clinical trial (ACHIEVE) to definitively test the efficacy of an innovative, practical intervention to accomplish weight loss in overweight and obese persons with SMI. This multi-site trial will enroll consumers with SMI who attend ten psychiatric rehabilitation centers in Maryland and randomize participants to the ACHIEVE intervention or control. Intervention participants will receive group and individual weight loss counseling sessions and group physical activity classes. Co-primary outcomes will be change in weight from baseline to 6 and 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACHIEVE Intervention | Experimental | Group and individual weight counseling and group physical activity classes for 18 months. |
|
| Control | Other | Control arm receives group health classes quarterly with topics not related to weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACHIEVE Intervention | Behavioral | Group and individual weight loss counseling and group physical activity classes for 18 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight Loss in Kilograms (kg) | Change is from baseline to 6 months and baseline to 18 months | 6 and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Minutes Cycled During Cycle Ergometry Testing | Minutes cycled during standardized cycle ergometry testing protocol; higher number of minutes cycled indicates better outcome. | Baseline, 6 and 18 months |
| Change in Waist Circumference in Centimeters (cm) |
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Age 18 and older;
Exclusion criteria
Contraindication to weight loss
Cardiovascular event (unstable angina, myocardial infarction) within previous 6 months;
Prior or planned bariatric surgery;
Use of prescription weight loss medication or over-the-counter orlistat within 3 months
if participant does not agree to stop taking it;
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| Name | Affiliation | Role |
|---|---|---|
| Gail L. Daumit, MD, MHS | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prohealth | Baltimore | Maryland | 21207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21144025 | Background | Casagrande SS, Jerome GJ, Dalcin AT, Dickerson FB, Anderson CA, Appel LJ, Charleston J, Crum RM, Young DR, Guallar E, Frick KD, Goldberg RW, Oefinger M, Finkelstein J, Gennusa JV 3rd, Fred-Omojole O, Campbell LM, Wang NY, Daumit GL. Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial. BMC Psychiatry. 2010 Dec 13;10:108. doi: 10.1186/1471-244X-10-108. | |
| 28398006 | Derived | Janssen EM, Jerome GJ, Dalcin AT, Gennusa JV 3rd, Goldsholl S, Frick KD, Wang NY, Appel LJ, Daumit GL. A cost analysis of implementing a behavioral weight loss intervention in community mental health settings: Results from the ACHIEVE trial. Obesity (Silver Spring). 2017 Jun;25(6):1006-1013. doi: 10.1002/oby.21836. Epub 2017 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ACHIEVE Intervention | Group and individual weight counseling and group physical activity classes for 18 months. ACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months |
| FG001 | Control | Control arm receives group health classes quarterly with topics not related to weight Control: group health classes quarterly with topics not related to weight |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACHIEVE Intervention | Group and individual weight counseling and group physical activity classes for 18 months. ACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Weight Loss in Kilograms (kg) | Change is from baseline to 6 months and baseline to 18 months | Posted | Mean | 95% Confidence Interval | kg | 6 and 18 months |
|
baseline through 18 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 | ACHIEVE Intervention | Group and individual weight counseling and group physical activity classes for 18 months. ACHIEVE Intervention: Group and individual weight loss counseling and group physical activity classes for 18 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychiatric hospitalization | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gail Daumit, MD, MHS | Johns Hopkins University School of Medicine | 410-614-6460 | gdaumit@jhmi.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Control | Other | group health classes quarterly with topics not related to weight |
|
Change in waist circumference in centimeters (cm) from baseline to 18 months |
| Measured at baseline, 6 and 18 months |
| Change in Systolic and Diastolic Blood Pressure (mmHg) | Change in systolic and diastolic blood pressure (mmHg) from baseline to 18 months | Measured at baseline, 6 and 18 months |
| Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | Change in Lipids (total cholesterol, LDL, HDL and Triglyceride (mg/dL) from baseline to 18 months | Measured at baseline, 6 and 18 months |
| Framingham Cardiovascular Risk Score | Higher score indicates greater cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke | Measured at baseline, 6 and 18 months |
| Health Status as Measured by the SF-12 | Health status reported for the SF-12 in two subscales-physical component summary (PCS) and the mental component summary (MCS). Subscale score ranges from 0-100 with higher scores indicating better physical or mental health. | Baseline, 6 and 18 months |
| Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D) | Total score range between 0 and 60, higher scores indicating more depressive symptoms | Baseline, 6 and 18 months |
| 23517118 | Derived | Daumit GL, Dickerson FB, Wang NY, Dalcin A, Jerome GJ, Anderson CA, Young DR, Frick KD, Yu A, Gennusa JV 3rd, Oefinger M, Crum RM, Charleston J, Casagrande SS, Guallar E, Goldberg RW, Campbell LM, Appel LJ. A behavioral weight-loss intervention in persons with serious mental illness. N Engl J Med. 2013 Apr 25;368(17):1594-602. doi: 10.1056/NEJMoa1214530. Epub 2013 Mar 21. |
| Censored per protocol |
|
| Pregnancy |
|
| Incarceration |
|
Control arm receives group health classes quarterly with topics not related to weight Control: group health classes quarterly with topics not related to weight |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| primary psychiatric diagnosis | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Minutes Cycled During Cycle Ergometry Testing | Minutes cycled during standardized cycle ergometry testing protocol; higher number of minutes cycled indicates better outcome. | Cycle ergometry test was not completed for those who completed data collection off-site where no bicycle ergometer was available. Results are not modeled. | Posted | Mean | Standard Deviation | minutes | Baseline, 6 and 18 months |
|
|
|
| Secondary | Change in Waist Circumference in Centimeters (cm) | Change in waist circumference in centimeters (cm) from baseline to 18 months | Reported for those who completed this measure at these follow-up data points. | Posted | Mean | 95% Confidence Interval | cm | Measured at baseline, 6 and 18 months |
|
|
|
|
| Secondary | Change in Systolic and Diastolic Blood Pressure (mmHg) | Change in systolic and diastolic blood pressure (mmHg) from baseline to 18 months | Reported for those who completed this measure at these follow-up data points. | Posted | Mean | 95% Confidence Interval | mmhg | Measured at baseline, 6 and 18 months |
|
|
|
|
| Secondary | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | Change in Lipids (total cholesterol, LDL, HDL and Triglyceride (mg/dL) from baseline to 18 months | Reported for those who completed this measure at these follow-up data points. | Posted | Mean | 95% Confidence Interval | mg/dl | Measured at baseline, 6 and 18 months |
|
|
|
|
| Secondary | Framingham Cardiovascular Risk Score | Higher score indicates greater cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke | Only included data for those participants who had all variables in calculation equation. Not modeled | Posted | Mean | Standard Deviation | score on a scale | Measured at baseline, 6 and 18 months |
|
|
|
| Secondary | Health Status as Measured by the SF-12 | Health status reported for the SF-12 in two subscales-physical component summary (PCS) and the mental component summary (MCS). Subscale score ranges from 0-100 with higher scores indicating better physical or mental health. | Reported for those who completed this measure at these follow-up data points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 and 18 months |
|
|
|
| Secondary | Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D) | Total score range between 0 and 60, higher scores indicating more depressive symptoms | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 and 18 months |
|
|
|
| 2 |
| 144 |
| 42 |
| 144 |
| 0 |
| 144 |
| EG001 | Control | Control arm receives group health classes quarterly with topics not related to weight Control: group health classes quarterly with topics not related to weight | 3 | 147 | 47 | 147 | 0 | 147 |
| medical hospitalizations | General disorders | Systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| 18 month |
|
| Mean Difference (Net) |
| -1.9 |
| 2-Sided |
| 95 |
| -4.1 |
| 0.3 |
| Superiority |
| baseline to 18 month systolic change |
|
| baseline to 18 month diastolic change |
|
| Mean Difference (Net) |
| 0.2 |
| 2-Sided |
| 95 |
| -1.6 |
| 2.1 |
| Superiority |
| 18 month systolic intervention versus control | Mean Difference (Net) | 1.6 | 2-Sided | 95 | -1.6 | 4.8 | Superiority |
| 18 month diastolic intervention versus control | Mean Difference (Net) | 1.2 | 2-Sided | 95 | -0.9 | 3.4 | Superiority |
| baseline to 6 month LDL chol change |
|
| baseline to 18 month LDL chol change |
|
| baseline to 6 month HDL chol change |
|
| baseline to 18 month HDL chol change |
|
| baseline to 6 month TRIG change |
|
| baseline to 18 month TRIG change |
|
| Mean Difference (Net) |
| -5.2 |
| 2-Sided |
| 95 |
| -14.9 |
| 4.4 |
| Superiority |
| 6 month LDL chol intervention versus control | Mean Difference (Net) | -1.2 | 2-Sided | 95 | -7.5 | 5.1 | Superiority |
| 18 month LDL chol intervention versus control | Mean Difference (Net) | -4.6 | 2-Sided | 95 | -13.1 | 3.9 | Superiority |
| 6 month HDL chol intervention versus control | Mean Difference (Net) | -0.6 | 2-Sided | 95 | -2.9 | 1.7 | Superiority |
| 18 month HDL intervention versus control | Mean Difference (Net) | 0.6 | 2-Sided | 95 | -1.8 | 3.1 | Superiority |
| 6 month TRIG intervention versus control | Mean Difference (Net) | -5.5 | 2-Sided | 95 | -23.5 | 12.4 | Superiority |
| 18 month TRIG intervention versus control | Mean Difference (Net) | -1.5 | 2-Sided | 95 | -27.0 | 23.9 | Superiority |
| 18 month |
|
| 18 months PCS score |
|
| Baseline MCS score |
|
| 6 months MCS score |
|
| 18 months MCS score |
|
| 18 months |
|