Overweight and Obesity
Conditions
Keywords
Serious Mental Illness, Weight Loss
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALACHIEVE Intervention
Group and individual weight loss counseling and group physical activity classes for 18 months
OTHERControl
group health classes quarterly with topics not related to weight
Sponsors
National Institute of Mental Health (NIMH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 18 and older; * Overweight, defined by Body Mass Index at least 25.0 kg/m2; * Able and willing to give informed consent and participate in the intervention; * On the same psychiatric medications within the 30 days before baseline weight (dose changes allowed;) * Able to attend at least 2 intervention sessions per week during initial 6-month phase;
Exclusion criteria
* Contraindication to weight loss * Receiving active cancer treatment (radiation/chemotherapy) * Liver failure * History of anorexia nervosa; * 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; * Twenty pound or greater weight loss in 3 months prior to baseline, as documented by staff measurement; * Inability to walk to participate in exercise class; * Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician; * Alcohol or substance use disorder either: 1) active and determined to be incompatible with participation in the intervention through discussion with program staff; or 2) new abstinence from alcohol or substance use disorder in past 30 days; * Planning to leave rehabilitation center within 6 months or move out of geographic area within 18 months; * Investigator judgment (e.g., for concerns over safety, adherence or follow-up); * Weight greater than 400 pounds.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight Loss in Kilograms (kg) | 6 and 18 months | Change is from baseline to 6 months and baseline to 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference in Centimeters (cm) | Measured at baseline, 6 and 18 months | Change in waist circumference in centimeters (cm) from baseline to 18 months |
| Change in Systolic and Diastolic Blood Pressure (mmHg) | Measured at baseline, 6 and 18 months | Change in systolic and diastolic blood pressure (mmHg) from baseline to 18 months |
| Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | Measured at baseline, 6 and 18 months | Change in Lipids (total cholesterol, LDL, HDL and Triglyceride (mg/dL) from baseline to 18 months |
| Minutes Cycled During Cycle Ergometry Testing | Baseline, 6 and 18 months | Minutes cycled during standardized cycle ergometry testing protocol; higher number of minutes cycled indicates better outcome. |
| Health Status as Measured by the SF-12 | Baseline, 6 and 18 months | 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. |
| Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline, 6 and 18 months | Total score range between 0 and 60, higher scores indicating more depressive symptoms |
| Framingham Cardiovascular Risk Score | Measured at baseline, 6 and 18 months | Higher score indicates greater cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 144 |
| 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 | 147 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Censored per protocol | 3 | 1 |
| Overall Study | Death | 1 | 3 |
| Overall Study | Incarceration | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Pregnancy | 1 | 1 |
Baseline characteristics
| Characteristic | ACHIEVE Intervention | Total | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 9 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 137 Participants | 282 Participants | 145 Participants |
| Age, Continuous | 46.6 years STANDARD_DEVIATION 11.5 | 45.3 years STANDARD_DEVIATION 11.3 | 44.1 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 13 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 139 Participants | 278 Participants | 139 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| primary psychiatric diagnosis bipolar disorder | 28 Participants | 64 Participants | 36 Participants |
| primary psychiatric diagnosis major depressive disorder | 18 Participants | 35 Participants | 17 Participants |
| primary psychiatric diagnosis other | 13 Participants | 23 Participants | 10 Participants |
| primary psychiatric diagnosis schizoaffective disorder | 41 Participants | 84 Participants | 43 Participants |
| primary psychiatric diagnosis schizophrenia | 44 Participants | 85 Participants | 41 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants | 111 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 82 Participants | 163 Participants | 81 Participants |
| Region of Enrollment United States | 144 Participants | 291 Participants | 147 Participants |
| Sex: Female, Male Female | 74 Participants | 146 Participants | 72 Participants |
| Sex: Female, Male Male | 70 Participants | 145 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 144 | 3 / 147 |
| other Total, other adverse events | 0 / 144 | 0 / 147 |
| serious Total, serious adverse events | 42 / 144 | 47 / 147 |
Outcome results
Primary
Change in Weight Loss in Kilograms (kg)
Change is from baseline to 6 months and baseline to 18 months
Time frame: 6 and 18 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ACHIEVE Intervention | Change in Weight Loss in Kilograms (kg) | baseline to 6 month change | -1.8 kg |
| ACHIEVE Intervention | Change in Weight Loss in Kilograms (kg) | baseline to 18 month change | -3.4 kg |
| Control | Change in Weight Loss in Kilograms (kg) | baseline to 6 month change | -0.3 kg |
| Control | Change in Weight Loss in Kilograms (kg) | baseline to 18 month change | -0.2 kg |
Comparison: 6 month intervention versus control95% CI: [-2.6, -0.4]
Comparison: 18 month intervention versus control95% CI: [-5.1, -1.2]
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
Time frame: Measured at baseline, 6 and 18 months
Population: Reported for those who completed this measure at these follow-up data points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ACHIEVE Intervention | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 6 month total chol change | -4.8 mg/dl |
| ACHIEVE Intervention | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 18 month total chol change | -5.6 mg/dl |
| ACHIEVE Intervention | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 6 month LDL chol change | -3.8 mg/dl |
| ACHIEVE Intervention | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 18 month LDL chol change | -5.5 mg/dl |
| ACHIEVE Intervention | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 6 month HDL chol change | 0.2 mg/dl |
| ACHIEVE Intervention | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 18 month HDL chol change | 0.6 mg/dl |
| ACHIEVE Intervention | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 6 month TRIG change | -6.3 mg/dl |
| ACHIEVE Intervention | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 18 month TRIG change | 3.5 mg/dl |
| Control | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 18 month TRIG change | 5.0 mg/dl |
| Control | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 6 month total chol change | -1.9 mg/dl |
| Control | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 6 month HDL chol change | 0.8 mg/dl |
| Control | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 18 month total chol change | -0.3 mg/dl |
| Control | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 6 month TRIG change | -0.8 mg/dl |
| Control | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 6 month LDL chol change | -2.5 mg/dl |
| Control | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 18 month HDL chol change | -0.1 mg/dl |
| Control | Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) | baseline to 18 month LDL chol change | -0.9 mg/dl |
Comparison: 6 month total chol intervention versus control95% CI: [-9.9, 4.1]
Comparison: 18 month total chol intervention versus control95% CI: [-14.9, 4.4]
Comparison: 6 month LDL chol intervention versus control95% CI: [-7.5, 5.1]
Comparison: 18 month LDL chol intervention versus control95% CI: [-13.1, 3.9]
Comparison: 6 month HDL chol intervention versus control95% CI: [-2.9, 1.7]
Comparison: 18 month HDL intervention versus control95% CI: [-1.8, 3.1]
Comparison: 6 month TRIG intervention versus control95% CI: [-23.5, 12.4]
Comparison: 18 month TRIG intervention versus control95% CI: [-27, 23.9]
Secondary
Change in Systolic and Diastolic Blood Pressure (mmHg)
Change in systolic and diastolic blood pressure (mmHg) from baseline to 18 months
Time frame: Measured at baseline, 6 and 18 months
Population: Reported for those who completed this measure at these follow-up data points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ACHIEVE Intervention | Change in Systolic and Diastolic Blood Pressure (mmHg) | baseline to 6 month systolic change | -2.5 mmhg |
| ACHIEVE Intervention | Change in Systolic and Diastolic Blood Pressure (mmHg) | baseline to 6 month diastolic change | -0.7 mmhg |
| ACHIEVE Intervention | Change in Systolic and Diastolic Blood Pressure (mmHg) | baseline to 18 month systolic change | -1.1 mmhg |
| ACHIEVE Intervention | Change in Systolic and Diastolic Blood Pressure (mmHg) | baseline to 18 month diastolic change | -0.6 mmhg |
| Control | Change in Systolic and Diastolic Blood Pressure (mmHg) | baseline to 18 month diastolic change | -1.9 mmhg |
| Control | Change in Systolic and Diastolic Blood Pressure (mmHg) | baseline to 6 month systolic change | -2.1 mmhg |
| Control | Change in Systolic and Diastolic Blood Pressure (mmHg) | baseline to 18 month systolic change | -2.7 mmhg |
| Control | Change in Systolic and Diastolic Blood Pressure (mmHg) | baseline to 6 month diastolic change | -0.9 mmhg |
Comparison: 6 month systolic intervention versus control95% CI: [-3.2, 2.4]
Comparison: 6 month diastolic intervention versus control95% CI: [-1.6, 2.1]
Comparison: 18 month systolic intervention versus control95% CI: [-1.6, 4.8]
Comparison: 18 month diastolic intervention versus control95% CI: [-0.9, 3.4]
Secondary
Change in Waist Circumference in Centimeters (cm)
Change in waist circumference in centimeters (cm) from baseline to 18 months
Time frame: Measured at baseline, 6 and 18 months
Population: Reported for those who completed this measure at these follow-up data points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ACHIEVE Intervention | Change in Waist Circumference in Centimeters (cm) | baseline to 6 month change | -1.5 cm |
| ACHIEVE Intervention | Change in Waist Circumference in Centimeters (cm) | baseline to 18 month change | -2.2 cm |
| Control | Change in Waist Circumference in Centimeters (cm) | baseline to 6 month change | 0.5 cm |
| Control | Change in Waist Circumference in Centimeters (cm) | baseline to 18 month change | -1.9 cm |
Comparison: 6 month intervention versus control95% CI: [-3.6, -0.4]
Comparison: 18 month intervention versus control95% CI: [-4.1, 0.3]
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
Time frame: Baseline, 6 and 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACHIEVE Intervention | Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline | 19.7 score on a scale | Standard Deviation 11.3 |
| ACHIEVE Intervention | Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D) | 6 months | 18.7 score on a scale | Standard Deviation 11.6 |
| ACHIEVE Intervention | Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D) | 18 months | 18.7 score on a scale | Standard Deviation 11 |
| Control | Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline | 20.1 score on a scale | Standard Deviation 11.2 |
| Control | Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D) | 6 months | 20.9 score on a scale | Standard Deviation 11.5 |
| Control | Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D) | 18 months | 19.5 score on a scale | Standard Deviation 11.2 |
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
Time frame: Measured at baseline, 6 and 18 months
Population: Only included data for those participants who had all variables in calculation equation. Not modeled
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACHIEVE Intervention | Framingham Cardiovascular Risk Score | Baseline | 0.0999 score on a scale | Standard Deviation 0.1027 |
| ACHIEVE Intervention | Framingham Cardiovascular Risk Score | 6 month | 0.1029 score on a scale | Standard Deviation 0.1093 |
| ACHIEVE Intervention | Framingham Cardiovascular Risk Score | 18 month | 0.1035 score on a scale | Standard Deviation 0.0972 |
| Control | Framingham Cardiovascular Risk Score | Baseline | 0.0989 score on a scale | Standard Deviation 0.0924 |
| Control | Framingham Cardiovascular Risk Score | 6 month | 0.0991 score on a scale | Standard Deviation 0.0953 |
| Control | Framingham Cardiovascular Risk Score | 18 month | 0.0978 score on a scale | Standard Deviation 0.0925 |
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.
Time frame: Baseline, 6 and 18 months
Population: Reported for those who completed this measure at these follow-up data points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACHIEVE Intervention | Health Status as Measured by the SF-12 | 18 months PCS score | 46.2 score on a scale | Standard Deviation 11.6 |
| ACHIEVE Intervention | Health Status as Measured by the SF-12 | Baseline MCS score | 45.0 score on a scale | Standard Deviation 11.4 |
| ACHIEVE Intervention | Health Status as Measured by the SF-12 | 6 months MCS score | 46.2 score on a scale | Standard Deviation 10.8 |
| ACHIEVE Intervention | Health Status as Measured by the SF-12 | 18 months MCS score | 45.1 score on a scale | Standard Deviation 11.5 |
| ACHIEVE Intervention | Health Status as Measured by the SF-12 | Baseline PCS score | 45.1 score on a scale | Standard Deviation 10.6 |
| ACHIEVE Intervention | Health Status as Measured by the SF-12 | 6 months PCS Score | 45.5 score on a scale | Standard Deviation 10.4 |
| Control | Health Status as Measured by the SF-12 | Baseline PCS score | 43.4 score on a scale | Standard Deviation 9.7 |
| Control | Health Status as Measured by the SF-12 | 18 months PCS score | 44.4 score on a scale | Standard Deviation 10.1 |
| Control | Health Status as Measured by the SF-12 | 18 months MCS score | 45.5 score on a scale | Standard Deviation 11.2 |
| Control | Health Status as Measured by the SF-12 | Baseline MCS score | 45.8 score on a scale | Standard Deviation 10.2 |
| Control | Health Status as Measured by the SF-12 | 6 months PCS Score | 43.8 score on a scale | Standard Deviation 10.8 |
| Control | Health Status as Measured by the SF-12 | 6 months MCS score | 44.4 score on a scale | Standard Deviation 10.9 |
Secondary
Minutes Cycled During Cycle Ergometry Testing
Minutes cycled during standardized cycle ergometry testing protocol; higher number of minutes cycled indicates better outcome.
Time frame: Baseline, 6 and 18 months
Population: Cycle ergometry test was not completed for those who completed data collection off-site where no bicycle ergometer was available. Results are not modeled.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACHIEVE Intervention | Minutes Cycled During Cycle Ergometry Testing | baseline | 6.95 minutes | Standard Deviation 2.64 |
| ACHIEVE Intervention | Minutes Cycled During Cycle Ergometry Testing | 6 month | 7.12 minutes | Standard Deviation 2.86 |
| ACHIEVE Intervention | Minutes Cycled During Cycle Ergometry Testing | 18 month | 7.19 minutes | Standard Deviation 3.03 |
| Control | Minutes Cycled During Cycle Ergometry Testing | baseline | 6.86 minutes | Standard Deviation 2.86 |
| Control | Minutes Cycled During Cycle Ergometry Testing | 6 month | 6.91 minutes | Standard Deviation 2.82 |
| Control | Minutes Cycled During Cycle Ergometry Testing | 18 month | 6.79 minutes | Standard Deviation 2.6 |