Trial Outcomes & Findings for Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation (NCT NCT00902694)
NCT ID: NCT00902694
Last Updated: 2025-07-30
Results Overview
Change is from baseline to 6 months and baseline to 18 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
291 participants
Primary outcome timeframe
6 and 18 months
Results posted on
2025-07-30
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
147
|
|
Overall Study
COMPLETED
|
137
|
142
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Censored per protocol
|
3
|
1
|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
Incarceration
|
1
|
0
|
Baseline Characteristics
Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation
Baseline characteristics by cohort
| Measure |
ACHIEVE Intervention
n=144 Participants
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
|
Control
n=147 Participants
Control arm receives group health classes quarterly with topics not related to weight
Control: group health classes quarterly with topics not related to weight
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
137 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
144 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
primary psychiatric diagnosis
schizophrenia
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
primary psychiatric diagnosis
schizoaffective disorder
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
primary psychiatric diagnosis
bipolar disorder
|
28 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
primary psychiatric diagnosis
major depressive disorder
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
primary psychiatric diagnosis
other
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 and 18 monthsChange is from baseline to 6 months and baseline to 18 months
Outcome measures
| Measure |
ACHIEVE Intervention
n=144 Participants
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
|
Control
n=147 Participants
Control arm receives group health classes quarterly with topics not related to weight
Control: group health classes quarterly with topics not related to weight
|
|---|---|---|
|
Change in Weight Loss in Kilograms (kg)
baseline to 18 month change
|
-3.4 kg
Interval -4.7 to -2.1
|
-0.2 kg
Interval -1.7 to 1.3
|
|
Change in Weight Loss in Kilograms (kg)
baseline to 6 month change
|
-1.8 kg
Interval -2.5 to -1.0
|
-0.3 kg
Interval -1.0 to 0.5
|
SECONDARY outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: Cycle ergometry test was not completed for those who completed data collection off-site where no bicycle ergometer was available. Results are not modeled.
Minutes cycled during standardized cycle ergometry testing protocol; higher number of minutes cycled indicates better outcome.
Outcome measures
| Measure |
ACHIEVE Intervention
n=136 Participants
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
|
Control
n=142 Participants
Control arm receives group health classes quarterly with topics not related to weight
Control: group health classes quarterly with topics not related to weight
|
|---|---|---|
|
Minutes Cycled During Cycle Ergometry Testing
baseline
|
6.95 minutes
Standard Deviation 2.64
|
6.86 minutes
Standard Deviation 2.86
|
|
Minutes Cycled During Cycle Ergometry Testing
6 month
|
7.12 minutes
Standard Deviation 2.86
|
6.91 minutes
Standard Deviation 2.82
|
|
Minutes Cycled During Cycle Ergometry Testing
18 month
|
7.19 minutes
Standard Deviation 3.03
|
6.79 minutes
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: Measured at baseline, 6 and 18 monthsPopulation: Reported for those who completed this measure at these follow-up data points.
Change in waist circumference in centimeters (cm) from baseline to 18 months
Outcome measures
| Measure |
ACHIEVE Intervention
n=113 Participants
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
|
Control
n=124 Participants
Control arm receives group health classes quarterly with topics not related to weight
Control: group health classes quarterly with topics not related to weight
|
|---|---|---|
|
Change in Waist Circumference in Centimeters (cm)
baseline to 6 month change
|
-1.5 cm
Interval -2.6 to -0.4
|
0.5 cm
Interval -0.7 to 1.7
|
|
Change in Waist Circumference in Centimeters (cm)
baseline to 18 month change
|
-2.2 cm
Interval -3.8 to -0.7
|
-1.9 cm
Interval -4.1 to 0.3
|
SECONDARY outcome
Timeframe: Measured at baseline, 6 and 18 monthsPopulation: Reported for those who completed this measure at these follow-up data points.
Change in systolic and diastolic blood pressure (mmHg) from baseline to 18 months
Outcome measures
| Measure |
ACHIEVE Intervention
n=134 Participants
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
|
Control
n=140 Participants
Control arm receives group health classes quarterly with topics not related to weight
Control: group health classes quarterly with topics not related to weight
|
|---|---|---|
|
Change in Systolic and Diastolic Blood Pressure (mmHg)
baseline to 6 month systolic change
|
-2.5 mmhg
Interval -4.7 to -0.2
|
-2.1 mmhg
Interval -3.8 to -0.4
|
|
Change in Systolic and Diastolic Blood Pressure (mmHg)
baseline to 6 month diastolic change
|
-0.7 mmhg
Interval -2.0 to 0.7
|
-0.9 mmhg
Interval -2.2 to 0.3
|
|
Change in Systolic and Diastolic Blood Pressure (mmHg)
baseline to 18 month systolic change
|
-1.1 mmhg
Interval -3.5 to 1.3
|
-2.7 mmhg
Interval -4.8 to -0.7
|
|
Change in Systolic and Diastolic Blood Pressure (mmHg)
baseline to 18 month diastolic change
|
-0.6 mmhg
Interval -2.2 to 0.9
|
-1.9 mmhg
Interval -3.3 to -0.4
|
SECONDARY outcome
Timeframe: Measured at baseline, 6 and 18 monthsPopulation: Reported for those who completed this measure at these follow-up data points.
Change in Lipids (total cholesterol, LDL, HDL and Triglyceride (mg/dL) from baseline to 18 months
Outcome measures
| Measure |
ACHIEVE Intervention
n=124 Participants
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
|
Control
n=125 Participants
Control arm receives group health classes quarterly with topics not related to weight
Control: group health classes quarterly with topics not related to weight
|
|---|---|---|
|
Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)
baseline to 6 month total chol change
|
-4.8 mg/dl
Interval -9.8 to 0.2
|
-1.9 mg/dl
Interval -6.8 to 3.0
|
|
Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)
baseline to 18 month total chol change
|
-5.6 mg/dl
Interval -11.8 to 0.6
|
-0.3 mg/dl
Interval -7.8 to 7.1
|
|
Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)
baseline to 6 month LDL chol change
|
-3.8 mg/dl
Interval -8.0 to 0.5
|
-2.5 mg/dl
Interval -7.2 to 2.1
|
|
Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)
baseline to 18 month LDL chol change
|
-5.5 mg/dl
Interval -10.7 to -0.2
|
-0.9 mg/dl
Interval -7.6 to 5.8
|
|
Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)
baseline to 6 month HDL chol change
|
0.2 mg/dl
Interval -1.0 to 1.4
|
0.8 mg/dl
Interval -1.2 to 2.8
|
|
Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)
baseline to 18 month HDL chol change
|
0.6 mg/dl
Interval -1.2 to 2.3
|
-0.1 mg/dl
Interval -1.8 to 1.7
|
|
Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)
baseline to 6 month TRIG change
|
-6.3 mg/dl
Interval -16.6 to 3.9
|
-0.8 mg/dl
Interval -15.6 to 14.0
|
|
Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)
baseline to 18 month TRIG change
|
3.5 mg/dl
Interval -15.1 to 22.1
|
5.0 mg/dl
Interval -12.4 to 22.4
|
SECONDARY outcome
Timeframe: Measured at baseline, 6 and 18 monthsPopulation: Only included data for those participants who had all variables in calculation equation. Not modeled
Higher score indicates greater cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke
Outcome measures
| Measure |
ACHIEVE Intervention
n=143 Participants
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
|
Control
n=146 Participants
Control arm receives group health classes quarterly with topics not related to weight
Control: group health classes quarterly with topics not related to weight
|
|---|---|---|
|
Framingham Cardiovascular Risk Score
Baseline
|
0.0999 score on a scale
Standard Deviation 0.1027
|
0.0989 score on a scale
Standard Deviation 0.0924
|
|
Framingham Cardiovascular Risk Score
6 month
|
0.1029 score on a scale
Standard Deviation 0.1093
|
0.0991 score on a scale
Standard Deviation 0.0953
|
|
Framingham Cardiovascular Risk Score
18 month
|
0.1035 score on a scale
Standard Deviation 0.0972
|
0.0978 score on a scale
Standard Deviation 0.0925
|
SECONDARY outcome
Timeframe: Baseline, 6 and 18 monthsPopulation: Reported for those who completed this measure at these follow-up data points.
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.
Outcome measures
| Measure |
ACHIEVE Intervention
n=144 Participants
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
|
Control
n=147 Participants
Control arm receives group health classes quarterly with topics not related to weight
Control: group health classes quarterly with topics not related to weight
|
|---|---|---|
|
Health Status as Measured by the SF-12
Baseline PCS score
|
45.1 score on a scale
Standard Deviation 10.6
|
43.4 score on a scale
Standard Deviation 9.7
|
|
Health Status as Measured by the SF-12
6 months PCS Score
|
45.5 score on a scale
Standard Deviation 10.4
|
43.8 score on a scale
Standard Deviation 10.8
|
|
Health Status as Measured by the SF-12
18 months PCS score
|
46.2 score on a scale
Standard Deviation 11.6
|
44.4 score on a scale
Standard Deviation 10.1
|
|
Health Status as Measured by the SF-12
Baseline MCS score
|
45.0 score on a scale
Standard Deviation 11.4
|
45.8 score on a scale
Standard Deviation 10.2
|
|
Health Status as Measured by the SF-12
6 months MCS score
|
46.2 score on a scale
Standard Deviation 10.8
|
44.4 score on a scale
Standard Deviation 10.9
|
|
Health Status as Measured by the SF-12
18 months MCS score
|
45.1 score on a scale
Standard Deviation 11.5
|
45.5 score on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Baseline, 6 and 18 monthsTotal score range between 0 and 60, higher scores indicating more depressive symptoms
Outcome measures
| Measure |
ACHIEVE Intervention
n=144 Participants
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
|
Control
n=147 Participants
Control arm receives group health classes quarterly with topics not related to weight
Control: group health classes quarterly with topics not related to weight
|
|---|---|---|
|
Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D)
18 months
|
18.7 score on a scale
Standard Deviation 11.0
|
19.5 score on a scale
Standard Deviation 11.2
|
|
Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D)
Baseline
|
19.7 score on a scale
Standard Deviation 11.3
|
20.1 score on a scale
Standard Deviation 11.2
|
|
Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D)
6 months
|
18.7 score on a scale
Standard Deviation 11.6
|
20.9 score on a scale
Standard Deviation 11.5
|
Adverse Events
ACHIEVE Intervention
Serious events: 42 serious events
Other events: 0 other events
Deaths: 2 deaths
Control
Serious events: 47 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
ACHIEVE Intervention
n=144 participants at risk
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
|
Control
n=147 participants at risk
Control arm receives group health classes quarterly with topics not related to weight
Control: group health classes quarterly with topics not related to weight
|
|---|---|---|
|
Psychiatric disorders
psychiatric hospitalization
|
14.6%
21/144 • Number of events 31 • baseline through 18 months
|
20.4%
30/147 • Number of events 51 • baseline through 18 months
|
|
General disorders
medical hospitalizations
|
18.1%
26/144 • Number of events 33 • baseline through 18 months
|
12.9%
19/147 • Number of events 24 • baseline through 18 months
|
Other adverse events
Adverse event data not reported
Additional Information
Gail Daumit, MD, MHS
Johns Hopkins University School of Medicine
Phone: 410-614-6460
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place