Overweight and ObesityACHIEVENCT00902694

Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

A study testing ACHIEVE Intervention in people with Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overweight and Obesity
What is being tested?: ACHIEVE Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 291 participants
Where: 1 siteUnited States
Study dates: Apr 2008to Sep 2012
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
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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;

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Prohealth
Baltimore, Maryland, 21207

Other trials in United States

About this study

Official title: Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation

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.

Read the 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.

Conditions: Overweight and Obesity
Being tested: ACHIEVE Intervention, Control
Keywords: Serious Mental Illness, Weight Loss
Medical subject headings: Overweight, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACHIEVE InterventionBehavioural
Group and individual weight loss counseling and group physical activity classes for 18 months
ControlOther
group health classes quarterly with topics not related to weight

Study groups in NCT00902694
Study group	Role	What they receive
ACHIEVE Intervention	Experimental	Group and individual weight counseling and group physical activity classes for 18 months. Receives: Behavioral: ACHIEVE Intervention
Control	Other	Control arm receives group health classes quarterly with topics not related to weight Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Weight Loss in Kilograms (kg)
Change is from baseline to 6 months and baseline to 18 months
Measured: 6 and 18 months

Secondary outcomes (7)

Minutes Cycled During Cycle Ergometry Testing
Minutes cycled during standardized cycle ergometry testing protocol; higher number of minutes cycled indicates better outcome.
Measured: Baseline, 6 and 18 months
Change in Waist Circumference in Centimeters (cm)
Change in waist circumference in centimeters (cm) from baseline to 18 months
Measured: 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: 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: 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: 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.
Measured: 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
Measured: Baseline, 6 and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Sep 2012

First posted15 May 2009 (estimated)
Study startApr 2008
Primary completionSep 2012
Study completionSep 2012

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Overweight and ObesityStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 291 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00902694
Sponsor's protocol ID: R01MH080964
Other IDs: R01MH080964, DAHBR 96-BHB, NIMH R01MH080964
Acronym: ACHIEVE
Status last verified: Jul 2025
First submitted: 13 May 2009
Last updated: 30 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 21144025
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.
PubMed 28398006
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.
PubMed 23517118

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation
ClinicalTrials.gov ID: NCT00902694
Acronym / sponsor ID: ACHIEVE / R01MH080964
Conditions: Overweight and Obesity
Keywords: Serious Mental Illness, Weight Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 291 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Apr 2008
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 15 May 2009 (estimated)
Results: Posted 30 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ACHIEVE Intervention	Experimental	Behavioral: ACHIEVE InterventionGroup and individual weight counseling and group physical activity classes for 18 months.
Control	Other	Other: ControlControl arm receives group health classes quarterly with topics not related to weight

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (15 listed)

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;

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
ACHIEVE InterventionGroup and individual weight loss counseling and group physical activity classes for 18 months	Behavioural	ACHIEVE Intervention
Controlgroup health classes quarterly with topics not related to weight	Other	Control

Primary outcome

Change in Weight Loss in Kilograms (kg)
Time frame: 6 and 18 months
Change is from baseline to 6 months and baseline to 18 months

7 secondary outcomes

Minutes Cycled During Cycle Ergometry Testing
Time frame: Baseline, 6 and 18 months
Change in Waist Circumference in Centimeters (cm)
Time frame: Measured at baseline, 6 and 18 months
Change in Systolic and Diastolic Blood Pressure (mmHg)
Time frame: Measured at baseline, 6 and 18 months
Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)
Time frame: Measured at baseline, 6 and 18 months
Framingham Cardiovascular Risk Score
Time frame: Measured at baseline, 6 and 18 months
Health Status as Measured by the SF-12
Time frame: Baseline, 6 and 18 months
Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline, 6 and 18 months

Results and safety

Results posted to the registry on 30 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACHIEVE Intervention	144	137
Control	147	142

Primary outcome: Change in Weight Loss in Kilograms (kg)

Time frame: 6 and 18 months. Mean (95% Confidence Interval). Unit: kg

Measure	ACHIEVE Intervention n = 144	Control n = 147
baseline to 6 month change	-1.8 (-2.5 to -1.0)	-0.3 (-1.0 to 0.5)
baseline to 18 month change	-3.4 (-4.7 to -2.1)	-0.2 (-1.7 to 1.3)

ACHIEVE Intervention vs Control: Mean Difference (Net): -1.5 (95% CI -2.6 to -0.4)
ACHIEVE Intervention vs Control: Mean Difference (Net): -3.2 (95% CI -5.1 to -1.2)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: baseline through 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACHIEVE Intervention	42 of 144 (29.2%)	0 of 144 (0%)	2 of 144
Control	47 of 147 (32%)	0 of 147 (0%)	3 of 147

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21144025Casagrande 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.
Derived from this study: PubMed 28398006Janssen 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.
Derived from this study: PubMed 23517118Daumit 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.

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RecruitingObservational study
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Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
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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.

Gail L. Daumit, MD, MHS principal investigator

Johns Hopkins School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ACHIEVE Intervention in people with Overweight and Obesity, run by Johns Hopkins University 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 0 inclusion and 15 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 30 Jul 2025. 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 30 Jul 2025). 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 Weight Loss in Kilograms (kg) (time frame: 6 and 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00902694, which also lists 3 linked publications.

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 30 Jul 2025.