ObesityNCT03999892
Adapted ACHIEVE Curriculum for Community Mental Health Settings
A study testing ACHIEVE in people with Obesity and Mental Disorders, Severe, run by Johns Hopkins University at 1 site in United States.
Trial summary
In light of the obesity epidemic in persons with serious mental illness (SMI), there is an urgent need to scale-up behavioral interventions that have demonstrated efficacy in the clinical trial setting such as the intervention in the National Institute of Mental Health (NIMH)-funded Achieving Healthy Lifestyles in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Mental Disorders, Severe
- What is being tested?
- ACHIEVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 30 Sep 2019
- 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
- aged 18 or older
- consumers at Prologue psychiatric rehabilitation program
- expected to be in the rehabilitation program for at least 6 months after enrollment
- able to attend the intervention classes 3 days per week
- able and willing to give informed consent and participate in the intervention
- have a body mass index (BMI) over 25 kg/m2
- be interested in losing weight
Who cannot join
- any underlying medical conditions that could seriously reduce life expectancy, ability to participate in the study, or for which dietary change or physical activity may be contraindicated and/or require medical supervision by a physician (e.g., medication-dependent diabetes mellitus, cancer or malignant tumor, lung disease requiring supplemental oxygen, dementia or cognitive impairment, consumption of more than 14 drinks per week, eating disorders, angina, or diagnosis in the last 12 months of myocardial infarction, congestive heart failure, transient ischemic attack or stroke, liver disease or kidney disease)
- women who are pregnant or breastfeeding
- individuals with an inability to walk to participate in exercise class as demonstrated by walking up and down 2 flights of stairs
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: ACHIEVE-D Pilot Study
In light of the obesity epidemic in persons with serious mental illness (SMI), there is an urgent need to scale-up behavioral interventions that have demonstrated efficacy in the clinical trial setting such as the intervention in the National Institute of Mental Health (NIMH)-funded Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) trial. To increase ease of adoption and sustained implementation of ACHIEVE in community mental health programs, the format needs to be adapted for delivery by community mental health staff. Based on the investigators' experience conducting the ACHIEVE trial, this study team had modified the ACHIEVE intervention into a new ACHIEVE curriculum appropriate for community mental health settings. Therefore, the investigators will pilot test 8 weeks of this curriculum in a community-based psychiatric rehabilitation program (PRP) to determine whether this format is acceptable to participating PRP consumers with SMI as well as PRP staff and peer leaders.
Read the detailed description
Prevalence of obesity is significantly elevated and a leading cause of preventable death in people with serious mental illness (SMI) through its effects on other cardiovascular disease (CVD) risk factors and CVD. Behavioral interventions targeting changes in diet and exercise need to be tailored to the needs of people with SMI, such as memory impairment and limited executive function. The NIMH-funded Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) trial tested a behavioral weight-loss intervention for persons with SMI and demonstrated clinically significant weight loss. In light of the obesity epidemic in persons with SMI, there is an urgent need to scale-up interventions like ACHIEVE. To increase ease of adoption and sustained implementation of ACHIEVE in community mental health programs, the format needs to be adapted for delivery by community mental health staff. Based on the investigators' experience conducting the ACHIEVE trial, this study team had modified the ACHIEVE intervention into a new ACHIEVE curriculum appropriate for community mental health settings. Therefore, the investigators will pilot test 8 weeks of this curriculum in a community-based psychiatric rehabilitation program (PRP) to determine whether this format is acceptable to participating PRP consumers with SMI as well as PRP staff and peer leaders.
- Conditions
- Obesity, Mental Disorders, Severe
- Being tested
- ACHIEVE
- Medical subject headings
- Obesity, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACHIEVEBehavioural
The investigators will test two modules of the adapted video-assisted curriculum format of 45 to 60-minute multipurpose classes, which will include a segment on group weight management (~20-30 minutes) and group exercise (~20-30 minutes). Within each module, the group weight management topic varies by week, and within each week the content of the three weight management groups builds gradually and is purposely repeated. Within each module, the group exercise classes will focus on mild to moderate intensity aerobic exercise using an exercise video. In this pilot study, a trained study interventionist will deliver the ACHIEVE-D curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Pilot weight management module | Experimental | Consumers with serious mental illness who attend a psychiatric rehabilitation program will participate in a pilot of modules of a group-based diet and physical activity program. Staff/ peer leaders a psychiatric rehabilitation program will observe sessions. Receives: Behavioral: ACHIEVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Serious Mental Illness Satisfaction With ACHIEVE Curriculum as Assessed by a Yes Response to Two Questions
Two questions during focus group:
- Would want to continue with the ACHIEVE Program (Yes/No)
- Would recommend the ACHIEVE program to other clients who want to lose weight (Yes/No)
Measured: One week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start24 Jun 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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 (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gail Daumit, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999892
- Sponsor's protocol ID
- IRB00194122
- Other IDs
- P50MH115842
- Status last verified
- Aug 2022
- First submitted
- 25 Jun 2019
- Last updated
- 1 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACHIEVE-D Pilot Study
- ClinicalTrials.gov ID
- NCT03999892
- Acronym / sponsor ID
- IRB00194122
- Conditions
- Obesity, Mental Disorders, Severe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Posted 1 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In light of the obesity epidemic in persons with serious mental illness (SMI), there is an urgent need to scale-up behavioral interventions that have demonstrated efficacy in the clinical trial setting such as the intervention in the National Institute of Mental Health (NIMH)-funded Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) trial. To increase ease of adoption and sustained implementation of ACHIEVE in community mental health programs, the format needs to be adapted for delivery by community mental health staff. Based on the investigators' experience conducting the ACHIEVE trial, this study team had modified the ACHIEVE intervention into a new ACHIEVE curriculum appropriate for community mental health settings. Therefore, the investigators will pilot test 8 weeks of this curriculum in a community-based psychiatric rehabilitation program (PRP) to determine whether this format is acceptable to participating PRP consumers with SMI as well as PRP staff and peer leaders.
Detailed description
Prevalence of obesity is significantly elevated and a leading cause of preventable death in people with serious mental illness (SMI) through its effects on other cardiovascular disease (CVD) risk factors and CVD. Behavioral interventions targeting changes in diet and exercise need to be tailored to the needs of people with SMI, such as memory impairment and limited executive function. The NIMH-funded Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) trial tested a behavioral weight-loss intervention for persons with SMI and demonstrated clinically significant weight loss. In light of the obesity epidemic in persons with SMI, there is an urgent need to scale-up interventions like ACHIEVE. To increase ease of adoption and sustained implementation of ACHIEVE in community mental health programs, the format needs to be adapted for delivery by community mental health staff. Based on the investigators' experience conducting the ACHIEVE trial, this study team had modified the ACHIEVE intervention into a new ACHIEVE curriculum appropriate for community mental health settings. Therefore, the investigators will pilot test 8 weeks of this curriculum in a community-based psychiatric rehabilitation program (PRP) to determine whether this format is acceptable to participating PRP consumers with SMI as well as PRP staff and peer leaders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot weight management module | Experimental | Behavioral: ACHIEVEConsumers with serious mental illness who attend a psychiatric rehabilitation program will participate in a pilot of modules of a group-based diet and physical activity program. Staff/ peer leaders a psychiatric rehabilitation program will observe sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged 18 or older
- consumers at Prologue psychiatric rehabilitation program
- expected to be in the rehabilitation program for at least 6 months after enrollment
- able to attend the intervention classes 3 days per week
- able and willing to give informed consent and participate in the intervention
Key exclusion criteria (3 listed)
- any underlying medical conditions that could seriously reduce life expectancy, ability to participate in the study, or for which dietary change or physical activity may be contraindicated and/or require medical supervision by a physician (e.g., medication-dependent diabetes mellitus, cancer or malignant tumor, lung disease requiring supplemental oxygen, dementia or cognitive impairment, consumption of more than 14 drinks per week, eating disorders, angina, or diagnosis in the last 12 months of myocardial infarction, congestive heart failure, transient ischemic attack or stroke, liver disease or kidney disease)
- women who are pregnant or breastfeeding
- individuals with an inability to walk to participate in exercise class as demonstrated by walking up and down 2 flights of stairs
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 |
|---|---|---|
| ACHIEVEThe investigators will test two modules of the adapted video-assisted curriculum format of 45 to 60-minute multipurpose classes, which will include a segment on group weight management (~20-30 minutes) and group exercise (~20-30 minutes). Within each module, the group weight management topic varies by week, and within each week the content of the three weight management groups builds gradually and is purposely repeated. Within each module, the group exercise classes will focus on mild to moderate intensity aerobic exercise using an exercise video. In this pilot study, a trained study interventionist will deliver the ACHIEVE-D curriculum. | Behavioural | Pilot weight management module |
Primary outcome
Participants With Serious Mental Illness Satisfaction With ACHIEVE Curriculum as Assessed by a Yes Response to Two Questions
Time frame: One week post-intervention
Two questions during focus group: * Would want to continue with the ACHIEVE Program (Yes/No) * Would recommend the ACHIEVE program to other clients who want to lose weight (Yes/No)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Individual participant dataSharing planned: No
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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 Daumit principal investigator
Johns Hopkins University
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 in people with Obesity and Mental Disorders, Severe, 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 7 inclusion and 3 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 1 Sep 2022. 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 1 Sep 2022). 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?
Participants With Serious Mental Illness Satisfaction With ACHIEVE Curriculum as Assessed by a Yes Response to Two Questions (time frame: One week post-intervention). 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 NCT03999892, which also lists 1 linked publication.
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 1 Sep 2022.