Adapted ACHIEVE Curriculum for Community Mental Health Settings

NCT ID: NCT03999892

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2019-09-30

Brief 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 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.

Conditions

Obesity; Mental Disorders, Severe

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pilot weight management module

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.

Group Type: EXPERIMENTAL

ACHIEVE

Intervention Type: BEHAVIORAL

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.

Interventions

ACHIEVE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Daumit

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23517118 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P50MH115842

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00194122

Identifier Type: -

Identifier Source: org_study_id