Adapted ACHIEVE Curriculum for Community Mental Health Settings

NCT03999892 | Completed Results

• 2 other identifiers: IRB00194122P50MH115842
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Mental Disorders, Severe

Outcome Measures

Primary Outcomes (1)

• 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)

  One week post-intervention

Study Arms (1)

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.

Behavioral: ACHIEVE

Interventions

ACHIEVE 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.

Pilot weight management module

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 23517118 BACKGROUND

MeSH Terms

Conditions

Obesity; Mental Disorders

Interventions

Achieve no-mix

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gail Daumit
• Organization: Johns Hopkins

gduamit@jhmi.edu

410 614 6460

Study Officials

• Gail Daumit

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: June 24, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: September 1, 2022
• Results First Posted: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)