Trial Outcomes & Findings for Adapted ACHIEVE Curriculum for Community Mental Health Settings (NCT NCT03999892)

NCT ID: NCT03999892

Last Updated: 2022-09-01

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: One week post-intervention
• Results posted on: 2022-09-01

Participant Flow

Participant milestones

Measure	Consumers With SMI Consumers with serious mental illness who attend a psychiatric rehabilitation program (PRP) will participate in a group-based diet and physical activity program. 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.
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Consumers With SMI Consumers with serious mental illness who attend a psychiatric rehabilitation program (PRP) will participate in a group-based diet and physical activity program. 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.

Overall Study Lost to Follow-up

1

Baseline Characteristics

Adapted ACHIEVE Curriculum for Community Mental Health Settings

Baseline characteristics by cohort

Measure	Participants With Serious Mental Illness n=17 Participants Consumers with serious mental illness who attend a psychiatric rehabilitation program
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.5 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants
Body Mass Index	37.9 Kg/m^2 STANDARD_DEVIATION 9.8 • n=5 Participants

PRIMARY outcome

Timeframe: One week post-intervention

Population: 3 participants did not respond

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)

Outcome measures

Measure	Participants With Serious Mental Illness n=14 Participants Consumers with serious mental illness who attend a psychiatric rehabilitation program will participate in a pilot test of group-based weight management program modules.
Participants With Serious Mental Illness Satisfaction With ACHIEVE Curriculum as Assessed by a Yes Response to Two Questions Would want to continue with the ACHIEVE Program	12 Participants
Participants With Serious Mental Illness Satisfaction With ACHIEVE Curriculum as Assessed by a Yes Response to Two Questions Would recommend the ACHIEVE program to other clients who want to lose weight	13 Participants

Adverse Events

Participants With Serious Mental Illness

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gail Daumit

Johns Hopkins

Phone: 410 614 6460

Email: gduamit@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place