NCT05041634

Brief Summary

Our aims are to 1) test that our intervention that can be measured with high fidelity. 2) determine the feasibility of the intervention including recruitment, procedures, measures, intervention acceptability and resources . 3)We will also test the outcomes of this 14-week fitness and wellness program based at a YMCA Healthy Living Center to gauge the effects of exercise and activity on patients with behavioral diagnoses including bipolar disorder, schizoaffective disorder, and schizophrenia. We also want to explore the influence of participating in such a program on the perceptions of mental illness among rehabilitation sciences students.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

September 3, 2021

Last Update Submit

September 3, 2021

Conditions

Severe Mental Illness

Keywords

exercise, healthy habits, self-management

Outcome Measures

Primary Outcomes (4)

  • Canadian Occupational Performance Measure

    self-rating goal tool

    pre and post 14 week intervention

  • Coach Fidelity Log Sheet

    Coaches collected data for consistency of intervention

    first 8 weeks

  • PHQ-9

    self-rating depression screener

    week1 and week 14

  • GAD

    Self-rated anxiety scale

    week1 and week 14

Other Outcomes (1)

  • Blood Lipids

    week1 and week 14

Study Arms (1)

Single Group Pilot study pre/post

EXPERIMENTAL

One group of 8 participants receiving 14 week intervention

Behavioral: IHOPE

Interventions

IHOPEBEHAVIORAL

Integrating Healthy Habits Optimized by Community Participation and Engagled Learning

Single Group Pilot study pre/post

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All study participants will be over the age of 21 and will include women and likely some individuals who report minority status with a mental health diagnosis

You may not qualify if:

  • Under the age of 21 or who are not psychologically stable in the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Tulsa, Oklahoma, 74135, United States

Location

MeSH Terms

Conditions

Mental DisordersMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: pilot study of single group pre/post design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2021

First Posted

September 13, 2021

Study Start

July 1, 2019

Primary Completion

August 15, 2019

Study Completion

December 16, 2019

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)