Weight Management & Wellness for People With Psychiatric Disabilities
Primary Purpose
Obesity, Mental Illness
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NEW-R
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Management, Serious Mental Illness
Eligibility Criteria
Inclusion Criteria:
- Diagnosis with a mental health disorder
- Patient of outpatient program
- Age 18 or older
- Being overweight or obese defined as BMI>=25
- Ability to understand spoken English
Exclusion Criteria:
- Residing in a nursing home
- Cardiac event in past 6 months
- Past episode of anorexia or bulimia
- Pregnancy
- Diagnosis with a terminal illness expected to result in death within 1 year
- Active alcohol or substance abuse or dependence
- Inability to provide informed consent due to diagnosis of dementia or cognitive impairment
- Inability to understand spoken English
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: NEW-R Intervention
Control
Arm Description
NEW-R Intervention plus services as usual
Services as usual
Outcomes
Primary Outcome Measures
Change in Perceived Competence Scale from Baseline to 8-months
Measures ability to stick with a weight management regimen and master new knowledge about diet and exercise. This 4-item scale using a 7-point Likert response format ranging from "not at all true" to "very true". The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome.
Change in Health Promoting Lifestyle Profile from Baseline to 8-months
Measure of health promoting behavior. This is a 26-item scale with a 4-point Likert response format ranging from "never" to "routinely". Minimum value for this scale is 26 and the maximum is 104, with higher scores indicating a better outcome. The dimensions include nutrition, spirituality, and physical activity.
Secondary Outcome Measures
Change in Self-Rated Abilities for Health Practices Scale from Baseline to 8-months
Self perceived health management ability. This 7-item scale uses a 5-point Likert response format ranging from "not at all" to "completely". The minimum value is 7 and the maximum is 35, with higher scores indicating a better outcome.
Change in Weight from Baseline to 8-months
Weight in pounds
Full Information
NCT ID
NCT05128045
First Posted
October 20, 2021
Last Updated
November 8, 2021
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT05128045
Brief Title
Weight Management & Wellness for People With Psychiatric Disabilities
Official Title
Weight Management & Wellness for People With Psychiatric Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
March 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to conduct a randomized controlled trial to test the effectiveness of an intervention called Nutrition and Exercise for Wellness and Recovery (NEW-R) in promoting healthy eating and increased physical activity for better weight management among psychiatric outpatients.
Detailed Description
Weight management is a serious issue for individuals with mental health conditions, especially those who are taking psychiatric medications. The latest estimates are that over half of individuals receiving community mental health services are overweight or obese. This project's objective is to conduct a randomized controlled trial to test the effectiveness of an intervention called Nutrition and Exercise for Wellness and Recovery (NEW-R) in promoting healthy eating and increased physical activity for better weight management among psychiatric outpatients living and working in the community. It is an 8-week, recovery-oriented intervention that is co-led by a trained health educator and a certified mental health peer specialist. The study will take place at the UIC Department of Psychiatry in Chicago. Research participants will be recruited from the Department's outpatient clinics and other community programs, and randomly assigned to receive NEW-R along with services as usual or services as usual alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Mental Illness
Keywords
Obesity, Weight Management, Serious Mental Illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: NEW-R Intervention
Arm Type
Experimental
Arm Description
NEW-R Intervention plus services as usual
Arm Title
Control
Arm Type
No Intervention
Arm Description
Services as usual
Intervention Type
Behavioral
Intervention Name(s)
NEW-R
Intervention Description
Eight session class on nutrition, physical activity, diet, and weight management
Primary Outcome Measure Information:
Title
Change in Perceived Competence Scale from Baseline to 8-months
Description
Measures ability to stick with a weight management regimen and master new knowledge about diet and exercise. This 4-item scale using a 7-point Likert response format ranging from "not at all true" to "very true". The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome.
Time Frame
Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Title
Change in Health Promoting Lifestyle Profile from Baseline to 8-months
Description
Measure of health promoting behavior. This is a 26-item scale with a 4-point Likert response format ranging from "never" to "routinely". Minimum value for this scale is 26 and the maximum is 104, with higher scores indicating a better outcome. The dimensions include nutrition, spirituality, and physical activity.
Time Frame
Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Secondary Outcome Measure Information:
Title
Change in Self-Rated Abilities for Health Practices Scale from Baseline to 8-months
Description
Self perceived health management ability. This 7-item scale uses a 5-point Likert response format ranging from "not at all" to "completely". The minimum value is 7 and the maximum is 35, with higher scores indicating a better outcome.
Time Frame
Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Title
Change in Weight from Baseline to 8-months
Description
Weight in pounds
Time Frame
Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis with a mental health disorder
Patient of outpatient program
Age 18 or older
Being overweight or obese defined as BMI>=25
Ability to understand spoken English
Exclusion Criteria:
Residing in a nursing home
Cardiac event in past 6 months
Past episode of anorexia or bulimia
Pregnancy
Diagnosis with a terminal illness expected to result in death within 1 year
Active alcohol or substance abuse or dependence
Inability to provide informed consent due to diagnosis of dementia or cognitive impairment
Inability to understand spoken English
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Weight Management & Wellness for People With Psychiatric Disabilities
We'll reach out to this number within 24 hrs