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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
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Management, Serious Mental Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 20, 2021
    Last Updated
    November 8, 2021
    Sponsor
    University of Illinois at Chicago
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    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

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