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Weight Management & Wellness for People With Psychiatric Disabilities

NCT ID: NCT05128045

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2019-03-07

Brief Summary

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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

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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.

Conditions

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Obesity Mental Illness

Keywords

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Obesity, Weight Management, Serious Mental Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental: NEW-R Intervention

NEW-R Intervention plus services as usual

Group Type EXPERIMENTAL

NEW-R

Intervention Type BEHAVIORAL

Eight session class on nutrition, physical activity, diet, and weight management

Control

Services as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NEW-R

Eight session class on nutrition, physical activity, diet, and weight management

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Judith A. Cook

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Brown C, Cook JA, Jonikas JA, Steigman PJ, Burke-Miller J, Hamilton MM, Rosen C, Tessman DC, Santos A. Nutrition and Exercise for Wellness and Recovery: A Randomized Controlled Trial of a Community-Based Health Intervention. Psychiatr Serv. 2023 May 1;74(5):463-471. doi: 10.1176/appi.ps.202200038. Epub 2022 Nov 15.

Reference Type DERIVED
PMID: 36377367 (View on PubMed)

Other Identifiers

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2016-0118

Identifier Type: -

Identifier Source: org_study_id