Clinical trial NCT05128045: Weight Management & Wellness for People With Psychiatric Disabilities
Official title: Weight Management & Wellness for People With Psychiatric Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Mental Illness
Keywords: Obesity, Weight Management, Serious Mental Illness
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Perceived Competence Scale from Baseline to 8-months
timeFrame: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
measure: Change in Health Promoting Lifestyle Profile from Baseline to 8-months
timeFrame: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Secondary outcomes:
measure: Change in Self-Rated Abilities for Health Practices Scale from Baseline to 8-months
timeFrame: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
measure: Change in Weight from Baseline to 8-months
timeFrame: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Other outcomes:
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