Weight Management & Wellness for People With Psychiatric Disabilities

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT05128045

Collaborator

(none)

113

Enrollment

Arms

29.1

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Mental Illness	Behavioral: NEW-R	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

113 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Weight Management & Wellness for People With Psychiatric Disabilities

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Mar 7, 2019

Actual Study Completion Date :

Mar 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: NEW-R Intervention NEW-R Intervention plus services as usual	Behavioral: NEW-R Eight session class on nutrition, physical activity, diet, and weight management
No Intervention: Control Services as usual

Arm

Intervention/Treatment

Experimental: Experimental: NEW-R Intervention

NEW-R Intervention plus services as usual

Behavioral: NEW-R

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

No Intervention: Control

Services as usual

Outcome Measures

Primary Outcome Measures

Change in Perceived Competence Scale from Baseline to 8-months [Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3]
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 [Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3]
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 [Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3]
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 [Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3]
Weight in pounds

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Illinois at Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Judith A. Cook, Professor, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT05128045

Other Study ID Numbers:

2016-0118

First Posted:

Nov 19, 2021

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Judith A. Cook, Professor, University of Illinois at Chicago

Obesity, Weight Management, Serious Mental Illness

Additional relevant MeSH terms:

Mental Disorders

Study Results

No Results Posted as of Nov 19, 2021