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Weight Management & Wellness for People With Psychiatric Disabilities

Weight Management & Wellness for People With Psychiatric Disabilities

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05128045
Enrollment
113
Registered
2021-11-19
Start date
2016-10-01
Completion date
2019-03-07
Last updated
2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Illness, Obesity

Keywords

Obesity, Weight Management, Serious Mental Illness

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.

Interventions

BEHAVIORALNEW-R

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

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Perceived Competence Scale from Baseline to 8-monthsStudy entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3Measures 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-monthsStudy entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3Measure 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

MeasureTime frameDescription
Change in Self-Rated Abilities for Health Practices Scale from Baseline to 8-monthsStudy entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3Self 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-monthsStudy entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3Weight in pounds

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026