ObesityNCT05128045
Weight Management & Wellness for People With Psychiatric Disabilities
A study testing NEW-R in people with Obesity and Mental Illness, run by University of Illinois Chicago.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Mental Illness
- What is being tested?
- NEW-R
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 7 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Obesity, Mental Illness
- Being tested
- NEW-R
- Keywords
- Obesity, Weight Management, Serious Mental Illness
- Medical subject headings
- Obesity, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEW-RBehavioural
Eight session class on nutrition, physical activity, diet, and weight management
| Study group | Role | What they receive |
|---|---|---|
| Experimental: NEW-R Intervention | Experimental | NEW-R Intervention plus services as usual Receives: Behavioral: NEW-R |
| Control | No intervention | Services as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
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.
Measured: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Secondary outcomes (2)
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.
Measured: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Change in Weight from Baseline to 8-months
Weight in pounds
Measured: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Oct 2016
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith A. Cook, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128045
- Sponsor's protocol ID
- 2016-0118
- Status last verified
- Nov 2021
- First submitted
- 20 Oct 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36377367
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Management & Wellness for People With Psychiatric Disabilities
- ClinicalTrials.gov ID
- NCT05128045
- Acronym / sponsor ID
- 2016-0118
- Conditions
- Obesity, Mental Illness
- Keywords
- Obesity, Weight Management, Serious Mental Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: NEW-R Intervention | Experimental | Behavioral: NEW-RNEW-R Intervention plus services as usual |
| Control | No intervention | –Services as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEW-REight session class on nutrition, physical activity, diet, and weight management | Behavioural | Experimental: NEW-R Intervention |
Primary outcome
Change in Perceived Competence Scale from Baseline to 8-months
Time frame: 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
Time frame: 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.
2 secondary outcomes
Change in Self-Rated Abilities for Health Practices Scale from Baseline to 8-months
Time frame: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Change in Weight from Baseline to 8-months
Time frame: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Derived from this study: PubMed 36377367Brown 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NEW-R in people with Obesity and Mental Illness, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Competence Scale from Baseline to 8-months (time frame: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05128045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.