NCT05128045

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

2.4 years

First QC Date

October 20, 2021

Last Update Submit

November 8, 2021

Conditions

ObesityMental Illness

Keywords

Obesity, Weight Management, Serious Mental Illness

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3

Study Arms (2)

Experimental: NEW-R Intervention

EXPERIMENTAL

NEW-R Intervention plus services as usual

Behavioral: NEW-R

Control

NO INTERVENTION

Services as usual

Interventions

NEW-RBEHAVIORAL

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

Experimental: NEW-R Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36377367DERIVED

MeSH Terms

Conditions

ObesityMental Disorders

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 19, 2021

Study Start

October 1, 2016

Primary Completion

March 7, 2019

Study Completion

March 7, 2019

Last Updated

November 19, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share