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Completed

NCT Number: NCT05128045

Weight Management & Wellness for People With Psychiatric Disabilities

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.

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Key information

Conditions

Obesity Body Weight Mental Disorders Mental Illness Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NEW-R

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    Weight in pounds

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 19, 2021
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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