Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness

NCT03695289 | Completed

• 1 other identifier: 201806118
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed project aims to pilot and adapt a scalable and sustainable interactive obesity treatment approach (iOTA) program for adults with serious mental illness (SMI). The project consists of 2 arms: the iOTA SMI arm and the Health Education Control Group arm. The investigators hypothesize that participants in the iOTA intervention group will show favorable change in BMI compared to participants in the Health Education Control group, and participants in the iOTA intervention group will show favorable change in self efficacy with respect to healthy eating and activity compared to those in the Health Education Control group.

Conditions

Obesity; Mentally Ill Persons

Keywords

Antipsychotics

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index (BMI)

  Weight in kilograms and height in meters will be measured and combined to calculate BMI in kg/mˆ2 at baseline and following 16 weeks of participation in either an Interactive Obesity Treatment Approach (iOTA) program or a Health Education Program.

  Baseline and 16 Weeks

Study Arms (2)

iOTA-SMI

EXPERIMENTAL

Participants randomized to iOTA-SMI arm will participate in a 16 week interactive obesity treatment approach (iOTA) program approach.

Behavioral: iOTA SMI

Health Education Control

ACTIVE COMPARATOR

Participants randomized to the Health Education Control arm will receive monthly in-person health coaching visits for 16 weeks.

Behavioral: Health Education Control

Interventions

iOTA SMI BEHAVIORAL

Participants randomized to the iOTA SMI arm will undergo an assessment of individual behavior risks, will participate in collaborative goal-setting with a health coach, and will use an interactive text system that will provide ongoing support and self-monitoring of behavior change goals.

iOTA-SMI

Health Education Control BEHAVIORAL

Participants randomized to the Health Education Control arm will receive monthly counseling on energy balance, physical activity and nutrition.

Health Education Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-60 years
• BMI ≥ 28
• have a diagnosis of a severe and persistent mental illness
• psychiatric symptoms present for at least 6 months prior to screening
• at least 6 months of lifetime antipsychotic exposure prior to screening
• not taking weight loss medications or participating in another behavioral weight loss intervention
• enrolled in case management services
• able to provide written informed consent

You may not qualify if:

• acute suicidality at time of screening
• active substance use disorder diagnosis
• unable or unwilling to provide written informed consent

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

• Correll CU, Druss BG, Lombardo I, O'Gorman C, Harnett JP, Sanders KN, Alvir JM, Cuffel BJ. Findings of a U.S. national cardiometabolic screening program among 10,084 psychiatric outpatients. Psychiatr Serv. 2010 Sep;61(9):892-8. doi: 10.1176/ps.2010.61.9.892.

  PMID: 20810587 BACKGROUND

• Colton CW, Manderscheid RW. Congruencies in increased mortality rates, years of potential life lost, and causes of death among public mental health clients in eight states. Prev Chronic Dis. 2006 Apr;3(2):A42. Epub 2006 Mar 15.

  PMID: 16539783 BACKGROUND

• Mitchell AJ, Vancampfort D, Sweers K, van Winkel R, Yu W, De Hert M. Prevalence of metabolic syndrome and metabolic abnormalities in schizophrenia and related disorders--a systematic review and meta-analysis. Schizophr Bull. 2013 Mar;39(2):306-18. doi: 10.1093/schbul/sbr148. Epub 2011 Dec 29.

  PMID: 22207632 BACKGROUND

• Newcomer JW, Hennekens CH. Severe mental illness and risk of cardiovascular disease. JAMA. 2007 Oct 17;298(15):1794-6. doi: 10.1001/jama.298.15.1794. No abstract available.

  PMID: 17940236 BACKGROUND

• Daumit GL, Dickerson FB, Wang NY, Dalcin A, Jerome GJ, Anderson CA, Young DR, Frick KD, Yu A, Gennusa JV 3rd, Oefinger M, Crum RM, Charleston J, Casagrande SS, Guallar E, Goldberg RW, Campbell LM, Appel LJ. A behavioral weight-loss intervention in persons with serious mental illness. N Engl J Med. 2013 Apr 25;368(17):1594-602. doi: 10.1056/NEJMoa1214530. Epub 2013 Mar 21.

  PMID: 23517118 BACKGROUND

• Robinson DG, Schooler NR, Correll CU, John M, Kurian BT, Marcy P, Miller AL, Pipes R, Trivedi MH, Kane JM. Psychopharmacological Treatment in the RAISE-ETP Study: Outcomes of a Manual and Computer Decision Support System Based Intervention. Am J Psychiatry. 2018 Feb 1;175(2):169-179. doi: 10.1176/appi.ajp.2017.16080919. Epub 2017 Sep 15.

  PMID: 28945118 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ginger E Nicol, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: July 5, 2018
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

US (1)