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

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ClinicalTrials.gov Identifier: NCT03695289
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Obesity Mentally Ill Persons Behavioral: iOTA SMI Behavioral: Health Education Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptation of an Evidence-based Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: iOTA-SMI
Participants randomized to iOTA-SMI arm will participate in a 16 week interactive obesity treatment approach (iOTA) program approach.
Behavioral: iOTA SMI
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.

Active Comparator: Health Education Control
Participants randomized to the Health Education Control arm will receive monthly in-person health coaching visits for 16 weeks.
Behavioral: Health Education Control
Participants randomized to the Health Education Control arm will receive monthly counseling on energy balance, physical activity and nutrition.




Primary Outcome Measures :
  1. Change in Body Mass Index (BMI) [ Time Frame: Baseline and 16 Weeks ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695289


Contacts
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Contact: Amanda Ricchio 314-362-5939 ricchioa@wustl.edu
Contact: Julie Schweiger, CCRC 314-362-3153 schweigj@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Amanda Ricchio    314-362-5939    ricchioa@wustl.edu   
Contact: Julie Schweiger, CCRC    314-362-3153    schweigj@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Ginger E Nicol, MD Washington University School of Medicine

Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03695289     History of Changes
Other Study ID Numbers: 201806118
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Antipsychotics
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms