Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness (iOTA-SMI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03695289|
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Mentally Ill Persons||Behavioral: iOTA SMI Behavioral: Health Education Control||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Contact: Amanda Ricchiofirstname.lastname@example.org|
|Contact: Julie Schweiger, CCRCemail@example.com|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Amanda Ricchio 314-362-5939 firstname.lastname@example.org|
|Contact: Julie Schweiger, CCRC 314-362-3153 email@example.com|
|Principal Investigator:||Ginger E Nicol, MD||Washington University School of Medicine|