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Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Adults With Early Serious Mental Illness: iOTA-SMI (iOTA-eSMI)

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ClinicalTrials.gov Identifier: NCT03980743
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Using a design-for-dissemination approach, this application proposes to use combined methods to adapt and pilot test an interactive obesity treatment approach (iOTA) for obesity prevention in early serious mental illness (eSMI) that uses text messaging to provide between-visit support. Derived from the lifestyle intervention used in the Diabetes Prevention Program, the parent iOTA targets diet, activity and adherence using web-based and health coach support.

Condition or disease Intervention/treatment Phase
Obesity Overweight Severe Mental Disorder Behavioral: iOTA text messaging intervention Behavioral: Health Education text messaging intervention Not Applicable

Detailed Description:

Most obesity and related complications in serious mental illness (SMI) occur in the context of chronic psychiatric illness, but there are few treatments that work. Behavioral interventions face challenges with long-term effectiveness, implementation and sustainability. Medications have modest effectiveness at best, and/or pose serious side effect risks. This study focuses on prevention of chronic obesity by adapting and pilot testing a prevention-focused, interactive obesity treatment approach (iOTA) for use in persons with early-phase SMI (eSMI) experiencing initial weight gain, overweight or early-stage obesity. The intervention will be adapted from the most studied, effective iOTA, derived from the Diabetes Prevention Program. The parent iOTA uses health coaches who extend their sustainable reach with scalable, inexpensive, semi-automated text messaging. Using a formal evaluation process and a specific implementation science framework, planned adaptations for this application will address mechanisms to improve health-related awareness, insight and self-efficacy skills.

Aim 1: Evaluate barriers and facilitators for intervention engagement, effectiveness and implementation, and identify needed adaptations of the prior iOTA for use in obesity attenuation in eSMI.

Aim 2: Adapt the prior iOTA for use in obesity attenuation in eSMI, aiming to maximize acceptability, engagement, sustainable reach and target engagement for eSMI.

Aim 3: Conduct a randomized pilot and feasibility study of iOTA-eSMI in a diverse sample of adults aged 18-45 with eSMI and initial weight gain, overweight or early class I obesity, comparing iOTA-eSMI to a health education condition.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 Adults With Early Serious Mental Illness: iOTA-SMI
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Active Comparator: iOTA text messaging intervention
There will be a 6 month "active" treatment phase consisting of monthly meetings with a study health coach to develop reasonable health goals and interactive text messaging to provide daily support and self-monitoring of behavior change goals between in-person visits. Participants may receive phone calls between visits from their health coach for additional support if needed. Following the active treatment phase, participants will receive daily health-related text messages for another 3 months.
Behavioral: iOTA text messaging intervention
Over 6 months, participants in the iOTA arm will have monthly in-person visits with a health coach who will work with the participant to set goals for the upcoming month related to healthy eating and activity. The participant will receive daily text message health tips related to their goals, and will be prompted once a week to respond with a text indicating their weight and how they are doing with their goals. Following the 6-month active treatment phase, participants will receive text messages only for another 3 months.
Other Name: iOTA

Placebo Comparator: Health Education text messaging intervention
There will be a 6 month "active" treatment phase consisting of monthly in-person visits with a health coach to learn about healthy eating and activity behaviors, including developing readiness for health behavior change. Participants will not set specific health goals, but will receive weekly text messages about general health tips related to their in-person visits. Following the active treatment phase, participants will receive daily health-related text messages for another 3 months.
Behavioral: Health Education text messaging intervention
Over 6 months, participants in the Health Ed arm will also have monthly in-person visits with a health coach who will provide education on energy balance and problem-solving. Specific goals will not be set, but the health coach will assist participants in problem-solving any challenges. Participants will receive a weekly automated motivational text message health tip from the study related to what they learned in their health coaching sessions. Following the 6-month active treatment phase, participants will receive text messages only for another 3 months.
Other Name: Health Ed




Primary Outcome Measures :
  1. Change in Body Mass Index [ Time Frame: Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks ]
    weight in kilograms/height in meters squared


Secondary Outcome Measures :
  1. Change in Self Efficacy for Healthy Eating and Exercise [ Time Frame: Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks ]
    This questionnaire includes 32 questions in two domains of self efficacy: 1) healthy eating and 2) exercise. Respondents are asked to recall how confident they have felt in doing positive health behaviors since the last study visit. Responses are on a likert scale of 1 - 5 (1 - 2 = I know I cannot do; 3 - 4 = Maybe I can; 5 = I know I can).

  2. Change in Psychophysical Skills & Insight [ Time Frame: Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks ]
    This questionnaire includes 10 questions, with three separate subscales (Self-determination, Cognitive control and Interoceptive Awareness). Respondents are asked to rate their own skills since the last study visit. Responses are on a likert scale of 1-5 (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). Scores are generated for each subscale, as well as a total score. Higher scores indicate greater degree of psychophysical awareness & skills.


Other Outcome Measures:
  1. Percentage response rate to text prompts [ Time Frame: Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks ]
    Treatment engagement

  2. Intervention feasibility, usability and acceptability as measured by the Contextual Technology Adaptation Questionnaire [ Time Frame: Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks ]
    This questionnaire includes 35 questions, with five separate subscales (feedback on: the overall iOTA program, automatic text messages, personalized text messages, in-person visits and between-session phone check-ins). Respondents are asked to rate feasibility, acceptability and usability of the text messaging portion of the intervention since the last study visit. Responses are on a likert scale of 1-3 (1 = not at all/negative; 2 = moderate/neutral; 3 = always/positive). Scores are generated for each subscale, as well as a total score. Higher scores indicate more positive experiences.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-45 years
  • "At-risk" weight defined as greater than 7% weight gain from baseline body weight in the prior 2 years, overweight (BMI 25-29.9) or class I obesity (BMI 30-32.49)
  • Psychiatric disorder with less than 5 years of treatment
  • Receiving case management services in one of the two CMHC study sites
  • Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM SF) score greater than 4
  • University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) score greater than 14
  • Not taking weight loss medications or participating in another behavioral weight loss intervention
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Taking weight loss medications or participating in another behavioral weight loss intervention
  • Documented diagnosis of diabetes and/or treatment with an antidiabetes agent (diagnoses of hypertension and hyperlipidemia acceptable)
  • REALM SF61 score < 4
  • UBACC score < 14
  • Acute suicidality at time of screening
  • Unwilling or unable 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): NCT03980743


Contacts
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Contact: Steve Portnoy, MS (314) 362-5939 steveportnoy@wustl.edu
Contact: Julie Schweiger, CCRC (314) 362-3153 schweigj@wustl.edu

Locations
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United States, Florida
South Florida Behavioral Health Network Not yet recruiting
Miami, Florida, United States, 33126
Contact: Judy Hickson    786-235-7147    jhickson@sfbhn.org   
Principal Investigator: John W Newcomer, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Ginger Nicol, MD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03980743     History of Changes
Other Study ID Numbers: 3622461
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Obesity
Overweight
Severe Mental illness

Additional relevant MeSH terms:
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Obesity
Overweight
Mental Disorders
Psychotic Disorders
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders