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

Primary Purpose

Obesity, Overweight, Severe Mental Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iOTA text messaging intervention
Health Education text messaging intervention
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Severe Mental illness

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-60 years
  • At-risk weight defined as greater than 7 percent weight gain in the prior 2 years, overweight as evidenced by BMI 25-29.9, OR class I obesity as evidenced by BMI 30-32.49
  • Serious Mental Illness diagnosis
  • Receiving case management services
  • University of California, San Diego Brief Assessment of Capacity to Consent score less than 14
  • Not taking weight loss medications or participating in another behavioral weight loss intervention
  • Mild to moderate psychiatric symptom severity as measured by the Clinical Global Impression Severity scale
  • Willing and able to provide written informed consent

Exclusion criteria:

  • Taking weight loss medications or participating in another behavioral weight loss intervention
  • University of California, San Diego Brief Assessment of Capacity to Consent score greater than or equal to 14
  • Acute suicidality at time of screening
  • Unwilling or unable to provide written informed consent

Sites / Locations

  • South Florida Behavioral Health NetworkRecruiting
  • Washington University in St. Louis Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

iOTA text messaging intervention

Health Education text messaging intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Body Mass Index
weight in kilograms/height in meters squared

Secondary Outcome Measures

Change in Self Efficacy for Healthy Eating and Exercise
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).
Change in Psychophysical Skills & Insight
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.

Full Information

First Posted
June 4, 2019
Last Updated
December 8, 2021
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03980743
Brief Title
Interactive Obesity Treatment Approach for Obesity Prevention in Adults With Early Serious Mental Illness: iOTA-SMI
Acronym
iOTA-eSMI
Official Title
Adaptation of an Evidence-based Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Early Serious Mental Illness: iOTA-eSMI
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Severe Mental Disorder
Keywords
Obesity, Overweight, Severe Mental illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iOTA text messaging intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Health Education text messaging intervention
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iOTA text messaging intervention
Other Intervention Name(s)
iOTA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education text messaging intervention
Other Intervention Name(s)
Health Ed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Mass Index
Description
weight in kilograms/height in meters squared
Time Frame
Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks
Secondary Outcome Measure Information:
Title
Change in Self Efficacy for Healthy Eating and Exercise
Description
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).
Time Frame
Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks
Title
Change in Psychophysical Skills & Insight
Description
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.
Time Frame
Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks
Other Pre-specified Outcome Measures:
Title
Percentage response rate to text prompts
Description
Treatment engagement
Time Frame
Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks
Title
Intervention feasibility, usability and acceptability as measured by the Contextual Technology Adaptation Questionnaire
Description
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.
Time Frame
Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-60 years At-risk weight defined as greater than 7 percent weight gain in the prior 2 years, overweight as evidenced by BMI 25-29.9, OR class I obesity as evidenced by BMI 30-32.49 Serious Mental Illness diagnosis Receiving case management services University of California, San Diego Brief Assessment of Capacity to Consent score less than 14 Not taking weight loss medications or participating in another behavioral weight loss intervention Mild to moderate psychiatric symptom severity as measured by the Clinical Global Impression Severity scale Willing and able to provide written informed consent Exclusion criteria: Taking weight loss medications or participating in another behavioral weight loss intervention University of California, San Diego Brief Assessment of Capacity to Consent score greater than or equal to 14 Acute suicidality at time of screening Unwilling or unable to provide written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Copher, MA
Phone
(314) 362-5939
Email
mcopher@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karen S Flavin, RN,CCRC
Phone
(314) 362-3153
Email
schweigj@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ginger Nicol, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Florida Behavioral Health Network
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Hickson
Phone
786-235-7147
Email
jhickson@sfbhn.org
First Name & Middle Initial & Last Name & Degree
John W Newcomer, MD
Facility Name
Washington University in St. Louis Medical School
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Copher, MA
Phone
314-362-5939
Email
mcopher@wustl.edu
First Name & Middle Initial & Last Name & Degree
Karen S Flavin, RN,CCRC
Phone
3147471862
Email
karen.flavin@wustl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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