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

Not Applicable

Completed

• Conditions: Overweight; Severe Mental Disorder; Obesity
• Interventions: Behavioral: Health Education text messaging intervention; Behavioral: iOTA text messaging intervention

• Registration Number: NCT03980743
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Study Start: 2020-07-15
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Results First Submitted: 2023-01-23
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-23
• Last Update Submitted: 2024-10-23
• Results First Posted: 2024-10-26
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Education text messaging intervention	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.
iOTA text messaging intervention	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.

Primary Outcome Measures

Name	Time	Method
Body Mass Index	baseline and 24 weeks	weight in kilograms/height in meters squared

Secondary Outcome Measures

Name	Time	Method
Change in Self-Efficacy for Diet and Exercise	Baseline and 24 weeks	This questionnaire includes 32 questions in two domains of self efficacy: 1) healthy eating and 2) exercise.; Within it, there are 20 questions about the eating habits sub-scale and 12 questions about the exercise habits sub-scale.; 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).; A total score is reported with a range of 32 to 160, where a lower score represents worse overall eating and exercise habits.; Total scores is measured at baseline and 24 weeks follow-up.
Change in Psychophysical Skills & Insight	Baseline and 24 weeks	This questionnaire includes 10 questions, with three separate subscales: 1)Self-determination, 2)Cognitive control and 3)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. Total score is from 10-50.; Higher scores indicate greater degree of psychophysical awareness \& skills.

Trial Locations

Locations (2)

South Florida Behavioral Health Network; 🇺🇸 Miami, Florida, United States

Washington University in St. Louis Medical School; 🇺🇸 Saint Louis, Missouri, United States