Clinical trial NCT03980743: Interactive Obesity Treatment Approach for Obesity Prevention in Adults With Early Serious Mental Illness: iOTA-SMI
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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Severe Mental Disorder
Keywords: Obesity
Overweight
Severe Mental illness
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body Mass Index
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: Change in Self-Efficacy for Diet and Exercise
timeFrame: Baseline and 24 weeks
measure: Change in Psychophysical Skills & Insight
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Florida Behavioral Health Network
state: Florida
city: Saint Louis
country: United States
facility: Washington University in St. Louis Medical School
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ginger Nicol, MD
role: PRINCIPAL_INVESTIGATOR
References: