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

Obesity Clinical Trial

— iOTA-eSMI  

Official title:

Adaptation of an Evidence-based Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Early Serious Mental Illness: iOTA-eSMI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03980743
• Other study ID #: 201911123
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: December 2021
• Source: Washington University School of Medicine
• Contact: Matthew Copher, MA
• Phone: (314) 362-5939
• Email: mcopher[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Obesity
• Overweight
• Severe Mental Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	South Florida Behavioral Health Network	Miami	Florida
United States	Washington University in St. Louis Medical School	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage response rate to text prompts	Treatment engagement	Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks
Other	Intervention feasibility, usability and acceptability as measured by the Contextual Technology Adaptation Questionnaire	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.	Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks
Primary	Change in Body Mass Index	weight in kilograms/height in meters squared	Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks
Secondary	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).	Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks
Secondary	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.	Baseline, 4, 8, 12, 16, 20, 24 and 36 weeks