Obesity Clinical Trial
— iOTA-eSMIOfficial title:
Adaptation of an Evidence-based Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Early Serious Mental Illness: iOTA-eSMI
NCT number | NCT03980743 |
Other study ID # | 201911123 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 15, 2020 |
Est. completion date | May 31, 2022 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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 |
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