N/A
Completed N=50
Interactive Obesity Treatment Approach for Obesity Prevention in Adults With Early Serious Mental Illness: iOTA-SMI
Obesity · Overweight · Severe Mental Disorder
Source: ClinicalTrials.gov NCT03980743 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Body Mass Index — 43.1; 38.1; 40.3; 40.3 kg/m^2 — p=0.97
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Mass Index |
43.1; 38.1; 40.3; 40.3 | 0.97 |
| SECONDARY Change in Self-Efficacy for Diet and Exercise |
124.27; 116.67; 131.71; 109.67 | 0.273 |
| SECONDARY Change in Psychophysical Skills & Insight |
34.93; 33.36; 38.43; 35.50 | 0.691 |
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
Data sourced from ClinicalTrials.gov (NCT03980743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.