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iOTA text messaging intervention for Obesity (iOTA-eSMI Trial)

N/A
Waitlist Available
Led By Ginger Nicol, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4, 8, 12, 16, 20, 24 and 36 weeks
Awards & highlights

iOTA-eSMI Trial Summary

This study is evaluating whether a text message based program may help prevent obesity in individuals with serious mental illness.

Eligible Conditions
  • Obesity
  • Mental Disorders

iOTA-eSMI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

iOTA-eSMI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4, 8, 12, 16, 20, 24 and 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4, 8, 12, 16, 20, 24 and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Body Mass Index
Secondary outcome measures
Change in Psychophysical Skills & Insight
Change in Self Efficacy for Healthy Eating and Exercise
Other outcome measures
Intervention feasibility, usability and acceptability as measured by the Contextual Technology Adaptation Questionnaire
Percentage response rate to text prompts

iOTA-eSMI Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: iOTA text messaging interventionActive Control1 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.
Group II: Health Education text messaging interventionPlacebo Group1 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.

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,028 Total Patients Enrolled
77 Trials studying Obesity
13,757 Patients Enrolled for Obesity
Ginger Nicol, MDPrincipal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
349 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~13 spots leftby Mar 2025