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

NCT03980743 | Completed Results

• 1 other identifier: 201911123
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Overweight; Severe Mental Disorder

Keywords

Obesity; Overweight; Severe Mental illness

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  weight in kilograms/height in meters squared

  baseline and 24 weeks

Secondary Outcomes (2)

• Change in Self-Efficacy for Diet and Exercise

  Baseline and 24 weeks

• Change in Psychophysical Skills & Insight

  Baseline and 24 weeks

Study Arms (2)

iOTA text messaging intervention

ACTIVE COMPARATOR

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.

Behavioral: iOTA text messaging intervention

Health Education text messaging intervention

PLACEBO COMPARATOR

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.

Behavioral: Health Education text messaging intervention

Interventions

iOTA text messaging intervention BEHAVIORAL

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.

Also known as: iOTA

iOTA text messaging intervention

Health Education text messaging intervention BEHAVIORAL

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.

Also known as: Health Ed

Health Education text messaging intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

South Florida Behavioral Health Network

Miami, Florida, 33126, United States

Location

Washington University in St. Louis Medical School

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Nicol GE, Jansen MO, Ricchio AR, Schweiger JA, Keenoy KE, Miller JP, Morrato EH, Guo Z, Evanoff BA, Parks JJ, Newcomer JW. Adaptation of a Mobile Interactive Obesity Treatment Approach for Early Severe Mental Illness: Protocol for a Mixed Methods Implementation and Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 9;12:e42114. doi: 10.2196/42114.

  PMID: 37294604 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Mental Disorders

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ginger E. Nicol
• Organization: Washington University School of Medicine

nicolg@wustl.edu

314-747-1862

Study Officials

• Ginger Nicol, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 10, 2019
• Study Start: July 15, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: October 26, 2024
• Results First Posted: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)