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NCT Number: NCT03980743

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

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.

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Key information

Conditions

Obesity Body Weight Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Severe Mental Disorder Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Florida Behavioral Health Network, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: iOTA

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.

Other names: Health Ed

Primary outcomes

  1. Body Mass Index

    Time frame: baseline and 24 weeks

    weight in kilograms/height in meters squared

Secondary outcomes

  1. Change in Self-Efficacy for Diet and Exercise

    Time frame: Baseline and 24 weeks

    This questionnaire includes 32 questions in two domains of self efficacy: 1) healthy eating and 2) exercise.

    Within it, there are 20 questions about the eating habits sub-scale and 12 questions about the exercise habits sub-scale.

    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).

    A total score is reported with a range of 32 to 160, where a lower score represents worse overall eating and exercise habits.

    Total scores is measured at baseline and 24 weeks follow-up.

  2. Change in Psychophysical Skills & Insight

    Time frame: Baseline and 24 weeks

    This questionnaire includes 10 questions, with three separate subscales: 1)Self-determination, 2)Cognitive control and 3)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. Total score is from 10-50.

    Higher scores indicate greater degree of psychophysical awareness & skills.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: iOTA-eSMI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2019
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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