Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | weight in kilograms/height in meters squared | baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Efficacy for Diet and Exercise | 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. |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ginger Nicol, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Florida Behavioral Health Network | Miami | Florida | 33126 | United States | ||
| Washington University in St. Louis Medical School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37294604 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | iOTA Text Messaging 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. iOTA text messaging intervention: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 19, 2020 | Oct 23, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
|
| Baseline and 24 weeks |
| Change in Psychophysical Skills & Insight | 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. | Baseline and 24 weeks |
| St Louis |
| Missouri |
| 63110 |
| United States |
| FG001 | Health Education Text Messaging 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. Health Education text messaging intervention: 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | iOTA Text Messaging 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. iOTA text messaging intervention: 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. |
| BG001 | Health Education Text Messaging 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. Health Education text messaging intervention: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Marital Status | Count of Participants | Participants |
| ||||||||||||||||
| Employment | Count of Participants | Participants |
| ||||||||||||||||
| Income | Count of Participants | Participants |
| ||||||||||||||||
| Device Type | Count of Participants | Participants |
| ||||||||||||||||
| Insurance | Count of Participants | Participants |
| ||||||||||||||||
| Primary Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Weight (kg) | Mean | Standard Deviation | Kilogram |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| 9-item Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire is a 9-item scale that assessed overall depression. A total score is reported with a range of 0 to 27, where a higher score represents worse overall depression. | Six participants withdrew their consent, and there was 1 participant missed the baseline session. A total number of 43 participants had the measures. | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Self-efficacy for Diet & Exercise | This measure consists of 32 questions that assess over eating and exercise habits. Within it, there are 20 questions about the eating habits sub-scale and 12 questions about the exercise habits sub-scale. A total score is reported with a range of 32 to 160, where a lower score represents worse overall eating and exercise habits. | 6 participants withdrew consents, and 2 participants missed the baseline session | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Loss of Control Over Eating Scale (LOCES) | Six participants withdrew their consent, and there was 1 participant missed the baseline session. A total number of 43 participants had the measures. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Mass Index | weight in kilograms/height in meters squared | All participants have baseline measurements; only 18 iOTA participants and 9 participants in the Education group completed the 24-week follow-up. | Posted | Mean | Standard Deviation | kg/m^2 | baseline and 24 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Self-Efficacy for Diet and Exercise | 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. | One patient missed/ skipped this session in iOTA group at baseline; Only 7 participants in Education group and 9 iOTA participant completed the 24 weeks follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline and 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Psychophysical Skills & Insight | 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. | Time X treatment (0 and 24 weeks) with sum of the score | Posted | Mean | Standard Error | score on a scale | Baseline and 24 weeks |
|
The time frame is until the study's completion, an average of 6 months.
No AEs/SAEs occurred through the study completion.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iOTA Text Messaging 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. iOTA text messaging intervention: 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. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG001 | Health Education Text Messaging 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. Health Education text messaging intervention: 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. | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ginger E. Nicol | Washington University School of Medicine | 314-747-1862 | nicolg@wustl.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2020 | Dec 14, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 14, 2022 | Dec 8, 2022 | ICF_002.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| week24_endpoint |
|
|
| OG001 | iOTA Text Messaging 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. iOTA text messaging intervention: 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. |
|
|
|
| OG001 | iOTA Text Messaging 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. iOTA text messaging intervention: 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. |
|
|
|