Obesity, Overweight, Severe Mental Disorder
Conditions
Keywords
Obesity, Overweight, Severe Mental illness
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.
Detailed description
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.
Interventions
BEHAVIORALiOTA 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.
BEHAVIORALHealth 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | baseline and 24 weeks | weight in kilograms/height in meters squared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Efficacy for Diet and Exercise | 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. |
| Change in Psychophysical Skills & Insight | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| 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. | 17 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | iOTA Text Messaging Intervention | Health Education Text Messaging Intervention |
|---|---|---|---|
| 9-item Patient Health Questionnaire (PHQ-9) | 6.72 units on a scale STANDARD_DEVIATION 7.09 | 6.18 units on a scale STANDARD_DEVIATION 6.4 | 7.73 units on a scale STANDARD_DEVIATION 8.36 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 33 Participants | 17 Participants |
| Age, Continuous | 37.9 years STANDARD_DEVIATION 11.3 | 36.9 years STANDARD_DEVIATION 11.2 | 39.8 years STANDARD_DEVIATION 11.6 |
| Body Mass Index | 39.8 kg/m^2 STANDARD_DEVIATION 11 | 43.1 kg/m^2 STANDARD_DEVIATION 11.5 | 38.1 kg/m^2 STANDARD_DEVIATION 10.5 |
| Device Type Smartphone | 48 Participants | 32 Participants | 16 Participants |
| Device Type Unknown or not reported | 2 Participants | 1 Participants | 1 Participants |
| Employment Employed | 7 Participants | 4 Participants | 3 Participants |
| Employment Unemployed | 32 Participants | 22 Participants | 10 Participants |
| Employment Unknown | 11 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 9 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 21 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 2 Participants |
| Income 0-$25,000 | 37 Participants | 27 Participants | 10 Participants |
| Income >= $100,000 | 1 Participants | 0 Participants | 1 Participants |
| Income $25,000 - 50,000 | 6 Participants | 4 Participants | 2 Participants |
| Income Unknown or not reported | 6 Participants | 2 Participants | 4 Participants |
| Insurance Commercial | 7 Participants | 3 Participants | 4 Participants |
| Insurance Medicaid | 31 Participants | 22 Participants | 9 Participants |
| Insurance Medicare | 6 Participants | 3 Participants | 3 Participants |
| Insurance Unknown or not reported | 6 Participants | 5 Participants | 1 Participants |
| Loss of Control Over Eating Scale (LOCES) | 15.4 units on a scale STANDARD_DEVIATION 7.9 | 15.1 units on a scale STANDARD_DEVIATION 8.2 | 15.9 units on a scale STANDARD_DEVIATION 7.8 |
| Marital Status Divorced | 3 Participants | 2 Participants | 1 Participants |
| Marital Status Married/common law | 3 Participants | 1 Participants | 2 Participants |
| Marital Status Single | 40 Participants | 29 Participants | 11 Participants |
| Marital Status Unknown or not reported | 4 Participants | 1 Participants | 3 Participants |
| Primary Diagnosis Anxiety | 1 Participants | 1 Participants | 0 Participants |
| Primary Diagnosis Autism | 1 Participants | 1 Participants | 0 Participants |
| Primary Diagnosis Bipolar Mood Disorder | 11 Participants | 6 Participants | 5 Participants |
| Primary Diagnosis Major Depressive Disorder | 6 Participants | 2 Participants | 4 Participants |
| Primary Diagnosis PTSD | 5 Participants | 3 Participants | 2 Participants |
| Primary Diagnosis Schizophrenia Spectrum | 23 Participants | 18 Participants | 5 Participants |
| Primary Diagnosis Unknown or not reported | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 15 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 17 Participants | 12 Participants | 5 Participants |
| Region of Enrollment United States | 50 Participants | 33 Participants | 17 Participants |
| Self-efficacy for Diet & Exercise | 119.38 units on a scale STANDARD_DEVIATION 26.34 | 116.67 units on a scale STANDARD_DEVIATION 29.53 | 124.27 units on a scale STANDARD_DEVIATION 19.31 |
| Sex: Female, Male Female | 29 Participants | 17 Participants | 12 Participants |
| Sex: Female, Male Male | 21 Participants | 16 Participants | 5 Participants |
| Weight (kg) | 113.5 Kilogram STANDARD_DEVIATION 32 | 110.1 Kilogram STANDARD_DEVIATION 31 | 119.8 Kilogram STANDARD_DEVIATION 34 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 17 |
| other Total, other adverse events | 0 / 33 | 0 / 17 |
| serious Total, serious adverse events | 0 / 33 | 0 / 17 |
Outcome results
Primary
Body Mass Index
weight in kilograms/height in meters squared
Time frame: baseline and 24 weeks
Population: All participants have baseline measurements; only 18 iOTA participants and 9 participants in the Education group completed the 24-week follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iOTA Text Messaging Intervention | Body Mass Index | week24_endpoint | 40.3 kg/m^2 | Standard Deviation 13.3 |
| iOTA Text Messaging Intervention | Body Mass Index | baseline | 43.1 kg/m^2 | Standard Deviation 11.5 |
| Health Education Text Messaging Intervention | Body Mass Index | week24_endpoint | 40.3 kg/m^2 | Standard Deviation 9.3 |
| Health Education Text Messaging Intervention | Body Mass Index | baseline | 38.1 kg/m^2 | Standard Deviation 10.5 |
Comparison: Time x treatment (week 0 and week 24)p-value: 0.97Mixed Models Analysis
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 frame: Baseline and 24 weeks
Population: Time X treatment (0 and 24 weeks) with sum of the score
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iOTA Text Messaging Intervention | Change in Psychophysical Skills & Insight | baseline | 34.93 score on a scale | Standard Error 1.56 |
| iOTA Text Messaging Intervention | Change in Psychophysical Skills & Insight | 24 weeks | 38.43 score on a scale | Standard Error 2.2 |
| Health Education Text Messaging Intervention | Change in Psychophysical Skills & Insight | baseline | 33.36 score on a scale | Standard Error 1.02 |
| Health Education Text Messaging Intervention | Change in Psychophysical Skills & Insight | 24 weeks | 35.50 score on a scale | Standard Error 2.31 |
p-value: 0.691Mixed Models Analysis
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.
Time frame: Baseline and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iOTA Text Messaging Intervention | Change in Self-Efficacy for Diet and Exercise | baseline | 124.27 score on a scale | Standard Error 4.99 |
| iOTA Text Messaging Intervention | Change in Self-Efficacy for Diet and Exercise | 24 weeks | 131.71 score on a scale | Standard Error 9.45 |
| Health Education Text Messaging Intervention | Change in Self-Efficacy for Diet and Exercise | baseline | 116.67 score on a scale | Standard Error 5.68 |
| Health Education Text Messaging Intervention | Change in Self-Efficacy for Diet and Exercise | 24 weeks | 109.67 score on a scale | Standard Error 11.82 |
Comparison: Time x treatment (week 0 and week 24) for Healthy Eatingp-value: 0.273Mixed Models Analysis