Trial Outcomes & Findings for Interactive Obesity Treatment Approach for Obesity Prevention in Adults With Early Serious Mental Illness: iOTA-SMI (NCT NCT03980743)
NCT ID: NCT03980743
Last Updated: 2024-10-26
Results Overview
weight in kilograms/height in meters squared
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
baseline and 24 weeks
Results posted on
2024-10-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
17
|
|
Overall Study
COMPLETED
|
18
|
9
|
|
Overall Study
NOT COMPLETED
|
15
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Six participants withdrew their consent, and there was 1 participant missed the baseline session. A total number of 43 participants had the measures.
Baseline characteristics by cohort
| Measure |
iOTA Text Messaging Intervention
n=33 Participants
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.
|
Health Education Text Messaging Intervention
n=17 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=33 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=33 Participants
|
17 Participants
n=17 Participants
|
50 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=33 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 11.2 • n=33 Participants
|
39.8 years
STANDARD_DEVIATION 11.6 • n=17 Participants
|
37.9 years
STANDARD_DEVIATION 11.3 • n=50 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=33 Participants
|
12 Participants
n=17 Participants
|
29 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=33 Participants
|
5 Participants
n=17 Participants
|
21 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=33 Participants
|
3 Participants
n=17 Participants
|
12 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=33 Participants
|
12 Participants
n=17 Participants
|
33 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=33 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=33 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=33 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=33 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=33 Participants
|
9 Participants
n=17 Participants
|
24 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=33 Participants
|
5 Participants
n=17 Participants
|
17 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=33 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=33 Participants
|
3 Participants
n=17 Participants
|
8 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=33 Participants
|
17 Participants
n=17 Participants
|
50 Participants
n=50 Participants
|
|
Marital Status
Single
|
29 Participants
n=33 Participants
|
11 Participants
n=17 Participants
|
40 Participants
n=50 Participants
|
|
Marital Status
Married/common law
|
1 Participants
n=33 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=50 Participants
|
|
Marital Status
Divorced
|
2 Participants
n=33 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=50 Participants
|
|
Marital Status
Unknown or not reported
|
1 Participants
n=33 Participants
|
3 Participants
n=17 Participants
|
4 Participants
n=50 Participants
|
|
Employment
Employed
|
4 Participants
n=33 Participants
|
3 Participants
n=17 Participants
|
7 Participants
n=50 Participants
|
|
Employment
Unemployed
|
22 Participants
n=33 Participants
|
10 Participants
n=17 Participants
|
32 Participants
n=50 Participants
|
|
Employment
Unknown
|
7 Participants
n=33 Participants
|
4 Participants
n=17 Participants
|
11 Participants
n=50 Participants
|
|
Income
0-$25,000
|
27 Participants
n=33 Participants
|
10 Participants
n=17 Participants
|
37 Participants
n=50 Participants
|
|
Income
$25,000 - 50,000
|
4 Participants
n=33 Participants
|
2 Participants
n=17 Participants
|
6 Participants
n=50 Participants
|
|
Income
>= $100,000
|
0 Participants
n=33 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=50 Participants
|
|
Income
Unknown or not reported
|
2 Participants
n=33 Participants
|
4 Participants
n=17 Participants
|
6 Participants
n=50 Participants
|
|
Device Type
Smartphone
|
32 Participants
n=33 Participants
|
16 Participants
n=17 Participants
|
48 Participants
n=50 Participants
|
|
Device Type
Unknown or not reported
|
1 Participants
n=33 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=50 Participants
|
|
Insurance
Medicaid
|
22 Participants
n=33 Participants
|
9 Participants
n=17 Participants
|
31 Participants
n=50 Participants
|
|
Insurance
Medicare
|
3 Participants
n=33 Participants
|
3 Participants
n=17 Participants
|
6 Participants
n=50 Participants
|
|
Insurance
Commercial
|
3 Participants
n=33 Participants
|
4 Participants
n=17 Participants
|
7 Participants
n=50 Participants
|
|
Insurance
Unknown or not reported
|
5 Participants
n=33 Participants
|
1 Participants
n=17 Participants
|
6 Participants
n=50 Participants
|
|
Primary Diagnosis
Schizophrenia Spectrum
|
18 Participants
n=33 Participants
|
5 Participants
n=17 Participants
|
23 Participants
n=50 Participants
|
|
Primary Diagnosis
Bipolar Mood Disorder
|
6 Participants
n=33 Participants
|
5 Participants
n=17 Participants
|
11 Participants
n=50 Participants
|
|
Primary Diagnosis
Major Depressive Disorder
|
2 Participants
n=33 Participants
|
4 Participants
n=17 Participants
|
6 Participants
n=50 Participants
|
|
Primary Diagnosis
Anxiety
|
1 Participants
n=33 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=50 Participants
|
|
Primary Diagnosis
PTSD
|
3 Participants
n=33 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=50 Participants
|
|
Primary Diagnosis
Autism
|
1 Participants
n=33 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=50 Participants
|
|
Primary Diagnosis
Unknown or not reported
|
2 Participants
n=33 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=50 Participants
|
|
Weight (kg)
|
110.1 Kilogram
STANDARD_DEVIATION 31.0 • n=33 Participants
|
119.8 Kilogram
STANDARD_DEVIATION 34.0 • n=17 Participants
|
113.5 Kilogram
STANDARD_DEVIATION 32.0 • n=50 Participants
|
|
Body Mass Index
|
43.1 kg/m^2
STANDARD_DEVIATION 11.5 • n=33 Participants
|
38.1 kg/m^2
STANDARD_DEVIATION 10.5 • n=17 Participants
|
39.8 kg/m^2
STANDARD_DEVIATION 11.0 • n=50 Participants
|
|
9-item Patient Health Questionnaire (PHQ-9)
|
6.18 units on a scale
STANDARD_DEVIATION 6.40 • n=28 Participants • Six participants withdrew their consent, and there was 1 participant missed the baseline session. A total number of 43 participants had the measures.
|
7.73 units on a scale
STANDARD_DEVIATION 8.36 • n=15 Participants • Six participants withdrew their consent, and there was 1 participant missed the baseline session. A total number of 43 participants had the measures.
|
6.72 units on a scale
STANDARD_DEVIATION 7.09 • n=43 Participants • Six participants withdrew their consent, and there was 1 participant missed the baseline session. A total number of 43 participants had the measures.
|
|
Self-efficacy for Diet & Exercise
|
116.67 units on a scale
STANDARD_DEVIATION 29.53 • n=27 Participants • 6 participants withdrew consents, and 2 participants missed the baseline session
|
124.27 units on a scale
STANDARD_DEVIATION 19.31 • n=15 Participants • 6 participants withdrew consents, and 2 participants missed the baseline session
|
119.38 units on a scale
STANDARD_DEVIATION 26.34 • n=42 Participants • 6 participants withdrew consents, and 2 participants missed the baseline session
|
|
Loss of Control Over Eating Scale (LOCES)
|
15.1 units on a scale
STANDARD_DEVIATION 8.2 • n=28 Participants • Six participants withdrew their consent, and there was 1 participant missed the baseline session. A total number of 43 participants had the measures.
|
15.9 units on a scale
STANDARD_DEVIATION 7.8 • n=15 Participants • Six participants withdrew their consent, and there was 1 participant missed the baseline session. A total number of 43 participants had the measures.
|
15.4 units on a scale
STANDARD_DEVIATION 7.9 • n=43 Participants • Six participants withdrew their consent, and there was 1 participant missed the baseline session. A total number of 43 participants had the measures.
|
PRIMARY outcome
Timeframe: baseline and 24 weeksPopulation: All participants have baseline measurements; only 18 iOTA participants and 9 participants in the Education group completed the 24-week follow-up.
weight in kilograms/height in meters squared
Outcome measures
| Measure |
iOTA Text Messaging Intervention
n=33 Participants
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.
|
Health Education Text Messaging Intervention
n=17 Participants
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.
|
|---|---|---|
|
Body Mass Index
baseline
|
43.1 kg/m^2
Standard Deviation 11.5
|
38.1 kg/m^2
Standard Deviation 10.5
|
|
Body Mass Index
week24_endpoint
|
40.3 kg/m^2
Standard Deviation 13.3
|
40.3 kg/m^2
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
iOTA Text Messaging Intervention
n=15 Participants
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.
|
Health Education Text Messaging Intervention
n=28 Participants
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.
|
|---|---|---|
|
Change in Self-Efficacy for Diet and Exercise
baseline
|
124.27 score on a scale
Standard Error 4.99
|
116.67 score on a scale
Standard Error 5.68
|
|
Change in Self-Efficacy for Diet and Exercise
24 weeks
|
131.71 score on a scale
Standard Error 9.45
|
109.67 score on a scale
Standard Error 11.82
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Time X treatment (0 and 24 weeks) with sum of the score
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.
Outcome measures
| Measure |
iOTA Text Messaging Intervention
n=15 Participants
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.
|
Health Education Text Messaging Intervention
n=28 Participants
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.
|
|---|---|---|
|
Change in Psychophysical Skills & Insight
baseline
|
34.93 score on a scale
Standard Error 1.56
|
33.36 score on a scale
Standard Error 1.02
|
|
Change in Psychophysical Skills & Insight
24 weeks
|
38.43 score on a scale
Standard Error 2.20
|
35.50 score on a scale
Standard Error 2.31
|
Adverse Events
iOTA Text Messaging Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education Text Messaging Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ginger E. Nicol
Washington University School of Medicine
Phone: 314-747-1862
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place