N/A
Completed N=44
Improving Obesity Self-Care Among Mentally Ill Veterans
Source: ClinicalTrials.gov NCT02642536 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: MOVE! Attendance — 5.9; 5.8 number of sessions
Summary
The purpose of this study is to find out which of two programs, MH MOVE! or the enhanced usual care MOVE! program is most effective in improving participation in and completion of MOVE! among Veterans with depression, anxiety, and PTSD. One of the treatments, MH MOVE! provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 10 phone based clinician led CBT sessions. The enhanced usual care MOVE! provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MOVE! Attendance |
5.9; 5.8 | — |
| PRIMARY Number of Days Engaged in Vigorous Activity |
27.7; 28.1 | — |
| PRIMARY Self Efficacy for Practicing Good Dietary Habits |
29.9; 23.2 | — |
| SECONDARY Assessing Depression Symptom Severity |
19; 15 | — |
| SECONDARY Assessing Anxiety Symptom Severity |
8; 16 | — |
| SECONDARY Assessing PTSD Symptom Severity |
39; 25 | — |
Eligibility Criteria
Inclusion Criteria
- Eligible participants will be Veterans over 18 years of age who are overweight or obese as indicated by a BMI greater than 30.
- Participants who are enrolled have never participated in the MOVE! program and are joining the MOVE! program for the first time.
- Severity of potential co-existing anxiety and depression will be assessed by a diagnosis of PTSD, anxiety and depression noted in the medical history and will be confirmed using the PTSD Checklist (PCL-C), Patient Health Questionnaire (PHQ-8), Generalized Anxiety 7-item Scale (GAD-7).
- Participants who endorse mild-to-moderate depression characterized by a scores in the range of 5-19 on the PHQ-8, scores ranging from 5-14 on the GAD-7 scale and scores 6-50 on the PCL.
Exclusion Criteria
- Participants will be excluded if they have a medical diagnosis of schizophrenia or bi-polar
- Have symptom checklist score in the severe range of anxiety, depression or PTSD
- Demonstrate suicidal/homicidal plan and intent
- And/or demonstrate moderate or severe cognitive impairment as demonstrated by the cognitive status screener
- Do not have regular access to a telephone
- Are no longer obese as established by calculation of current BMI
- Or are no longer endorsing any symptoms of anxiety or depression as established by a score of less than 5 (due to lack of depressive symptoms) and those greater than 19 (due to severity of depressive symptoms) on the PHQ-8 and less than 5 (indicating no presence of anxiety) and greater than 15 (indicating severe anxiety) on the GAD-7 less than 6 (indicating no presence of PTSD symptoms) and greater than 50 (severe PTSD) on the PCL.
Data sourced from ClinicalTrials.gov (NCT02642536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.