Improving Obesity Self-Care Among Mentally Ill Veterans

NCT02642536 | Completed Results

• 1 other identifier: D7886-W
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Depression; PTSD; Obesity

Keywords

Veteran

Outcome Measures

Primary Outcomes (5)

• MOVE! Attendance

  Number of MOVE! sessions attended minimum-maximum total score range (2-12) Higher value represents more sessions attended The score was obtained from a single item

  16 weeks

• Number of Days Engaged in Vigorous Activity

  changes in vigor and time spent on physical activity practice will be measured by the MOVE! 11 assessment at post treatment (16 weeks) minimum-maximum total score range (0-48) Higher value represents more days spent performing vigorous activity

  16 weeks

• Number of Days Engaged in Vigorous Activity

  Initial assessment of vigor and time spent on physical activity minimum-maximum total score range (0-32) Higher value represents more days spent performing vigorous physical activity The score was obtained from a single item

  baseline

• Self Efficacy for Practicing Good Dietary Habits

  Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales

  baseline

• Self Efficacy for Practicing Good Dietary Habits

  Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales

  16 weeks

Secondary Outcomes (6)

• Assessing Depression Symptom Severity

  16 weeks

• Assessing Anxiety Symptom Severity

  16 weeks

• Assessing PTSD Symptom Severity

  16 weeks

• Assessing Depression Symptom Severity

  baseline

• Assessing Anxiety Symptom Severity

  baseline

Study Arms (2)

MH MOVE

ACTIVE COMPARATOR

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

Behavioral: MH MOVE

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care

Interventions

MH MOVE BEHAVIORAL

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

MH MOVE

Enhanced Usual Care BEHAVIORAL

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Obesity

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Gina Evans
• Organization: VA

gina.evans@va.gov

713-440-4459

Study Officials

• Gina Evans, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking was Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 30, 2015
• Study Start: January 1, 2011
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: February 22, 2018
• Results First Posted: August 7, 2017

Record last verified: 2018-01

Locations

US (1)