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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02626819
Date of registration: 29/09/2015
Prospective Registration: No
Primary sponsor: VA Office of Research and Development
Public title: Improving Weight Management at the VA
Scientific title: Improving Weight Management at VA: Enhancing the MOVE!23 for Primary Care (CDA 10-206)
Date of first enrolment: August 3, 2015
Target sample size: 45
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02626819
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Double (Participant, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Melanie R. Jay, MD MS
Address: 
Telephone:
Email:
Affiliation:  Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Key inclusion & exclusion criteria

Inclusion Criteria:

- Has not participated in MOVE! in the past year

- Age 18-69 (this age range represents MOVE! eligibility)

- BMI of 30kg/m2 or a BMI of 25 kg/m2 with obesity-associated condition

- Under the care of PCP with at least 1 prior visit with the provider in the past 12
months

- Access to a telephone

- Able to travel to Brooklyn or Manhattan VA for in-person evaluations at 3, 6, and 12
months

Exclusion Criteria:

- Non-Veterans

- A documented current history of active psychosis or other cognitive issues via
International Classification of Diseases (ICD-9) codes

- Diabetes diagnosis via ICD-9 code

- Primary care provider recommends that the patient should not participate

- Severe arthritis, valvular disease, cardiac arrhythmia, pregnancy, and/or other
conditions (indicated by PCP) limiting moderate PA

- Self-reported inability to read at a 5th grade level due to literacy level or vision
problems



Age minimum: 18 Years
Age maximum: 69 Years
Gender: All
Health Condition(s) or Problem(s) studied
Obesity
Intervention(s)
Behavioral: Enhanced Usual Care
Behavioral: MOVE! Toward Your Goals
Primary Outcome(s)
Percent of Patients With 2.5% Weight Loss at 6 Months. [Time Frame: 6 months]
Weight Change (kg) [Time Frame: 3 Months]
Percent of Patients With Clinically Significant Weight Loss [Time Frame: 12 months]
Percent of Patients With Clinically Significant Weight Loss [Time Frame: 6 months]
Percent of Patients With Clinically Significant Weight Loss [Time Frame: 3 months]
Percent of Patients Who Achieved 2.5% Weight Loss [Time Frame: 12 months]
Weight Change (kg) [Time Frame: 12 months]
Weight Change (kg) [Time Frame: 6 Months]
Secondary Outcome(s)
Secondary ID(s)
CDP 12-252
CDA 10-206
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 21/12/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02626819
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