Main
|
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: |
|
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 ID(s)
|
CDP 12-252
|
CDA 10-206
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
|