N/A
Completed N=45
Improving Weight Management at the VA
Source: ClinicalTrials.gov NCT02626819 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Weight Change (kg) — -1.06; 0.07 kilograms — p=<0.05
Summary
Compared to the general public, a higher percentage of Veterans are obese or overweight with a weight-related medical condition. The VA currently offers an effective weight management program called MOVE!, but the majority of eligible patients do not attend. Veterans see their primary care providers (PCPs) very frequently, making it an important place to receive information on weight management. However, PCPs often fail to discuss weight management with patients, so interventions are needed to encourage weight management counseling within the team-based care model used in primary care at the VA. Investigators used focus groups, interviews, and other research methods to develop the MOVE! Toward Your Goals (MTG) intervention. This intervention combines online tools, counseling by a health coach, and the team-based care model to deliver weight management information to patients.
Investigators will conduct a randomized controlled trial of 320 Veteran patients and their providers at two VA sites (Manhattan and Brooklyn campuses, New York Harbor Healthcare System) to study the impact of the 12-month MTG intervention when compared to Enhanced Usual Care. Veterans in the MTG intervention arm will take the MTG tool, receive personalized weight management materials, health coach counseling, and go to their scheduled primary care (PC) visit. After the initial visit, MTG-arm Veterans will receive follow up telephone coaching over 12 months. All Veterans will attend follow-up visits at 3, 6 and 12 months to assess body mass index, diet and physical activity, and goal attainment.
The objectives of this study are to: (a) test the impact of the MTG intervention on weight and behavior changes; (b) identify predictors of weight loss in Veterans who use goal setting techniques; and (c) determine the impact of the MTG intervention on primary care team obesity-related counseling practices and attitudes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change (kg) |
-1.02; 0.74 | <0.05 sig |
| PRIMARY Percent of Patients With Clinically Significant Weight Loss |
2; 3 | <0.05 sig |
| PRIMARY Percent of Patients With 2.5% Weight Loss at 6 Months. |
7; 5 | <0.05 sig |
| PRIMARY Percent of Patients Who Achieved 2.5% Weight Loss |
5; 4 | <0.05 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02626819). 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.