NCT02626819

Improving Weight Management at the VA

Completed NA Results posted Last updated 21 December 2018

What this trial tests

NA trial testing MOVE! Toward Your Goals in Obesity in 45 participants. Completed in 5 March 2018.

Timeline

3 August 2015

Primary endpoint
31 May 2017

5 March 2018

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	45
Start date	3 August 2015
Primary completion	31 May 2017
Estimated completion	5 March 2018
Sites	2 locations across United States

Drugs / interventions tested

• MOVE! Toward Your Goals
• Enhanced Usual Care

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 69, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Weight Change (kg) Primary · 3 Months

Weight Change from baseline to 3 months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.

Group	Value	95% CI
Arm 1: Receiving MOVE! Toward Your Goals	-1.06	± 1.72
Arm 2: Receiving Enhanced Usual Care	0.07	± 2.40

Weight Change (kg) Primary · 6 Months

Change in weight from baseline to 6-months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.

Group	Value	95% CI
Arm 1: Receiving MOVE! Toward Your Goals	-1.52	± 3.06
Arm 2: Receiving Enhanced Usual Care	0.23	± 3.64

Weight Change (kg) Primary · 12 months

Change in weight from baseline to the 12-months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.

Group	Value	95% CI
Arm 1: Receiving MOVE! Toward Your Goals	-1.02	± 4.16
Arm 2: Receiving Enhanced Usual Care	0.74	± 4.90

Percent of Patients With Clinically Significant Weight Loss Primary · 3 months

The percentage of patients who achieve 5-10% weight loss at 3- month study visit.

Group	Value	95% CI
Arm 1: Receiving MOVE! Toward Your Goals	1
Arm 2: Receiving Enhanced Usual Care	2

Percent of Patients With 2.5% Weight Loss at 6 Months. Primary · 6 months

Percentage of patients who achieved 2.5% weight loss at 6 months. Weight measured in kg.

Group	Value	95% CI
Arm 1: Receiving MOVE! Toward Your Goals	7
Arm 2: Receiving Enhanced Usual Care	5

Percent of Patients With Clinically Significant Weight Loss Primary · 6 months

The percentage of patients who achieve 5-10% weight loss at 6- month study visit.

Group	Value	95% CI
Arm 1: Receiving MOVE! Toward Your Goals	2
Arm 2: Receiving Enhanced Usual Care	1

Percent of Patients Who Achieved 2.5% Weight Loss Primary · 12 months

Percentage of patients who achieved 2.5% weight loss at 12 months. Weight measured in kg.

Group	Value	95% CI
Arm 1: Receiving MOVE! Toward Your Goals	5
Arm 2: Receiving Enhanced Usual Care	4

Percent of Patients With Clinically Significant Weight Loss Primary · 12 months

The percentage of patients who achieve 5-10% weight loss at 12- month study visit.

Group	Value	95% CI
Arm 1: Receiving MOVE! Toward Your Goals	2
Arm 2: Receiving Enhanced Usual Care	3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.