Obesity
Conditions
Keywords
Obesity, Weight Management, Primary Care, Health Coach, iPad, Goal Setting, 5As, technology
Brief 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.
Detailed description
Veterans shoulder a disproportionate burden of obesity and its co-morbidities, including diabetes, hypertension, and hyperlipidemia. Modest weight loss in obese patients through diet and exercise improves health and prevents chronic disease, but primary care providers (PCPs) often fail to adequately counsel patients about their weight due to lack of time and training. Thus, tools and brief interventions are needed to support providers' behavior change counseling. The VA currently offers the MOVE! program to treat overweight and obese patients, but only 9% of eligible patients attend. At the same time, Veterans on average see their PCPs 3.6 times per year, which supports the importance of developing primary care (PC)-based interventions. The United States Preventive Services Task force (USPSTF) recommends the use of the 5As framework (Assess, Advise, Agree, Assist, Arrange \[5A\]) for counseling patients about weight. Interactive behavior change technologies utilizing expert system software programs are an innovative way to facilitate 5As counseling to promote behavior change in primary care. These programs perform computerized risk, lifestyle, and theory- based, behavioral assessment to provide computer-generated, tailored advice to patients. They also can provide information to healthcare teams. Collaborative goal setting can be used to achieve behavior change in this intervention. This construct, a critical component of several behavior change theories and models and corresponding to agree in the 5As model, has been widely recommended for health promotion in primary care. Investigators did formative work using key informant interviews with several VA Patient Aligned Care Teams (PACT), MOVE! staff, and focus groups with Veterans demonstrated that goal setting is feasible and acceptable to patients and PACT teamlets, and provided insight on barriers to goal setting, and ways to facilitate goal-setting conversations. During the development phase of this project, investigators developed a primary care-based intervention called MOVE! Toward Your Goals (MTG) to facilitate weight management within primary care and increase adoption of intensive VA programs such as MOVE!. The MTG intervention uses a new MTG software tool (that the investigators developed) delivered on tablets to facilitate 5As-based weight management counseling with a health coach and healthcare team to promote goal-setting, behavior change, and weight loss in the primary care setting. The Veteran also receives follow up with 12 health coaching calls over 1 year. Investigators will conduct a large, multicenter (Manhattan and Brooklyn campuses, New York Harbor Healthcare System) randomized controlled trial of 320 subjects, who will be randomized to receive either Enhanced Usual Care or the MTG Intervention. 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.
Interventions
BEHAVIORALMOVE! Toward Your Goals
Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members
BEHAVIORALEnhanced Usual Care
Patients will be given information on healthy living messages that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinded to intervention arm
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change (kg) | 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. |
| Percent of Patients With Clinically Significant Weight Loss | 3 months | The percentage of patients who achieve 5-10% weight loss at 3- month study visit. |
| Percent of Patients With 2.5% Weight Loss at 6 Months. | 6 months | Percentage of patients who achieved 2.5% weight loss at 6 months. Weight measured in kg. |
| Percent of Patients Who Achieved 2.5% Weight Loss | 12 months | Percentage of patients who achieved 2.5% weight loss at 12 months. Weight measured in kg. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Receiving MOVE! Toward Your Goals Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)
MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members | 22 |
| Arm 2: Receiving Enhanced Usual Care Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider)
Enhanced Usual Care: Patients will be given information on healthy living messages that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling. | 23 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Diagnosed w/ catastrophic illness | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Arm 1: Receiving MOVE! Toward Your Goals | Arm 2: Receiving Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 19 Participants | 37 Participants |
| Age, Continuous | 53.29 years STANDARD_DEVIATION 10.37 | 56.14 years STANDARD_DEVIATION 10.73 | 54.74 years STANDARD_DEVIATION 10.53 |
| Body Mass Index (BMI) | 30.7 kg/m2 STANDARD_DEVIATION 3.4 | 33.0 kg/m2 STANDARD_DEVIATION 5.8 | 31.8 kg/m2 STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 15 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 11 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 0 / 22 | 0 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 |
Outcome results
Primary
Percent of Patients Who Achieved 2.5% Weight Loss
Percentage of patients who achieved 2.5% weight loss at 12 months. Weight measured in kg.
Time frame: 12 months
Population: At the 12-months, 3 participants in Arm 1 and 2 participants in Arm 2 did not complete the study visit and thus were not included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Receiving MOVE! Toward Your Goals | Percent of Patients Who Achieved 2.5% Weight Loss | 5 Participants |
| Arm 2: Receiving Enhanced Usual Care | Percent of Patients Who Achieved 2.5% Weight Loss | 4 Participants |
p-value: <0.05Fisher Exact
Primary
Percent of Patients With 2.5% Weight Loss at 6 Months.
Percentage of patients who achieved 2.5% weight loss at 6 months. Weight measured in kg.
Time frame: 6 months
Population: At the 6-months, 2 participants in Arm 1 and 1 participant in Arm 2 did not complete the study visit and thus were not included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Receiving MOVE! Toward Your Goals | Percent of Patients With 2.5% Weight Loss at 6 Months. | 7 Participants |
| Arm 2: Receiving Enhanced Usual Care | Percent of Patients With 2.5% Weight Loss at 6 Months. | 5 Participants |
p-value: <0.05Fisher Exact
Primary
Percent of Patients With Clinically Significant Weight Loss
The percentage of patients who achieve 5-10% weight loss at 12- month study visit.
Time frame: 12 months
Population: At the 12-months, 3 participants in Arm 1 and 2 participants in Arm 2 did not complete the study visit and thus were not included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Receiving MOVE! Toward Your Goals | Percent of Patients With Clinically Significant Weight Loss | 2 Participants |
| Arm 2: Receiving Enhanced Usual Care | Percent of Patients With Clinically Significant Weight Loss | 3 Participants |
p-value: <0.05Fisher Exact
Primary
Percent of Patients With Clinically Significant Weight Loss
The percentage of patients who achieve 5-10% weight loss at 3- month study visit.
Time frame: 3 months
Population: At the 3-months, 6 participants in Arm 1 did not complete the study visits and thus were not included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Receiving MOVE! Toward Your Goals | Percent of Patients With Clinically Significant Weight Loss | 1 Participants |
| Arm 2: Receiving Enhanced Usual Care | Percent of Patients With Clinically Significant Weight Loss | 2 Participants |
p-value: <0.05Fisher Exact
Primary
Percent of Patients With Clinically Significant Weight Loss
The percentage of patients who achieve 5-10% weight loss at 6- month study visit.
Time frame: 6 months
Population: At the 6-months, 2 participants in Arm 1 and 1 participant in Arm 2 did not complete the study visit and thus were not included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Receiving MOVE! Toward Your Goals | Percent of Patients With Clinically Significant Weight Loss | 2 Participants |
| Arm 2: Receiving Enhanced Usual Care | Percent of Patients With Clinically Significant Weight Loss | 1 Participants |
p-value: <0.05Fisher Exact
Primary
Weight Change (kg)
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.
Time frame: 3 Months
Population: Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputations to adjust for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Receiving MOVE! Toward Your Goals | Weight Change (kg) | -1.06 kilograms | Standard Deviation 1.72 |
| Arm 2: Receiving Enhanced Usual Care | Weight Change (kg) | 0.07 kilograms | Standard Deviation 2.4 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Weight Change (kg)
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.
Time frame: 6 Months
Population: Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Receiving MOVE! Toward Your Goals | Weight Change (kg) | -1.52 kilograms | Standard Deviation 3.06 |
| Arm 2: Receiving Enhanced Usual Care | Weight Change (kg) | 0.23 kilograms | Standard Deviation 3.64 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Weight Change (kg)
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.
Time frame: 12 months
Population: Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputations to adjust for missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Receiving MOVE! Toward Your Goals | Weight Change (kg) | -1.02 kilograms | Standard Deviation 4.16 |
| Arm 2: Receiving Enhanced Usual Care | Weight Change (kg) | 0.74 kilograms | Standard Deviation 4.9 |
p-value: <0.05Wilcoxon (Mann-Whitney)