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Improving Weight Management at the VA

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02626819
Collaborator
(none)
45
Enrollment
2
Locations
2
Arms
31
Actual Duration (Months)
22.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MOVE! Toward Your Goals
  • Behavioral: Enhanced Usual Care
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Blinded to intervention arm
Primary Purpose:
Health Services Research
Official Title:
Improving Weight Management at VA: Enhancing the MOVE!23 for Primary Care (CDA 10-206)
Actual Study Start Date :
Aug 3, 2015
Actual Primary Completion Date :
May 31, 2017
Actual Study Completion Date :
Mar 5, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Behavioral: 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
Other Names:
  • MTG arm

    		•
    Active Comparator: 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)

    Behavioral: 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.
    Other Names:
  • EUC arm

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Weight Change (kg) [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.

    3. Weight Change (kg) [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.

    4. 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.

    5. 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.

    6. Percent of Patients With Clinically Significant Weight Loss [6 months]

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

    7. 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.

    8. Percent of Patients With Clinically Significant Weight Loss [12 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY Brooklyn New York United States 11209
    2 Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY New York New York United States 10010

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Melanie R. Jay, MD MS, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT02626819
    Other Study ID Numbers:
    • CDP 12-252
    • CDA 10-206
    First Posted:
    Dec 10, 2015
    Last Update Posted:
    Dec 21, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development
    Obesity
    Weight Management
    Primary Care
    Health Coach
    iPad
    Goal Setting
    5As
    technology
    Additional relevant MeSH terms:
    Obesity

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Arm/Group Description 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 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.
    Period Title: Overall Study
    STARTED 22 23
    COMPLETED 18 20
    NOT COMPLETED 4 3

    Baseline Characteristics

    Arm/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care Total
    Arm/Group Description 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 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. Total of all reporting groups
    Overall Participants 22 23 45
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    18
    81.8%
    19
    82.6%
    37
    82.2%
    >=65 years
    3
    13.6%
    3
    13%
    6
    13.3%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    53.29
    (10.37)
    56.14
    (10.73)
    54.74
    (10.53)
    Sex: Female, Male (Count of Participants)
    Female
    5
    22.7%
    9
    39.1%
    14
    31.1%
    Male
    16
    72.7%
    13
    56.5%
    29
    64.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    3
    13.6%
    6
    26.1%
    9
    20%
    Not Hispanic or Latino
    18
    81.8%
    15
    65.2%
    33
    73.3%
    Unknown or Not Reported
    0
    0%
    1
    4.3%
    1
    2.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    4.5%
    0
    0%
    1
    2.2%
    Asian
    2
    9.1%
    0
    0%
    2
    4.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    11
    50%
    11
    47.8%
    22
    48.9%
    White
    4
    18.2%
    4
    17.4%
    8
    17.8%
    More than one race
    3
    13.6%
    6
    26.1%
    9
    20%
    Unknown or Not Reported
    0
    0%
    1
    4.3%
    1
    2.2%
    Body Mass Index (BMI) (kg/m2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m2]
    30.7
    (3.4)
    33.0
    (5.8)
    31.8
    (4.9)

    Outcome Measures

    1. Primary Outcome
    Title Weight Change (kg)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputations to adjust for missing data.
    Arm/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Arm/Group Description 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 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.
    Measure Participants 21 22
    Mean (Standard Deviation) [kilograms]
    -1.06
    (1.72)
    0.07
    (2.40)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Receiving MOVE! Toward Your Goals, Arm 2: Receiving Enhanced Usual Care
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data
    2. Primary Outcome
    Title Weight Change (kg)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data
    Arm/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Arm/Group Description 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 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.
    Measure Participants 21 22
    Mean (Standard Deviation) [kilograms]
    -1.52
    (3.06)
    0.23
    (3.64)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Receiving MOVE! Toward Your Goals, Arm 2: Receiving Enhanced Usual Care
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data.
    3. Primary Outcome
    Title Weight Change (kg)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputations to adjust for missing data
    Arm/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Arm/Group Description 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 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.
    Measure Participants 21 22
    Mean (Standard Deviation) [kilograms]
    -1.02
    (4.16)
    0.74
    (4.90)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Receiving MOVE! Toward Your Goals, Arm 2: Receiving Enhanced Usual Care
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data
    4. Primary Outcome
    Title Percent of Patients With Clinically Significant Weight Loss
    Description The percentage of patients who achieve 5-10% weight loss at 3- month study visit.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    At the 3-months, 6 participants in Arm 1 did not complete the study visits and thus were not included in analysis.
    Arm/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Arm/Group Description 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 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.
    Measure Participants 15 22
    Count of Participants [Participants]
    1
    4.5%
    2
    8.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Receiving MOVE! Toward Your Goals, Arm 2: Receiving Enhanced Usual Care
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Fisher Exact
    Comments
    5. Primary Outcome
    Title Percent of Patients With 2.5% Weight Loss at 6 Months.
    Description Percentage of patients who achieved 2.5% weight loss at 6 months. Weight measured in kg.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Arm/Group Description 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 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.
    Measure Participants 19 21
    Count of Participants [Participants]
    7
    31.8%
    5
    21.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Receiving MOVE! Toward Your Goals, Arm 2: Receiving Enhanced Usual Care
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Fisher Exact
    Comments
    6. Primary Outcome
    Title Percent of Patients With Clinically Significant Weight Loss
    Description The percentage of patients who achieve 5-10% weight loss at 6- month study visit.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Arm/Group Description 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 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.
    Measure Participants 19 21
    Count of Participants [Participants]
    2
    9.1%
    1
    4.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Receiving MOVE! Toward Your Goals, Arm 2: Receiving Enhanced Usual Care
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Fisher Exact
    Comments
    7. Primary Outcome
    Title Percent of Patients Who Achieved 2.5% Weight Loss
    Description Percentage of patients who achieved 2.5% weight loss at 12 months. Weight measured in kg.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Arm/Group Description 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 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.
    Measure Participants 18 20
    Count of Participants [Participants]
    5
    22.7%
    4
    17.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Receiving MOVE! Toward Your Goals, Arm 2: Receiving Enhanced Usual Care
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Fisher Exact
    Comments
    8. Primary Outcome
    Title Percent of Patients With Clinically Significant Weight Loss
    Description The percentage of patients who achieve 5-10% weight loss at 12- month study visit.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Arm/Group Description 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 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.
    Measure Participants 18 20
    Count of Participants [Participants]
    2
    9.1%
    3
    13%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Receiving MOVE! Toward Your Goals, Arm 2: Receiving Enhanced Usual Care
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Fisher Exact
    Comments

    Adverse Events

    Time Frame 1 year
    Adverse Event Reporting Description
    Arm/Group Title Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Arm/Group Description 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 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.
    All Cause Mortality
    Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/22 (0%) 0/23 (0%)
    Serious Adverse Events
    Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/22 (0%) 0/23 (0%)
    Other (Not Including Serious) Adverse Events
    Arm 1: Receiving MOVE! Toward Your Goals Arm 2: Receiving Enhanced Usual Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/22 (0%) 0/23 (0%)

    Limitations/Caveats

    Small sample size, thus unpowered to see significant results Low yield of recruitment Research Assistants not blinded to study arm

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Melanie Jay, MD MS
    Organization Manhattan Campus of the VA NY Harbor Healthcare System
    Phone 212-686-7500 ext 5097
    Email melanie.jay@va.gov
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT02626819
    Other Study ID Numbers:
    • CDP 12-252
    • CDA 10-206
    First Posted:
    Dec 10, 2015
    Last Update Posted:
    Dec 21, 2018
    Last Verified:
    Jun 1, 2018