Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I01HX002113 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Most Veterans who receive VA healthcare have obesity (41%) or are classified as overweight (37%), putting them at higher risk for multiple serious chronic health conditions. Providing evidence-based behavioral weight management programs to Veterans with obesity is a priority for the VA National Center for Health Promotion and Disease Prevention (NCP). While the VA NCP's MOVE! program-primarily delivered with in-person group visits-helps Veterans with obesity lose weight, its reach has been limited because of various barriers to care. Some Veterans may do better with a program they can complete from home at their own pace. In this trial, study investigators are examining the effectiveness among Veterans of a previously proven self-directed lifestyle intervention (called DVD Lifestyle Intervention (D-ELITE)) that targets modest, clinically meaningful weight loss over the course of a year using recorded video lessons (DVD or online streaming), written self-study aids, and optional lifestyle coaching. The study will compare participants randomly assigned to receive D-ELITE to those continuing in usual care on weight and self-reported general physical health status, one year after enrollment. Secondary outcomes include weight and general physical health status two years after enrollment; and obesity-related biometric measures (blood pressure and HbA1c) and self-report psychological and behavioral factors such as physical activity and sleep quality, at one- and two-years following enrollment.
Veterans with obesity living in the western US were identified using the VA Corporate Data Warehouse (CDW), recruited to participate via mail and telephone, and randomly assigned to receive the study intervention or usual care alone. The study uses CDW to assess weight change and biometric outcomes. To assess self-report outcomes, participants completed questionnaires, by mail or telephone, at baseline and 12 months after randomization, and are currently completing 24-month follow-up questionnaires. The D-ELITE intervention focuses on gradual lifestyle behavior change aimed at improving eating habits and increasing physical activity. It encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The D-ELITE intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants have access to a lifestyle coach, as desired, for the full 12-month intervention period. In addition to patient outcomes, this study will examine the cost of delivering the intervention, information relevant to decision-makers and potential future dissemination. Evidence-based programs like this, which can be delivered remotely and with likely minimal resources required from the VA healthcare system, are greatly needed, especially now as the SARS-CoV-2 pandemic has required VA to rapidly transition to providing more remotely-delivered care.
Impact: The DELITE trial has potential to provide the evidence needed for deciding whether a low-cost, low-technology, self-directed program can be used to expand the treatment of obesity to a population-based level by improving access to obesity treatment regardless of Veteran place of residence.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| behavioral lifestyle intervention | Experimental | The investigators will provide participants with the the behavioral lifestyle intervention |
|
| usual care control | No Intervention | participant in this arm will continue with usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral lifestyle intervention | Behavioral | The investigators will provide participants with the behavioral lifestyle intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Weights were obtained from the VA electronic health record. For the weight variable, baseline is the weight used to identify Veterans for recruitment to participate. | Weight closest to 12 months from baseline between 9-15 months post-baseline |
| Short Form (SF)-12 PCS | The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the PCS score serving as co-primary outcome. The investigators scored the SF-12 using QualityMetric's scoring software. PCS scores range from 0-100 with higher scores indicating better general physical health. | 12 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| International Physical Activity Questionnaire (IPAQ) | 7-item short form of the IPAQ, which evaluates weekly walking, vigorous and moderate-intensity activity. The investigators report here the number of participants engaging in at least 150 minutes of activity per week. | 12 months post baseline |
| "Starting the Conversation" |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katherine D Hoerster, PhD MPH BA | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108-1532 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32473403 | Result | Hoerster KD, Collins MP, Au DH, Lane A, Epler E, McDowell J, Baron AE, Rise P, Plumley R, Nguyen T, Schooler M, Schuttner L, Ma J. Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial. Contemp Clin Trials. 2020 Aug;95:106045. doi: 10.1016/j.cct.2020.106045. Epub 2020 May 28. | |
| 36511927 | Derived | Hoerster KD, Hunter-Merrill R, Nguyen T, Rise P, Baron AE, McDowell J, Donovan LM, Gleason E, Lane A, Plumley R, Schooler M, Schuttner L, Collins M, Au DH, Ma J. Effect of a Remotely Delivered Self-directed Behavioral Intervention on Body Weight and Physical Health Status Among Adults With Obesity: The D-ELITE Randomized Clinical Trial. JAMA. 2022 Dec 13;328(22):2230-2241. doi: 10.1001/jama.2022.21177. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Lifestyle Intervention | behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention |
| FG001 | Usual Care Control | participant in this arm will continue with usual care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Lifestyle Intervention | The investigators will provide participants with the the behavioral lifestyle intervention behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention |
| BG001 | Usual Care Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Weight | Weights were obtained from the VA electronic health record. For the weight variable, baseline is the weight used to identify Veterans for recruitment to participate. | The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | kilogram (kg) | Weight closest to 12 months from baseline between 9-15 months post-baseline |
|
We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Lifestyle Intervention | The investigators will provide participants with the the behavioral lifestyle intervention behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret P. Collins | VA Puget Sound Health Care Sysem | 206.764.2085 | margaret.collins@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2021 | Jan 11, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
The investigators will randomly assign participants to one of two groups.
Not provided
Not provided
Not provided
8-item self-report measure of diet quality that assesses intake of various types of food (e.g., fruit and vegetable, sugary beverages). Scores range from 0-16 with higher scores indicating better diet quality. |
| 12 months post baseline |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change | 4-item self-report scale indicating sleep disturbance. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep disturbance. | 12 months post baseline |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change | 8-item self-report scale indicating sleep impairment. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep impairment. | 12 months post baseline |
| Dietary Self-efficacy | Three items measuring diet self-efficacy from the Patient-centered Assessment and Counseling for Exercise plus Nutrition (PACE+) Adult Psychosocial Questionnaire. Scores range from 1-5 with higher scores representing higher diet self-efficacy. | 12 months post baseline |
| Hemoglobin A1c (HbA1c) | HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood. | HbA1c closest to 12 months from baseline between 9-15 months post-baseline |
| Short Form (SF)-12 Mental Component Score (MCS) | The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the MCS score assessing mental health status. The investigators scored the SF-12 using QualityMetric's scoring software. MCS scores range from 0-100 with higher scores indicating better general menal health. | 12 months post baseline |
| Diastolic Blood Pressure (DBP) | DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats. | DBP closest to 12 months from baseline between 9-15 months post-baseline |
| Systolic Blood Pressure (SBP) | SBP values were obtained from the VA electronic health record. SBP is a measure of how much pressure blood is exerting against artery walls when the heart beats. | SBP closest to 12 months from baseline between 9-15 months post-baseline |
participant in this arm will continue with usual care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Usual Care Control |
participant in this arm will continue with usual care |
|
|
|
| Primary | Short Form (SF)-12 PCS | The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the PCS score serving as co-primary outcome. The investigators scored the SF-12 using QualityMetric's scoring software. PCS scores range from 0-100 with higher scores indicating better general physical health. | The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | score on a scale | 12 months post baseline |
|
|
|
|
| Secondary | International Physical Activity Questionnaire (IPAQ) | 7-item short form of the IPAQ, which evaluates weekly walking, vigorous and moderate-intensity activity. The investigators report here the number of participants engaging in at least 150 minutes of activity per week. | The investigators report here the unadjusted number of participants engaging in at least 150 minutes of activity per week. The analysis population for adjusted between-group differences includes study participants with measurements at both baseline and 12 months; see Statistical Analysis 1 for those results. | Posted | Count of Participants | Participants | 12 months post baseline |
|
|
|
|
| Secondary | "Starting the Conversation" | 8-item self-report measure of diet quality that assesses intake of various types of food (e.g., fruit and vegetable, sugary beverages). Scores range from 0-16 with higher scores indicating better diet quality. | The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | score on a scale | 12 months post baseline |
|
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change | 4-item self-report scale indicating sleep disturbance. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep disturbance. | The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results | Posted | Mean | Standard Deviation | T-score | 12 months post baseline |
|
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change | 8-item self-report scale indicating sleep impairment. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep impairment. | The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | T-score | 12 months post baseline |
|
|
|
|
| Secondary | Dietary Self-efficacy | Three items measuring diet self-efficacy from the Patient-centered Assessment and Counseling for Exercise plus Nutrition (PACE+) Adult Psychosocial Questionnaire. Scores range from 1-5 with higher scores representing higher diet self-efficacy. | The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | score on a scale | 12 months post baseline |
|
|
|
|
| Secondary | Hemoglobin A1c (HbA1c) | HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood. | The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | HbA1c closest to 12 months from baseline between 9-15 months post-baseline |
|
|
|
|
| Secondary | Short Form (SF)-12 Mental Component Score (MCS) | The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the MCS score assessing mental health status. The investigators scored the SF-12 using QualityMetric's scoring software. MCS scores range from 0-100 with higher scores indicating better general menal health. | The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | score on a scale | 12 months post baseline |
|
|
|
|
| Secondary | Diastolic Blood Pressure (DBP) | DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats. | The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | DBP closest to 12 months from baseline between 9-15 months post-baseline |
|
|
|
|
| Secondary | Systolic Blood Pressure (SBP) | SBP values were obtained from the VA electronic health record. SBP is a measure of how much pressure blood is exerting against artery walls when the heart beats. | The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | SBP closest to 12 months from baseline between 9-15 months post-baseline |
|
|
|
|
| 4 |
| 254 |
| 47 |
| 254 |
| 124 |
| 254 |
| EG001 | Usual Care Control | participant in this arm will continue with usual care | 1 | 257 | 42 | 257 | 105 | 257 |
| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
|
| Metabolic | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neurological | Nervous system disorders | Systematic Assessment |
|
| Psychological | Psychiatric disorders | Systematic Assessment |
|
| Pulmonary/Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Renal/Urologic | Renal and urinary disorders | Systematic Assessment |
|
| Hepatobiliary | Hepatobiliary disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
|
| Metabolic | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neurological | Nervous system disorders | Systematic Assessment |
|
| Psychological | Psychiatric disorders | Systematic Assessment |
|
| Pulmonary/Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Renal/Urologic | Renal and urinary disorders | Systematic Assessment |
|
| Hepatobiliary | Hepatobiliary disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |