An interventional study of behavioral lifestyle intervention in Obesity, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-28.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Among 54 studies in Obesity by VA Office of Research and Development — 9 open to participants now, 13 under way, none of them phase 3. Obesity · VA Office of Research and Development.
Among the 54 studies in Obesity by VA Office of Research and Development, this one is the 6th largest by enrollment of the 52 interventional ones that give a count, is one of 5 that started in 2018, is one of 47 with no phase, and was the 28th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →9 of the 54 studies in Obesity by VA Office of Research and Development are open now, in 1 country. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
VA Office of Research and Development · Sites in United States
VA Office of Research and Development · Sites in United States
VA Office of Research and Development · Sites in United States
VA Office of Research and Development · Sites in United States
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
54 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 5 started in 2018.
This study's enrollment of 511 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 122 across the 52 interventional studies, 69 across the 2 observational. Of the 39 that completed or were terminated, 34 (87%) have results posted.
This tab as a report to print or save as PDF → With an account.
VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
2 of the studies in Obesity by VA Office of Research and Development that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05225233VA Office of Research and DevelopmenttDCS With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity | 2026-12-31 |
| NCT06619041VA Office of Research and DevelopmentHealthyTogether: RCT of a Dyadic Weight Management Intervention | 2027-09-30 |
Among the 54 studies in Obesity by VA Office of Research and Development, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The investigators will provide participants with the the behavioral lifestyle intervention
Behavioral: behavioral lifestyle intervention
participant in this arm will continue with usual care
The investigators will provide participants with the behavioral lifestyle intervention
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.
Time frame: 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.
Time frame: 12 months post baseline
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.
Time frame: 12 months post baseline
"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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: SBP closest to 12 months from baseline between 9-15 months post-baseline
| Milestone | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| Started | 254 | 257 |
| Completed | 249 | 252 |
| Not completed | 5 | 5 |
| Withdrew: Death | 4 | 1 |
| Withdrew: Withdrawal by subject | 1 | 4 |
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.
| kilogram (kg) | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| Body Weight | 99.8 ± 15.8 | 101.0 ± 15.0 |
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.
| score on a scale | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| Short Form (SF)-12 PCS | 44.3 ± 10.7 | 43.2 ± 9.8 |
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.
| Participants | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| International Physical Activity Questionnaire (IPAQ) | 149 | 143 |
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.
| score on a scale | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| "Starting the Conversation" | 6.2 ± 2.6 | 6.4 ± 2.7 |
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.
| T-score | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change | 52.5 ± 9.2 | 52.0 ± 9.3 |
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.
| T-score | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change | 51.7 ± 10.7 | 52.2 ± 10.3 |
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.
| score on a scale | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| Dietary Self-efficacy | 3.1 ± 1.0 | 3.0 ± 1.0 |
HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood.
| percentage of glycosylated hemoglobin | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| Hemoglobin A1c (HbA1c) | 6.3 ± 1.5 | 6.4 ± 1.3 |
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.
| score on a scale | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| Short Form (SF)-12 Mental Component Score (MCS) | 47.2 ± 12.4 | 48.1 ± 11.4 |
DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats.
| millimeters of mercury (mmHg) | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| Diastolic Blood Pressure (DBP) | 77.4 ± 8.0 | 77.2 ± 7.2 |
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.
| millimeters of mercury (mmHg) | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| Systolic Blood Pressure (SBP) | 127.3 ± 11.6 | 126.9 ± 13.3 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral Lifestyle Intervention | 4/254 (1.6%) | 47/254 (18.5%) | 124/254 (48.8%) |
| Usual Care Control | 1/257 (0.4%) | 42/257 (16.3%) | 105/257 (40.9%) |
| Event | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| CardiovascularCardiac disorders | 12/254 | 18/257 |
| OtherGeneral disorders | 11/254 | 8/257 |
| GastrointestinalGastrointestinal disorders | 10/254 | 5/257 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 10/254 | 4/257 |
| Pulmonary/RespiratoryRespiratory, thoracic and mediastinal disorders | 9/254 | 5/257 |
| Renal/UrologicRenal and urinary disorders | 5/254 | 3/257 |
| NeurologicalNervous system disorders | 4/254 | 4/257 |
| DermatologicalSkin and subcutaneous tissue disorders | 3/254 | 4/257 |
| HematologicalBlood and lymphatic system disorders | 3/254 | 3/257 |
| MetabolicMetabolism and nutrition disorders | 3/254 | 2/257 |
| Event | Behavioral Lifestyle Intervention | Usual Care Control |
|---|---|---|
| MusculoskeletalMusculoskeletal and connective tissue disorders | 65/254 | 38/257 |
| OtherGeneral disorders | 29/254 | 22/257 |
| GastrointestinalGastrointestinal disorders | 21/254 | 16/257 |
| DermatologicalSkin and subcutaneous tissue disorders | 19/254 | 12/257 |
| NeurologicalNervous system disorders | 18/254 | 11/257 |
| Pulmonary/RespiratoryRespiratory, thoracic and mediastinal disorders | 17/254 | 16/257 |
| CardiovascularCardiac disorders | 7/254 | 14/257 |
| Renal/UrologicRenal and urinary disorders | 11/254 | 9/257 |
| PsychologicalPsychiatric disorders | 5/254 | 6/257 |
| MetabolicMetabolism and nutrition disorders | 1/254 | 5/257 |
| Age, Continuous(years) | Behavioral Lifestyle Intervention | Usual Care Control | Total |
|---|---|---|---|
| Mean | 56.8 ± 14.17 | 58.1 ± 13.58 | 57.4 ± 13.88 |
| Sex: Female, Male(Participants) | Behavioral Lifestyle Intervention | Usual Care Control | Total |
|---|---|---|---|
| Female | 118 | 112 | 230 |
| Male | 136 | 145 | 281 |
| Ethnicity (NIH/OMB)(Participants) | Behavioral Lifestyle Intervention | Usual Care Control | Total |
|---|---|---|---|
| Hispanic or Latino | 37 | 29 | 66 |
| Not Hispanic or Latino | 217 | 223 | 440 |
| Unknown or Not Reported | 0 | 5 | 5 |
| Race (NIH/OMB)(Participants) | Behavioral Lifestyle Intervention | Usual Care Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 5 | 7 |
| Asian | 6 | 1 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 3 | 3 |
| Black or African American | 24 | 32 | 56 |
| White | 203 | 206 | 409 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 16 | 9 | 25 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Apr 2021, 37 months.
Results were first posted in Nov 2022, 1 year 7 months after primary completion.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 37 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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