Obesity
Conditions
Keywords
weight loss, lifestyle, diet, exercise, randomized controlled trial
Brief summary
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.
Interventions
BEHAVIORALbehavioral lifestyle intervention
The investigators will provide participants with the behavioral lifestyle intervention
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The investigators will randomly assign participants to one of two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recent VA primary care measured BMI between 30.0-44.9 kg/m2 (at facility in pacific or mountain time zone) * Access to DVD player or internet * Able to participate fully in all study protocol/procedures including informed consent
Exclusion criteria
* Inability to speak, read, or understand English * Recent weight loss interventions including use of prescription weight-loss medications, participation in group or individual weight loss programs provided by trained personnel, bariatric surgery (or plans for during the study period) * Expected weight loss because of alternate explanations such as from illness * High variability in weight due to fluctuations in volume status (ascites - liver disease, chronic heart failure) * Safety and/or adherence concerns due to severe physical or mental health issues, or life expectancy \<24 months * Pregnant, lactating, or planning to become pregnant during the study period; * Participation in other intervention studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | Weight closest to 12 months from baseline between 9-15 months post-baseline | 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. |
| Short Form (SF)-12 PCS | 12 months post baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change | 12 months post baseline | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change | 12 months post baseline | 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. |
| Dietary Self-efficacy | 12 months post baseline | 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. |
| International Physical Activity Questionnaire (IPAQ) | 12 months post baseline | 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. |
| Short Form (SF)-12 Mental Component Score (MCS) | 12 months post baseline | 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. |
| Diastolic Blood Pressure (DBP) | DBP closest to 12 months from baseline between 9-15 months post-baseline | DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats. |
| Systolic Blood Pressure (SBP) | SBP closest to 12 months from baseline between 9-15 months post-baseline | 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. |
| Hemoglobin A1c (HbA1c) | HbA1c closest to 12 months from baseline between 9-15 months post-baseline | HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood. |
| Starting the Conversation | 12 months post baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 254 |
| Usual Care Control participant in this arm will continue with usual care | 257 |
| Total | 511 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Usual Care Control | Total | Behavioral Lifestyle Intervention |
|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 13.58 | 57.4 years STANDARD_DEVIATION 13.88 | 56.8 years STANDARD_DEVIATION 14.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 66 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 223 Participants | 440 Participants | 217 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 56 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 25 Participants | 16 Participants |
| Race (NIH/OMB) White | 206 Participants | 409 Participants | 203 Participants |
| Sex: Female, Male Female | 112 Participants | 230 Participants | 118 Participants |
| Sex: Female, Male Male | 145 Participants | 281 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 254 | 1 / 257 |
| other Total, other adverse events | 124 / 254 | 105 / 257 |
| serious Total, serious adverse events | 47 / 254 | 42 / 257 |
Outcome results
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.
Time frame: Weight closest to 12 months from baseline between 9-15 months post-baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Body Weight | 99.8 kilogram (kg) | Standard Deviation 15.8 |
| Usual Care Control | Body Weight | 101.0 kilogram (kg) | Standard Deviation 15 |
Comparison: Linear mixed model analysis comparing the average 12-month weight between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.p-value: 0.00197.5% CI: [-3.24, -0.61]Mixed Models Analysis
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.
Time frame: 12 months post baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Short Form (SF)-12 PCS | 44.3 score on a scale | Standard Deviation 10.7 |
| Usual Care Control | Short Form (SF)-12 PCS | 43.2 score on a scale | Standard Deviation 9.8 |
Comparison: Linear mixed model analysis comparing the 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.p-value: 0.38897.5% CI: [-1.11, 2.49]Mixed Models Analysis
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.
Time frame: DBP closest to 12 months from baseline between 9-15 months post-baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Diastolic Blood Pressure (DBP) | 77.4 millimeters of mercury (mmHg) | Standard Deviation 8 |
| Usual Care Control | Diastolic Blood Pressure (DBP) | 77.2 millimeters of mercury (mmHg) | Standard Deviation 7.2 |
Comparison: Linear mixed model analysis comparing the average 12-month DBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.p-value: 0.6295% CI: [-1.77, 1.05]Mixed Models Analysis
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.
Time frame: 12 months post baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Dietary Self-efficacy | 3.1 score on a scale | Standard Deviation 1 |
| Usual Care Control | Dietary Self-efficacy | 3.0 score on a scale | Standard Deviation 1 |
Comparison: Linear mixed model analysis comparing the average score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.p-value: 0.48395% CI: [-0.11, 0.23]Mixed Models Analysis
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.
Time frame: HbA1c closest to 12 months from baseline between 9-15 months post-baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Hemoglobin A1c (HbA1c) | 6.3 percentage of glycosylated hemoglobin | Standard Deviation 1.5 |
| Usual Care Control | Hemoglobin A1c (HbA1c) | 6.4 percentage of glycosylated hemoglobin | Standard Deviation 1.3 |
Comparison: Linear mixed model analysis on log-transformed HbA1c comparing the average HbA1c between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.p-value: 0.98595% CI: [-2.57, 2.69]Mixed Models Analysis
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.
Time frame: 12 months post baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Lifestyle Intervention | International Physical Activity Questionnaire (IPAQ) | 149 Participants |
| Usual Care Control | International Physical Activity Questionnaire (IPAQ) | 143 Participants |
Comparison: Group-specific McNemar's Chi-Square tests were applied to examine the change from baseline to follow-up in dichotomized IPAQ (\>=150 vs \<150) minutes of physical activity per week. To compare intervention vs. control at 12 months, we applied an F test. The intervention effect was an odds ratio of the ratios of discordant pairs in the intervention vs the control group.p-value: 0.30895% CI: [0.85, 3.66]F test-ratio of 2 McNemar's Chi-Squares
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.
Time frame: 12 months post baseline
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change | 52.5 T-score | Standard Deviation 9.2 |
| Usual Care Control | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change | 52.0 T-score | Standard Deviation 9.3 |
Comparison: Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.p-value: 0.65795% CI: [-1.02, 1.61]Mixed Models Analysis
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.
Time frame: 12 months post baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change | 51.7 T-score | Standard Deviation 10.7 |
| Usual Care Control | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change | 52.2 T-score | Standard Deviation 10.3 |
Comparison: Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.p-value: 0.28195% CI: [-2.33, 0.68]Mixed Models Analysis
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.
Time frame: 12 months post baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Short Form (SF)-12 Mental Component Score (MCS) | 47.2 score on a scale | Standard Deviation 12.4 |
| Usual Care Control | Short Form (SF)-12 Mental Component Score (MCS) | 48.1 score on a scale | Standard Deviation 11.4 |
Comparison: Linear mixed model analysis comparing the average 12-month MCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.p-value: 0.80695% CI: [-1.99, 1.55]Mixed Models Analysis
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.
Time frame: 12 months post baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Starting the Conversation | 6.2 score on a scale | Standard Deviation 2.6 |
| Usual Care Control | Starting the Conversation | 6.4 score on a scale | Standard Deviation 2.7 |
Comparison: Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.p-value: 0.39695% CI: [-0.61, 0.24]Mixed Models Analysis
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.
Time frame: SBP closest to 12 months from baseline between 9-15 months post-baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Lifestyle Intervention | Systolic Blood Pressure (SBP) | 127.3 millimeters of mercury (mmHg) | Standard Deviation 11.6 |
| Usual Care Control | Systolic Blood Pressure (SBP) | 126.9 millimeters of mercury (mmHg) | Standard Deviation 13.3 |
Comparison: Linear mixed model analysis comparing the average SBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.p-value: 0.98795% CI: [-2.32, 2.28]Mixed Models Analysis