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CompletedNCT03260140D-ELITEUpdated Jul 28, 2023Results posted

DVD Lifestyle Intervention

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

Phase
Not applicable
Study type
Interventional
Enrollment
511
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

Keywords

  • weight loss
  • lifestyle
  • diet
  • exercise
  • randomized controlled trial
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
511 participants (actual)

Study arms

  • Experimental
    behavioral lifestyle intervention

    The investigators will provide participants with the the behavioral lifestyle intervention

    Behavioral: behavioral lifestyle intervention

  • No intervention
    usual care control

    participant in this arm will continue with usual care

Interventions

  • Behavioralbehavioral lifestyle intervention

    The investigators will provide participants with the behavioral lifestyle intervention

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. "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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

06

Results

Posted Nov 7, 2022

Participant flow

Participant flow — Overall Study
MilestoneBehavioral Lifestyle InterventionUsual Care Control
Started254257
Completed249252
Not completed55
Withdrew: Death41
Withdrew: Withdrawal by subject14

Outcome measures

PrimaryBody 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
Reported as:
Mean · kilogram (kg)
Body Weight
kilogram (kg)Behavioral Lifestyle InterventionUsual Care Control
Body Weight99.8 ± 15.8101.0 ± 15.0
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · Mixed Models Analysis · p = 0.001 · Mean difference (final values): -1.93 · 97.5% CI -3.24 to -0.61Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.
PrimaryShort 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
Reported as:
Mean · score on a scale
Short Form (SF)-12 PCS
score on a scaleBehavioral Lifestyle InterventionUsual Care Control
Short Form (SF)-12 PCS44.3 ± 10.743.2 ± 9.8
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · Mixed Models Analysis · p = 0.388 · Mean difference (final values): 0.69 · 97.5% CI -1.11 to 2.49Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.
SecondaryInternational 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
Reported as:
Count of participants · Participants
International Physical Activity Questionnaire (IPAQ)
ParticipantsBehavioral Lifestyle InterventionUsual Care Control
International Physical Activity Questionnaire (IPAQ)149143
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · F test-ratio of 2 McNemar's Chi-Squares · p = 0.308 · Sign test: 1.76 · 95% CI 0.85 to 3.66
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
Reported as:
Mean · score on a scale
"Starting the Conversation"
score on a scaleBehavioral Lifestyle InterventionUsual Care Control
"Starting the Conversation"6.2 ± 2.66.4 ± 2.7
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · Mixed Models Analysis · p = 0.396 · Mean difference (final values): -0.18 · 95% CI -0.61 to 0.24Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.
SecondaryPatient-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
Reported as:
Mean · T-score
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change
T-scoreBehavioral Lifestyle InterventionUsual Care Control
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change52.5 ± 9.252.0 ± 9.3
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · Mixed Models Analysis · p = 0.657 · Mean difference (final values): 0.30 · 95% CI -1.02 to 1.61Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.
SecondaryPatient-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
Reported as:
Mean · T-score
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change
T-scoreBehavioral Lifestyle InterventionUsual Care Control
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change51.7 ± 10.752.2 ± 10.3
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · Mixed Models Analysis · p = 0.281 · Mean difference (final values): -0.83 · 95% CI -2.33 to 0.68Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.
SecondaryDietary 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
Reported as:
Mean · score on a scale
Dietary Self-efficacy
score on a scaleBehavioral Lifestyle InterventionUsual Care Control
Dietary Self-efficacy3.1 ± 1.03.0 ± 1.0
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · Mixed Models Analysis · p = 0.483 · Mean difference (final values): 0.06 · 95% CI -0.11 to 0.23Standard errors estimated using Kenward-Rodgers adjustment for the denominator degrees of freedom.
SecondaryHemoglobin 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
Reported as:
Mean · percentage of glycosylated hemoglobin
Hemoglobin A1c (HbA1c)
percentage of glycosylated hemoglobinBehavioral Lifestyle InterventionUsual Care Control
Hemoglobin A1c (HbA1c)6.3 ± 1.56.4 ± 1.3
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · Mixed Models Analysis · p = 0.985 · Mean percent change in hba1c: 0.02 · 95% CI -2.57 to 2.69Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.
SecondaryShort 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
Reported as:
Mean · score on a scale
Short Form (SF)-12 Mental Component Score (MCS)
score on a scaleBehavioral Lifestyle InterventionUsual Care Control
Short Form (SF)-12 Mental Component Score (MCS)47.2 ± 12.448.1 ± 11.4
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · Mixed Models Analysis · p = 0.806 · Mean difference (net): -0.22 · 95% CI -1.99 to 1.55Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.
SecondaryDiastolic 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
Reported as:
Mean · millimeters of mercury (mmHg)
Diastolic Blood Pressure (DBP)
millimeters of mercury (mmHg)Behavioral Lifestyle InterventionUsual Care Control
Diastolic Blood Pressure (DBP)77.4 ± 8.077.2 ± 7.2
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · Mixed Models Analysis · p = 0.620 · Mean difference (final values): -0.36 · 95% CI -1.77 to 1.05Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.
SecondarySystolic 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
Reported as:
Mean · millimeters of mercury (mmHg)
Systolic Blood Pressure (SBP)
millimeters of mercury (mmHg)Behavioral Lifestyle InterventionUsual Care Control
Systolic Blood Pressure (SBP)127.3 ± 11.6126.9 ± 13.3
Statistical analysis
  • Behavioral Lifestyle Intervention vs Usual Care Control · Mixed Models Analysis · p = 0.987 · Mean difference (final values): -0.02 · 95% CI -2.32 to 2.28Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Behavioral Lifestyle Intervention4/254 (1.6%)47/254 (18.5%)124/254 (48.8%)
Usual Care Control1/257 (0.4%)42/257 (16.3%)105/257 (40.9%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventBehavioral Lifestyle InterventionUsual Care Control
CardiovascularCardiac disorders12/25418/257
OtherGeneral disorders11/2548/257
GastrointestinalGastrointestinal disorders10/2545/257
MusculoskeletalMusculoskeletal and connective tissue disorders10/2544/257
Pulmonary/RespiratoryRespiratory, thoracic and mediastinal disorders9/2545/257
Renal/UrologicRenal and urinary disorders5/2543/257
NeurologicalNervous system disorders4/2544/257
DermatologicalSkin and subcutaneous tissue disorders3/2544/257
HematologicalBlood and lymphatic system disorders3/2543/257
MetabolicMetabolism and nutrition disorders3/2542/257
Most frequent other events
Showing 10 of 12
Most frequent other events
EventBehavioral Lifestyle InterventionUsual Care Control
MusculoskeletalMusculoskeletal and connective tissue disorders65/25438/257
OtherGeneral disorders29/25422/257
GastrointestinalGastrointestinal disorders21/25416/257
DermatologicalSkin and subcutaneous tissue disorders19/25412/257
NeurologicalNervous system disorders18/25411/257
Pulmonary/RespiratoryRespiratory, thoracic and mediastinal disorders17/25416/257
CardiovascularCardiac disorders7/25414/257
Renal/UrologicRenal and urinary disorders11/2549/257
PsychologicalPsychiatric disorders5/2546/257
MetabolicMetabolism and nutrition disorders1/2545/257

Baseline characteristics

Age, Continuous
Age, Continuous(years)Behavioral Lifestyle InterventionUsual Care ControlTotal
Mean56.8 ± 14.1758.1 ± 13.5857.4 ± 13.88
Sex: Female, Male
Sex: Female, Male(Participants)Behavioral Lifestyle InterventionUsual Care ControlTotal
Female118112230
Male136145281
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Behavioral Lifestyle InterventionUsual Care ControlTotal
Hispanic or Latino372966
Not Hispanic or Latino217223440
Unknown or Not Reported055
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Behavioral Lifestyle InterventionUsual Care ControlTotal
American Indian or Alaska Native257
Asian617
Native Hawaiian or Other Pacific Islander033
Black or African American243256
White203206409
More than one race314
Unknown or Not Reported16925
07

Study locations

1 site
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA
    Seattle, Washington 98108-1532, United States
08

References and documents

Publications

  • 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. PubMed 32473403 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 8, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03260140
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Feb 15, 2018
Primary completion
Apr 1, 2021
Completion
Jun 30, 2021
Results posted
Nov 7, 2022
Last update
Jul 28, 2023

Study contacts

Katherine D Hoerster, PhD MPH BA
principal investigator · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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