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ObesityD-ELITENCT03260140

DVD Lifestyle Intervention

A study testing behavioral lifestyle intervention in people with Obesity, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
behavioral lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
511 participants
Where
1 siteUnited States
Study dates
15 Feb 2018to 30 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532

Other trials in United States

About this study

Official title: DVD Lifestyle Intervention (D-ELITE)

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.

Conditions
Obesity
Being tested
behavioral lifestyle intervention
Keywords
weight loss, lifestyle, diet, exercise, randomized controlled trial
Medical subject headings
Obesity, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • behavioral lifestyle interventionBehavioural

    The investigators will provide participants with the behavioral lifestyle intervention

Study groups in NCT03260140
Study groupRoleWhat they receive
behavioral lifestyle interventionExperimentalThe investigators will provide participants with the the behavioral lifestyle intervention
Receives: Behavioral: behavioral lifestyle intervention
usual care controlNo interventionparticipant in this arm will continue with usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 12 months post baseline

Secondary outcomes (9)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: SBP closest to 12 months from baseline between 9-15 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2017
  2. Study start15 Feb 2018
  3. Primary completion1 Apr 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The investigators will randomly assign participants to one of two groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03260140
Sponsor's protocol ID
IIR 15-364
Other IDs
I01HX002113
Acronym
D-ELITE
Status last verified
Jul 2023
First submitted
18 Aug 2017
Last updated
28 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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
  • 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.

    PubMed 36511927

Questions about this trial

What is this clinical trial studying?

A study testing behavioral lifestyle intervention in people with Obesity, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight (time frame: Weight closest to 12 months from baseline between 9-15 months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03260140, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.

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