ObesityTOTALNCT05346575
Teaching Obesity Treatment Options to Adult Learners (TOTAL): A Multisite RCT
A study testing Teaching Obesity Treatments to Adult Learners (TOTAL) in people with Obesity and Overweight, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Nearly 8 in 10 Veterans meet criteria for overweight/obesity. Three evidence-based treatment options are available within VA (behavioral weight management [MOVE!], obesity medications, and bariatric surgery). However, all treatments are significantly underutilized. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Teaching Obesity Treatments to Adult Learners (TOTAL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- No MOVE! visit attendance within the last 12 months
- No previous bariatric surgery
- Not currently on weight loss medications
- BMI of 30 kg/m2 or 27-29.9 + an obesity-related comorbidity
Who cannot join
- Pregnant or are planning to become pregnant within the study period
- Currently breast feeding
- Have cancer not in remission
- Do not have access to a telephone
- Have severe hearing/visual impairment
- Weigh more than 420 lbs (due to scale limitations)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
About this study
Official title: Teaching Obesity Treatment Options to Adult Learners (TOTAL): A Multi-site RCT
Nearly 8 in 10 Veterans meet criteria for overweight/obesity. Three evidence-based treatment options are available within VA (behavioral weight management [MOVE!], obesity medications, and bariatric surgery).
However, all treatments are significantly underutilized. This study will evaluate the effectiveness of a novel intervention designed to increase obesity treatment initiation and subsequently weight loss within VA. The intervention, Teaching Obesity Treatment Options to Adult Learners (TOTAL), involves an educational video and multiple motivational sessions delivered via telemedicine. If effective, TOTAL could be implemented throughout VA without requiring significant resources and could be integrated into the existing VA behavioral weight management program, MOVE!, which is present at nearly every VA medical center.
Read the detailed description
Background: Nearly 80% of Veterans meet criteria for overweight (body mass index [BMI] of 25-29.9 kg/m2) or obesity (BMI 30). VA offers three evidence-based obesity treatments at little to no cost to Veterans: MOVE! (to improve dietary intake and physical activity through behavioral modification); obesity medications; and bariatric surgery, but all are significantly underutilized: <10% of Veterans with obesity participate in MOVE!; 2% receive obesity medications; and 0.3% of those who meet BMI criteria for bariatric surgery (BMI 35) undergo it. There is an urgent need to increase use of all three treatments to improve Veteran health.
Significance/Impact: Nearly 4,000,000 Veterans meet BMI criteria for overweight/obesity. It is essential that Veterans with overweight/obesity are aware of the three treatment options and are motivated to pursue them. Currently, no interventions in VA seek to increase use of all three evidence-based obesity treatment options for Veterans not currently participating in MOVE!. The TOTAL intervention (Teaching Obesity Treatment Options to Adults Learners), if effective, would increase obesity treatment initiation for Veterans, lead to greater weight loss, and improve quality of life. Given that TOTAL is deliverable via VA telemedicine, it could be implemented throughout the VA healthcare system without requiring significant resources and could be integrated into the existing VA behavioral weight management program, MOVE!.
Innovation: The research in this proposal would be the first adequately powered RCT in VA testing an intervention to increase use of all three evidence-based obesity treatments: MOVE!, obesity medications, and bariatric surgery. It would leverage the power of the VA electronic health record and would improve access to care by expanding use of a recently developed telemedicine technology - VA Video Connect (VVC) - which was developed by VA researchers. It could be implemented and disseminated efficiently within VA given that MOVE! is available at every VAMC and is supported by NCP.
Specific Aims: Aim 1: Compare the effectiveness of TOTAL vs. usual care for increasing obesity treatment initiation among Veterans with overweight/obesity who are not participating in MOVE!; Aim 2: Compare the effectiveness of TOTAL vs. usual care for increasing sustained MOVE! participation, receipt of an obesity medication prescription or bariatric surgery referral, and weight loss; Aim 3: Inform future dissemination efforts of TOTAL via interviews with key stakeholders, a "Reach" analysis, and cost analysis.
Methodology: Study population: Veterans at two VAMCs, age 18-75 with a BMI 30 or 27-29.9 + an obesity related comorbidity who have not had a MOVE! visit within the past 12 months and thus are not participating in obesity treatment will participate in the RCT; Intervention: The TOTAL intervention consists of an 18-minute obesity treatment educational video and three motivational sessions (all delivered via VA Video Connect [VVC]); Comparison: Usual care (Veterans who have not had a MOVE! visit in the previous 12 months); Outcomes: MOVE! initiation, sustained MOVE! participation, obesity medication use, bariatric surgery referral, weight change; Timing: Primary and secondary outcomes will be measured 18 months post-randomization.
Implementation/Next Steps: Facilitators and barriers to TOTAL implementation will be assessed in Aim 3 interviews with Veteran, provider, and operations stakeholders using the Consolidated Framework for Implementation Research (CFIR). The investigators will also perform "reach" and cost analyses. The investigators will collaborate with NCP to disseminate TOTAL to all VAMCs that have a MOVE! program. The National MOVE! Director will present study results on a national MOVE! call and make presentation materials available on the national MOVE! SharePoint dissemination site. The National MOVE! Director will support MOVE! coordinators who work directly with health behavior coordinators at every VAMC with MOVE!. The study team will consider partnering with NCP to conduct a QUERI National Partnered Evaluation evaluating how TOTAL can be implemented throughout VA.
- Conditions
- Obesity, Overweight
- Being tested
- Teaching Obesity Treatments to Adult Learners (TOTAL), Usual care
- Keywords
- Bariatric Surgery, Weight-Loss Drugs, Diet, Therapy, Physical Activity, Body Mass Index, Veteran
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching Obesity Treatments to Adult Learners (TOTAL)Behavioural
TOTAL includes both video component and motivational telemedicine calls delivered via VA Video Connect (VVC) by a study interventionist. The investigators will invite study participants to watch the 18-minute video at least once. The motivational component of TOTAL will consist of three telemedicine-based (VVC), one-on-one, 30-minute calls at 1 week, 6 months, and 12 months after randomization. This timing was selected so Veterans would have regular interactions with the interventionist within one year of initiating the intervention. Each motivational session will be tailored to where Veterans are in the treatment initiation process. Electronic outcome assessment surveys will be sent to the participants at baseline, at each motivational telemedicine visit, and for the 18 month assessment.
Usual careBehavioural
The usual care group will be electronically sent the 1-week, 6-month, 12-month, 18-month assessments. All usual care participants will be offered the opportunity to watch the educational video component of TOTAL after the final outcome assessment is performed (18 months post-randomization). Veterans in the usual care arm will also have access to the MOVE! program via referrals from the PCP or self-referral to MOVE!. If they initiate treatment in MOVE!, they may progress through MOVE! and receive obesity medications or be referred for bariatric surgery if they choose to do so.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants randomized to this arm will receive the usual obesity care, but will complete assessments every 6 months. Receives: Behavioral: Usual care |
| TOTAL intervention | Experimental | Participants randomized to this arm will watch the TOTAL intervention video and participate in 1:1 motivational sessions every 6 months. Participants will also complete assessments every 6 months. Receives: Behavioral: Teaching Obesity Treatments to Adult Learners (TOTAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity treatment initiation
Attendance at an individual or group MOVE! visit within 18 months of randomization. Assessed at baseline and 18 months via VA electronic health record review.
Measured: 18 months
Secondary outcomes (4)
Sustained obesity treatment
Attendance at 12 or more MOVE! visits (individual or group) over 18 months. Assessed via VA electronic health record review at baseline and 18 months.
Measured: 18 months
Obesity medication initiation
Presence of an obesity medication on the active medications list within the VA electronic health record. Assessed at baseline and 18months
Measured: 18 months
Bariatric surgery referral
Receipt of a bariatric surgery referral. Assessed at baseline and 18 months via VA electronic health record review.
Measured: 18 months
Weight Change
Patient will weigh themselves on a calibrated scale provided by the study. Patients will enter their weight in an electronic survey sent to them every 6 months (baseline, 6 months, 12months, and 18 months). Participants will also send a picture of their weight on the scale to verify the number.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start23 Jan 2023
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-site, two-arm, parallel randomized control trial to test the effectiveness of the TOTAL intervention vs. usual care on initiation if obesity treatment among Veterans with overweight/obesity.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Luke M Funk, MD MPH, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346575
- Sponsor's protocol ID
- IIR 20-322
- Other IDs
- 2021-1441
- Acronym
- TOTAL
- Status last verified
- Sep 2026
- First submitted
- 18 Apr 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Obesity Treatment Options to Adult Learners (TOTAL): A Multi-site RCT
- ClinicalTrials.gov ID
- NCT05346575
- Acronym / sponsor ID
- TOTAL / IIR 20-322
- Conditions
- Obesity, Overweight
- Keywords
- Bariatric Surgery, Weight-Loss Drugs, Diet, Therapy, Physical Activity, Body Mass Index, Veteran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nearly 8 in 10 Veterans meet criteria for overweight/obesity. Three evidence-based treatment options are available within VA (behavioral weight management [MOVE!], obesity medications, and bariatric surgery).
However, all treatments are significantly underutilized. This study will evaluate the effectiveness of a novel intervention designed to increase obesity treatment initiation and subsequently weight loss within VA. The intervention, Teaching Obesity Treatment Options to Adult Learners (TOTAL), involves an educational video and multiple motivational sessions delivered via telemedicine. If effective, TOTAL could be implemented throughout VA without requiring significant resources and could be integrated into the existing VA behavioral weight management program, MOVE!, which is present at nearly every VA medical center.
Detailed description
Background: Nearly 80% of Veterans meet criteria for overweight (body mass index [BMI] of 25-29.9 kg/m2) or obesity (BMI 30). VA offers three evidence-based obesity treatments at little to no cost to Veterans: MOVE! (to improve dietary intake and physical activity through behavioral modification); obesity medications; and bariatric surgery, but all are significantly underutilized: <10% of Veterans with obesity participate in MOVE!; 2% receive obesity medications; and 0.3% of those who meet BMI criteria for bariatric surgery (BMI 35) undergo it. There is an urgent need to increase use of all three treatments to improve Veteran health.
Significance/Impact: Nearly 4,000,000 Veterans meet BMI criteria for overweight/obesity. It is essential that Veterans with overweight/obesity are aware of the three treatment options and are motivated to pursue them. Currently, no interventions in VA seek to increase use of all three evidence-based obesity treatment options for Veterans not currently participating in MOVE!. The TOTAL intervention (Teaching Obesity Treatment Options to Adults Learners), if effective, would increase obesity treatment initiation for Veterans, lead to greater weight loss, and improve quality of life. Given that TOTAL is deliverable via VA telemedicine, it could be implemented throughout the VA healthcare system without requiring significant resources and could be integrated into the existing VA behavioral weight management program, MOVE!.
Innovation: The research in this proposal would be the first adequately powered RCT in VA testing an intervention to increase use of all three evidence-based obesity treatments: MOVE!, obesity medications, and bariatric surgery. It would leverage the power of the VA electronic health record and would improve access to care by expanding use of a recently developed telemedicine technology - VA Video Connect (VVC) - which was developed by VA researchers. It could be implemented and disseminated efficiently within VA given that MOVE! is available at every VAMC and is supported by NCP.
Specific Aims: Aim 1: Compare the effectiveness of TOTAL vs. usual care for increasing obesity treatment initiation among Veterans with overweight/obesity who are not participating in MOVE!; Aim 2: Compare the effectiveness of TOTAL vs. usual care for increasing sustained MOVE! participation, receipt of an obesity medication prescription or bariatric surgery referral, and weight loss; Aim 3: Inform future dissemination efforts of TOTAL via interviews with key stakeholders, a "Reach" analysis, and cost analysis.
Methodology: Study population: Veterans at two VAMCs, age 18-75 with a BMI 30 or 27-29.9 + an obesity related comorbidity who have not had a MOVE! visit within the past 12 months and thus are not participating in obesity treatment will participate in the RCT; Intervention: The TOTAL intervention consists of an 18-minute obesity treatment educational video and three motivational sessions (all delivered via VA Video Connect [VVC]); Comparison: Usual care (Veterans who have not had a MOVE! visit in the previous 12 months); Outcomes: MOVE! initiation, sustained MOVE! participation, obesity medication use, bariatric surgery referral, weight change; Timing: Primary and secondary outcomes will be measured 18 months post-randomization.
Implementation/Next Steps: Facilitators and barriers to TOTAL implementation will be assessed in Aim 3 interviews with Veteran, provider, and operations stakeholders using the Consolidated Framework for Implementation Research (CFIR). The investigators will also perform "reach" and cost analyses. The investigators will collaborate with NCP to disseminate TOTAL to all VAMCs that have a MOVE! program. The National MOVE! Director will present study results on a national MOVE! call and make presentation materials available on the national MOVE! SharePoint dissemination site. The National MOVE! Director will support MOVE! coordinators who work directly with health behavior coordinators at every VAMC with MOVE!. The study team will consider partnering with NCP to conduct a QUERI National Partnered Evaluation evaluating how TOTAL can be implemented throughout VA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multi-site, two-arm, parallel randomized control trial to test the effectiveness of the TOTAL intervention vs. usual care on initiation if obesity treatment among Veterans with overweight/obesity.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual careParticipants randomized to this arm will receive the usual obesity care, but will complete assessments every 6 months. |
| TOTAL intervention | Experimental | Behavioral: Teaching Obesity Treatments to Adult Learners (TOTAL)Participants randomized to this arm will watch the TOTAL intervention video and participate in 1:1 motivational sessions every 6 months. Participants will also complete assessments every 6 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veteran
- No MOVE! visit attendance within the last 12 months
- No previous bariatric surgery
- Not currently on weight loss medications
- BMI of 30 kg/m2 or 27-29.9 + an obesity-related comorbidity
Key exclusion criteria (6 listed)
- Pregnant or are planning to become pregnant within the study period
- Currently breast feeding
- Have cancer not in remission
- Do not have access to a telephone
- Have severe hearing/visual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teaching Obesity Treatments to Adult Learners (TOTAL)TOTAL includes both video component and motivational telemedicine calls delivered via VA Video Connect (VVC) by a study interventionist. The investigators will invite study participants to watch the 18-minute video at least once. The motivational component of TOTAL will consist of three telemedicine-based (VVC), one-on-one, 30-minute calls at 1 week, 6 months, and 12 months after randomization. This timing was selected so Veterans would have regular interactions with the interventionist within one year of initiating the intervention. Each motivational session will be tailored to where Veterans are in the treatment initiation process. Electronic outcome assessment surveys will be sent to the participants at baseline, at each motivational telemedicine visit, and for the 18 month assessment. | Behavioural | TOTAL intervention |
| Usual careThe usual care group will be electronically sent the 1-week, 6-month, 12-month, 18-month assessments. All usual care participants will be offered the opportunity to watch the educational video component of TOTAL after the final outcome assessment is performed (18 months post-randomization). Veterans in the usual care arm will also have access to the MOVE! program via referrals from the PCP or self-referral to MOVE!. If they initiate treatment in MOVE!, they may progress through MOVE! and receive obesity medications or be referred for bariatric surgery if they choose to do so. | Behavioural | Usual Care |
Primary outcome
Obesity treatment initiation
Time frame: 18 months
Attendance at an individual or group MOVE! visit within 18 months of randomization. Assessed at baseline and 18 months via VA electronic health record review.
4 secondary outcomes
Sustained obesity treatment
Time frame: 18 months
Obesity medication initiation
Time frame: 18 months
Bariatric surgery referral
Time frame: 18 months
Weight Change
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke M Funk, MD MPH principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching Obesity Treatments to Adult Learners (TOTAL) in people with Obesity and Overweight, run by VA Office of Research and Development at 2 sites 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 5 inclusion and 6 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Obesity treatment initiation (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.