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Teaching Obesity Treatment Options to Adult Learners Trial

A Randomized Pilot Study of a Video-based Obesity Educational Intervention (CDA 15-060)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03856320
Acronym
TOTAL
Enrollment
42
Registered
2019-02-27
Start date
2019-05-13
Completion date
2020-02-18
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Patient Education, Weight Loss

Keywords

Obesity, Patient Education, Weight Loss

Brief summary

Obesity is the second leading cause of death in the U.S. The treatment of obesity and its related health issues, including cardiovascular disease and diabetes, exceeds $150 billion annually. Morbidly or severely obese patients - defined by a body mass index \[BMI\] of \>35 kg/m2 or greater - are especially high risk for serious complications due to their weight. Within the Veterans Health Administration (VA) system, nearly 600,000 patients are severely obese. These Veterans create significant costs for the VA system, experience poorer quality of life, and have shortened lifespans. Bariatric surgery is the most effective treatment for severe obesity for weight loss, resolving weight-related health issues, and quality of life. Bariatric surgery is supported as a treatment option by many national societies, including those representing primary care and endocrinology. However, less than 1% of Veterans who qualify for bariatric surgery undergo it. Reasons for low utilization are unclear, although the investigators' preliminary research suggests that there are various patient, provider and system level barriers to severe obesity care. The goal of this study is to pilot-test an educational video that aligns patient preferences with treatment options to improve the care that severely obese Veterans receive.

Detailed description

Obesity is the second leading cause of death in the U.S. The treatment of obesity and its related comorbidities, including cardiovascular disease and diabetes, exceeds $150 billion annually. Morbidly or severely obese patients - defined by a body mass index \[BMI\] of \>35 kg/m2 or greater - are especially high risk for serious complications due to the metabolic and physiologic derangements that occur with severe obesity. Within the Veterans Health Administration (VA) system, nearly 600,000 patients are severely obese. These Veterans exert significant costs on the VA system, experience poorer quality of life, and have shortened lifespans. Bariatric surgery is the most effective treatment for severe obesity for weight loss, comorbidity resolution, and quality of life. Bariatric surgery is supported as a treatment option by many national societies, including those representing primary care and endocrinology. However, less than 1% of Veterans who qualify for bariatric surgery undergo it. Reasons for low utilization are unclear, although the investigators' preliminary research suggests that there are various patient, provider and system level barriers to severe obesity care. The goal of this study is to pilot-test an educational video that aligns patient preferences with treatment options to optimize the care that severely obese Veterans receive.

Interventions

BEHAVIORALEducational Video

An educational video describing obesity treatment options available in the VA.

Sponsors

The Clowes Fund
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcomes assessor will be blinded to the patient's allocation.

Intervention model description

An educational video describing obesity treatment options available in the VA.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Veterans scheduled to attend an in-person MOVE! visit led by a dietitian at the main VA hospital.

Exclusion criteria

* No access to telephone, doesn't speak English as their primary language, has undergone bariatric surgery

Design outcomes

Primary

MeasureTime frameDescription
Recruitment1 yearThe proportion of patients who were contacted by the study team who also consented and provided baseline assessment data.
Retention7-14 daysThe proportion of patients who consented and completed the baseline assessment who also completed the post assessment.

Countries

United States

Participant flow

Participants by arm

ArmCount
Usual Care
Patient attends a MOVE! visit (weight management visit).
20
Intervention
Patient attends a MOVE! visit (weight management visit) and watches an educational video describing obesity treatment options available in the VA. Educational Video: An educational video describing obesity treatment options available in the VA.
22
Total42

Baseline characteristics

CharacteristicUsual CareInterventionTotal
Age, Continuous57.5 years
STANDARD_DEVIATION 13.1
60.7 years
STANDARD_DEVIATION 10.9
59.2 years
STANDARD_DEVIATION 11.9
BMI40.7 kg/m^2
STANDARD_DEVIATION 7.8
43.1 kg/m^2
STANDARD_DEVIATION 5.3
41.9 kg/m^2
STANDARD_DEVIATION 6.6
Race/Ethnicity, Customized
Black, non-Hispanic
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Hispanic
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Other
2 Participants2 Participants4 Participants
Race/Ethnicity, Customized
White, non-Hispanic
18 Participants19 Participants37 Participants
Region of Enrollment
United States
20 participants22 participants42 participants
Sex: Female, Male
Female
2 Participants5 Participants7 Participants
Sex: Female, Male
Male
18 Participants17 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 22
other
Total, other adverse events
0 / 200 / 22
serious
Total, serious adverse events
0 / 200 / 22

Outcome results

Primary

Recruitment

The proportion of patients who were contacted by the study team who also consented and provided baseline assessment data.

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
All Attempted RecruitmentRecruitment42 Participants
Primary

Retention

The proportion of patients who consented and completed the baseline assessment who also completed the post assessment.

Time frame: 7-14 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
All Attempted RecruitmentRetention40 Participants

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026