NCT04878289

Brief Summary

The goal of this study is to assess the feasibility and acceptability of Teaching Obesity Treatment Options to Adult Learners (TOTAL intervention), which includes an educational video about obesity treatment options within VA in conjunction with three telemedicine motivational sessions to increase obesity treatment initiation. 10 participants will be recruited from the Madison VA Medical Center. Participation involves 3.5 hours of total time with study follow up to 18 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

2.2 years

First QC Date

May 4, 2021

Last Update Submit

June 26, 2023

Conditions

Overweight and Obesity

Keywords

telemedicineVeterans Health AdministrationVHAbehavioral weight management

Outcome Measures

Primary Outcomes (5)

  • Recruitment: Number of Participants Consented Compared to Number of Recruitment Letters Sent

    The ratio of consented participants to number of recruitment letters sent will measure the level of recruitment in this pilot study.

    up to 18 months

  • Retention: Number of Participants Who Completed the Intervention Compared to Number of Participants Consented

    The ratio of participants who watched the video and completed all three telemedicine sessions to the number of participants consented will measure the level of retention in this pilot study.

    up to 18 months

  • Acceptability

    Participants will be asked about their perceptions of watching the video and completing the motivational sessions via VVC at each session (1 week, 6 months, 12 months). Participant perceptions will be summarized qualitatively.

    1 week

  • Acceptability

    Participants will be asked about their perceptions of watching the video and completing the motivational sessions via VVC at each session (1 week, 6 months, 12 months). Participant perceptions will be summarized qualitatively.

    6 months

  • Acceptability

    Participants will be asked about their perceptions of watching the video and completing the motivational sessions via VVC at each session (1 week, 6 months, 12 months). Participant perceptions will be summarized qualitatively.

    12 months

Secondary Outcomes (1)

  • Number of Participants who initiated Obesity Treatment

    up to 18 months

Study Arms (1)

TOTAL Intervention

EXPERIMENTAL

TOTAL video and participate in three one-on-one, 30-minute motivational sessions via VVC at 1-week, 6-months, and 12-months

Behavioral: TOTAL with Motivational Telemedicine Sessions

Interventions

TOTAL with Motivational Telemedicine SessionsBEHAVIORAL

Teaching Obesity Treatment Options to Adult Learners Educational Video with 3, 30 minute motivational sessions at 1 week, 6 months, and 12 months after viewing video

TOTAL Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran
  • BMI of 30 or greater, or
  • BMI of 27 or greater with an obesity-related comorbidity
  • Primary Care Physician visit within the past 12 months

You may not qualify if:

  • Participation in the MOVE! program within the past 12 months
  • Receipt of a weight-loss medication within the past 12 months
  • Bariatric surgery referral within the past 12 months
  • Has had bariatric surgery
  • Previous stomach or small intestine surgery (at discretion of the PI)
  • Severe medical condition that would preclude meaningful participation in the study
  • Pregnancy or intended pregnancy during the study period
  • Current breast feeding
  • Cancer not in remission
  • Lack of regular access to a telephone
  • Lack of regular access to internet-connected device with a microphone such as a computer/laptop/tablet/smart phone
  • Non-English speaking
  • Hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William S. Middleton VA Hospital

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luke M Funk, MD, MPH, FACS

    William S. Middleton VA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 7, 2021

Study Start

April 15, 2021

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)