ObesityRE-TOOLNCT05710510
Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions
A study testing Local Care + Model and Team Care Model in people with Obesity and Obesity, Morbid, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare two methods for managing obesity in rural primary care patients. The first method includes quarterly 1:1 meetings with the participant and their primary care provider and the second includes a group lifestyle intervention over Zoom paired with quarterly team meetings with the… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obesity, Obesity, Morbid
- What is being tested?
- Local Care + Model and Team Care Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2023to 21 Sep 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI: >= 30 kg/m2
- Rural resident
- English speaking
- Physician clearance to participate
- Able to walk without assistance
- Seen at least once in their primary care clinic within the past year
- Internet access or smart phone (to access smart scale for weight measurement)
Who cannot join
- History of myocardial infarction within last six months
- History of stroke within last six months
- History of new cancer diagnosis within last six months
- History of bariatric surgery within the last two years
- Pregnancy within last 6 months or planned within the next 18 months
- Currently breastfeeding
Show all 11Show fewer
- End stage renal disease, currently on dialysis, or anticipated dialysis or renal transplant within the next 18 months
- End stage liver disease, or anticipated liver transplant within the next 18 months
- Currently enrolled or planning to enroll in another study where weight loss is targeted or weight fluctuation is expected
- Currently planning to move outside of current provider area, or leave primary care clinic within the next 18 months
- Another household member is already participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Missouri, 66160
About this study
Official title: Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions (RE-TOOL)
The purpose of this study is to compare two methods for managing obesity in rural primary care patients. The first method includes quarterly 1:1 meetings with the participant and their primary care provider and the second includes a group lifestyle intervention over Zoom paired with quarterly team meetings with the participant, their primary care provider and their lifestyle coach, the coach joining via Zoom. Investigators will evaluate which method is best at helping participants lose weight over 18 months.
Read the detailed description
Obesity increases risk for 13 types of cancer and now affects over 40% of the U.S. adult population, with even higher prevalence among rural Americans. Rural residents often lack access to weight control programs and food and physical activity resources that promote healthy lifestyles, especially in small or remote rural areas. It is important for obesity treatment to be offered in rural primary care, yet local resources are often lacking. Medical management by a primary care provider (PCP) during behavioral weight loss is essential to address co-morbid medical conditions, evaluate obesogenic medications, and explore options for guideline-recommended pharmacotherapy and surgical treatment. This study is designed to enhance sustainable access to obesity treatment in rural communities by offering education to local providers on obesity management and integrating team-based care into an obesity treatment model through telemedicine.
The two methods of obesity treatment to be studied are:
- Local Care + Arm: Quarterly clinic visits with the participants and their local primary care provider
- Team Care Arm: An intensive group lifestyle intervention offered by a lifestyle coach via Zoom, paired with quarterly clinic visits with the participant, their local primary care provider and the lifestyle coach, the coach joining via telemedicine.
Participants will be in the study about 18 months. Participants in the Local Care + arm will be asked to complete 4 data collection visits and 6 quarterly clinic visits. Participants in the Team Care arm will be asked to complete 4 data collection visits, 30 counseling sessions and 6 quarterly clinic visits.
- Conditions
- Obesity, Obesity, Morbid
- Being tested
- Local Care + Model, Team Care Model
- Keywords
- Weight loss, Weight management, Behavioral intervention, Medical management of obesity, Team care
- Medical subject headings
- Obesity, Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Care + ModelBehavioural
Local primary care providers receive training in medical management of obesity prior to the start of the participant intervention.
Participants receive 6 quarterly clinic visits with their local primary care provider focused on medical management of obesity.
Team Care ModelBehavioural
Local primary care providers receive training in medical management of obesity prior to the start of the participant intervention.
Participants receive an intensive 18-month group lifestyle intervention (30 total sessions) led by a study lifestyle coach via Zoom, and 6 quarterly 1:1 visits via Zoom with their lifestyle coach. Participants also receive 6 quarterly clinic visits with their local primary care provider; the study lifestyle coach joins the visits via telemedicine. All three parties may meet via telemedicine if needed. The group lifestyle intervention is led by obesity treatment specialists with relevant graduate training and experience.
| Study group | Role | What they receive |
|---|---|---|
| Local Care + Model | Active comparator | Quarterly clinic visits with a local primary care provider Receives: Behavioral: Local Care + Model |
| Team Care Model | Active comparator | An intensive group lifestyle intervention led by a lifestyle coach via Zoom, paired with quarterly clinic visits with a local primary care provider and the lifestyle coach, the coach joining via telemedicine. Receives: Behavioral: Team Care Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight loss at 18 months
Mean percent weight loss at 18 months; unadjusted
Measured: 18 months
Secondary outcomes (26)
Percent weight loss at 6 months
Mean percent weight loss at 6 months; unadjusted
Measured: 6 months
Percent weight loss at 12 months
Mean percent weight loss at 12 months; unadjusted
Measured: 12 months
Weight loss (kg) at 6 months
Mean weight loss (kg) at 6 months; unadjusted
Measured: 6 months
Weight loss (kg) at 12 months
Mean weight loss (kg) at 12 months; unadjusted
Measured: 12 months
Weight loss (kg) at 18 months
Mean weight loss (kg) at 18 months; unadjusted
Measured: 18 months
Proportion achieving ≥5% weight loss at 6 months
Proportion achieving ≥5% weight loss at 6 months; unadjusted
Measured: 6 months
Proportion achieving ≥5% weight loss at 12 months
Proportion achieving ≥5% weight loss at 12 months; unadjusted
Measured: 12 months
Proportion achieving ≥5% weight loss at 18 months
Proportion achieving ≥5% weight loss at 18 months; unadjusted
Measured: 18 months
Proportion achieving ≥10% weight loss at 6 months
Proportion achieving ≥10% weight loss at 6 months; unadjusted
Measured: 6 months
Proportion achieving ≥10% weight loss at 12 months
Proportion achieving ≥10% weight loss at 12 months; unadjusted
Measured: 12 months
Proportion achieving ≥10% weight loss at 18 months
Proportion achieving ≥10% weight loss at 18 months; unadjusted
Measured: 18 months
Change in diet quality at 6 months
Mean change in diet quality, measured by Rapid Eating Assessment for Participant--Shortened Version (REAPS) at 6 months; unadjusted. The REAPS estimates diet quality through 13 items which assess weekly eating habits. Possible scores range from 13 (worst diet quality) to 39 (best diet quality).
Measured: Baseline and 6 months
Change in diet quality at 12 months
Mean change in diet quality, measured by Rapid Eating Assessment for Participant--Shortened Version (REAPS) at 12 months; unadjusted. The REAPS estimates diet quality through 13 items which assess weekly eating habits. Possible scores range from 13 (worst diet quality) to 39 (best diet quality).
Measured: Baseline and 12 months
Change in diet quality at 18 months
Mean change in diet quality, measured by Rapid Eating Assessment for Participant--Shortened Version (REAPS) at 18 months; unadjusted. The REAPS estimates diet quality through 13 items which assess weekly eating habits. Possible scores range from 13 (worst diet quality) to 39 (best diet quality).
Measured: Baseline and 18 months
Change in physical activity at 6 months
Mean change in MET-HOURS per week measured by Modifiable Activity Questionnaire (MAQ) at 6 months; unadjusted. The MAQ will be used to measure participants' leisure-time physical activity over the past 7 days. Leisure-time physical activity will be calculated as the Metabolic Equivalent of Task (MET) hours per week (MET-hr/week) and estimated by multiplying time (in hours) spent in an activity by the activities estimated MET and summing across all activities.
Measured: Baseline and 6 months
Change in physical activity at 12 months
Mean change in MET-HOURS per week measured by Modifiable Activity Questionnaire (MAQ) at 12 months; unadjusted. The MAQ will be used to measure participants' leisure-time physical activity over the past 7 days. Leisure-time physical activity will be calculated as the Metabolic Equivalent of Task (MET) hours per week (MET-hr/week) and estimated by multiplying time (in hours) spent in an activity by the activities estimated MET and summing across all activities.
Measured: Baseline and 12 months
Change in physical activity at 18 months
Mean change in MET-HOURS per week measured by Modifiable Activity Questionnaire (MAQ) at 18 months; unadjusted. The MAQ will be used to measure participants' leisure-time physical activity over the past 7 days. Leisure-time physical activity will be calculated as the Metabolic Equivalent of Task (MET) hours per week (MET-hr/week) and estimated by multiplying time (in hours) spent in an activity by the activities estimated MET and summing across all activities.
Measured: Baseline and 18 months
Change in physical quality of life at 6 months
Mean change in physical quality of life, measured by SF-12 at 6 months; unadjusted. The Short Form Health Survey (SF-12) is a general quality of life measure with a physical functioning summary score. Scores range from 0 to 100 with higher scores representing better functioning.
Measured: Baseline and 6 months
Change in physical quality of life at 12 months
Mean change in physical quality of life, measured by SF-12 at 12 months; unadjusted. The Short Form Health Survey (SF-12) is a general quality of life measure with a physical functioning summary score. Scores range from 0 to 100 with higher scores representing better functioning.
Measured: Baseline and 12 months
Change in physical quality of life at 18 months
Mean change in physical quality of life, measured by SF-12 at 18 months; unadjusted. The Short Form Health Survey (SF-12) is a general quality of life measure with a physical functioning summary score. Scores range from 0 to 100 with higher scores representing better functioning.
Measured: Baseline and 18 months
Change in mental quality of life at 6 months
Mean change in mental quality of life, measured by SF-12 at 6 months; unadjusted. The Short Form Health Survey (SF-12) is a general quality of life measure with a mental functioning summary score. Scores range from 0 to 100 with higher scores representing better functioning.
Measured: Baseline and 6 months
Change in mental quality of life at 12 months
Mean change in mental quality of life, measured by SF-12 at 12 months; unadjusted. The Short Form Health Survey (SF-12) is a general quality of life measure with a mental functioning summary score. Scores range from 0 to 100 with higher scores representing better functioning.
Measured: Baseline and 12 months
Change in mental quality of life at 18 months
Mean change in mental quality of life, measured by SF-12 at 18 months; unadjusted. The Short Form Health Survey (SF-12) is a general quality of life measure with a mental functioning summary score. Scores range from 0 to 100 with higher scores representing better functioning.
Measured: Baseline and 18 months
Change in weight-related quality of life at 6 months
Mean change in total quality of life, measured by Impact of Weight on Quality of Life-Lite (IWQOL-L) at 6 months; unadjusted. The IWQOL-L measure consists of a total score and five subscales--physical function, self-esteem, sexual life, public distress, and work. The total score ranges from 0 to 100 with higher scores indicating better quality of life.
Measured: Baseline and 6 months
Change in weight-related quality of life at 12 months
Mean change in total quality of life, measured by Impact of Weight on Quality of Life-Lite (IWQOL-L) at 12 months; unadjusted. The IWQOL-L measure consists of a total score and five subscales--physical function, self-esteem, sexual life, public distress, and work. The total score ranges from 0 to 100 with higher scores indicating better quality of life.
Measured: Baseline and 12 months
Change in weight-related quality of life at 18 months
Mean change in total quality of life, measured by Impact of Weight on Quality of Life-Lite (IWQOL-L) at 18 months; unadjusted. The IWQOL-L measure consists of a total score and five subscales--physical function, self-esteem, sexual life, public distress, and work. The total score ranges from 0 to 100 with higher scores indicating better quality of life.
Measured: Baseline and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start10 Mar 2023
- Primary completion21 Sep 2026
- Study completion21 Sep 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 University of Kansas Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christie Befort, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710510
- Sponsor's protocol ID
- STUDY00147574
- Other IDs
- 1R01CA268034-01
- Acronym
- RE-TOOL
- Status last verified
- Oct 2026
- First submitted
- 29 Dec 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A clean, de-identified copy of the final dataset will be created within 30 days of primary outcome paper publication. Data will be made available to researchers upon email request to the Principal Investigator. We will convert date of birth to age, and other identifiers (e.g, address, zip code, state) will be removed. Data and associated documentation will be made available to users under a data-sharing agreement that provides for: (1) a commitment to use the data solely for research purposes and to not identify individual participants during use or publication; (2) a commitment to secure the data using appropriate computer technology upon receipt; and (3) a commitment to destroy or return the data to the KU Medical Center after analyses are completed. Data will be saved as SAS or SPSS files and provided to requesters via KUMC's Secure File Transfer service. A copy of our analytic code used to generate our primary outcomes paper(s) will be made available on request in the same fashion.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions (RE-TOOL)
- ClinicalTrials.gov ID
- NCT05710510
- Acronym / sponsor ID
- RE-TOOL / STUDY00147574
- Conditions
- Obesity, Obesity, Morbid
- Keywords
- Weight loss, Weight management, Behavioral intervention, Medical management of obesity, Team care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 21 Sep 2026 (actual)
- Study completion
- 21 Sep 2026 (actual)
- First posted
- 2 Feb 2023 (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.
The purpose of this study is to compare two methods for managing obesity in rural primary care patients. The first method includes quarterly 1:1 meetings with the participant and their primary care provider and the second includes a group lifestyle intervention over Zoom paired with quarterly team meetings with the participant, their primary care provider and their lifestyle coach, the coach joining via Zoom. Investigators will evaluate which method is best at helping participants lose weight over 18 months.
Detailed description
Obesity increases risk for 13 types of cancer and now affects over 40% of the U.S. adult population, with even higher prevalence among rural Americans. Rural residents often lack access to weight control programs and food and physical activity resources that promote healthy lifestyles, especially in small or remote rural areas. It is important for obesity treatment to be offered in rural primary care, yet local resources are often lacking. Medical management by a primary care provider (PCP) during behavioral weight loss is essential to address co-morbid medical conditions, evaluate obesogenic medications, and explore options for guideline-recommended pharmacotherapy and surgical treatment. This study is designed to enhance sustainable access to obesity treatment in rural communities by offering education to local providers on obesity management and integrating team-based care into an obesity treatment model through telemedicine.
The two methods of obesity treatment to be studied are:
- Local Care + Arm: Quarterly clinic visits with the participants and their local primary care provider
- Team Care Arm: An intensive group lifestyle intervention offered by a lifestyle coach via Zoom, paired with quarterly clinic visits with the participant, their local primary care provider and the lifestyle coach, the coach joining via telemedicine.
Participants will be in the study about 18 months. Participants in the Local Care + arm will be asked to complete 4 data collection visits and 6 quarterly clinic visits. Participants in the Team Care arm will be asked to complete 4 data collection visits, 30 counseling sessions and 6 quarterly clinic visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Care + Model | Active comparator | Behavioral: Local Care + ModelQuarterly clinic visits with a local primary care provider |
| Team Care Model | Active comparator | Behavioral: Team Care ModelAn intensive group lifestyle intervention led by a lifestyle coach via Zoom, paired with quarterly clinic visits with a local primary care provider and the lifestyle coach, the coach joining via telemedicine. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI: >= 30 kg/m2
- Rural resident
- English speaking
- Physician clearance to participate
- Able to walk without assistance
Key exclusion criteria (11 listed)
- History of myocardial infarction within last six months
- History of stroke within last six months
- History of new cancer diagnosis within last six months
- History of bariatric surgery within the last two years
- Pregnancy within last 6 months or planned within the next 18 months
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 |
|---|---|---|
| Local Care + ModelLocal primary care providers receive training in medical management of obesity prior to the start of the participant intervention. Participants receive 6 quarterly clinic visits with their local primary care provider focused on medical management of obesity. | Behavioural | Local Care + Model |
| Team Care ModelLocal primary care providers receive training in medical management of obesity prior to the start of the participant intervention. Participants receive an intensive 18-month group lifestyle intervention (30 total sessions) led by a study lifestyle coach via Zoom, and 6 quarterly 1:1 visits via Zoom with their lifestyle coach. Participants also receive 6 quarterly clinic visits with their local primary care provider; the study lifestyle coach joins the visits via telemedicine. All three parties may meet via telemedicine if needed. The group lifestyle intervention is led by obesity treatment specialists with relevant graduate training and experience. | Behavioural | Team Care Model |
Primary outcome
Percent weight loss at 18 months
Time frame: 18 months
Mean percent weight loss at 18 months; unadjusted
26 secondary outcomes
Percent weight loss at 6 months
Time frame: 6 months
Percent weight loss at 12 months
Time frame: 12 months
Weight loss (kg) at 6 months
Time frame: 6 months
Weight loss (kg) at 12 months
Time frame: 12 months
Weight loss (kg) at 18 months
Time frame: 18 months
Proportion achieving ≥5% weight loss at 6 months
Time frame: 6 months
Proportion achieving ≥5% weight loss at 12 months
Time frame: 12 months
Proportion achieving ≥5% weight loss at 18 months
Time frame: 18 months
Proportion achieving ≥10% weight loss at 6 months
Time frame: 6 months
Proportion achieving ≥10% weight loss at 12 months
Time frame: 12 months
Proportion achieving ≥10% weight loss at 18 months
Time frame: 18 months
Change in diet quality at 6 months
Time frame: Baseline and 6 months
Change in diet quality at 12 months
Time frame: Baseline and 12 months
Change in diet quality at 18 months
Time frame: Baseline and 18 months
Change in physical activity at 6 months
Time frame: Baseline and 6 months
Change in physical activity at 12 months
Time frame: Baseline and 12 months
Change in physical activity at 18 months
Time frame: Baseline and 18 months
Change in physical quality of life at 6 months
Time frame: Baseline and 6 months
Change in physical quality of life at 12 months
Time frame: Baseline and 12 months
Change in physical quality of life at 18 months
Time frame: Baseline and 18 months
Change in mental quality of life at 6 months
Time frame: Baseline and 6 months
Change in mental quality of life at 12 months
Time frame: Baseline and 12 months
Change in mental quality of life at 18 months
Time frame: Baseline and 18 months
Change in weight-related quality of life at 6 months
Time frame: Baseline and 6 months
Change in weight-related quality of life at 12 months
Time frame: Baseline and 12 months
Change in weight-related quality of life at 18 months
Time frame: Baseline and 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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. A clean, de-identified copy of the final dataset will be created within 30 days of primary outcome paper publication. Data will be made available to researchers upon email request to the Principal Investigator. We will convert date of birth to age, and other identifiers (e.g, address, zip code, state) will be removed. Data and associated documentation will be made available to users under a data-sharing agreement that provides for: (1) a commitment to use the data solely for research purposes and to not identify individual participants during use or publication; (2) a commitment to secure the data using appropriate computer technology upon receipt; and (3) a commitment to destroy or return the data to the KU Medical Center after analyses are completed. Data will be saved as SAS or SPSS files and provided to requesters via KUMC's Secure File Transfer service. A copy of our analytic code used to generate our primary outcomes paper(s) will be made available on request in the same fashion.
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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.
Christie Befort, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Care + Model and Team Care Model in people with Obesity and Obesity, Morbid, run by University of Kansas Medical Center 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 7 inclusion and 11 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 27 Oct 2026. 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?
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?
Percent weight loss at 18 months (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 27 Oct 2026.