Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions

Obesity Clinical Trial

— RE-TOOL  

Official title:

Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions (RE-TOOL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710510
• Other study ID #: STUDY00147574
• Secondary ID: 1R01CA268034-01
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: August 2026

Study information

• Verified date: June 2024
• Source: University of Kansas Medical Center
• Contact: Stacy J McCrea-Robertson, MS
• Phone: 9139456941
• Email: smccrea-robertson[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Behavioral:
• Local Care + Model
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 Model
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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent weight loss at 18 months	Mean percent weight loss at 18 months; unadjusted	18 months
Secondary	Percent weight loss at 6 months	Mean percent weight loss at 6 months; unadjusted	6 months
Secondary	Percent weight loss at 12 months	Mean percent weight loss at 12 months; unadjusted	12 months
Secondary	Weight loss (kg) at 6 months	Mean weight loss (kg) at 6 months; unadjusted	6 months
Secondary	Weight loss (kg) at 12 months	Mean weight loss (kg) at 12 months; unadjusted	12 months
Secondary	Weight loss (kg) at 18 months	Mean weight loss (kg) at 18 months; unadjusted	18 months
Secondary	Proportion achieving =5% weight loss at 6 months	Proportion achieving =5% weight loss at 6 months; unadjusted	6 months
Secondary	Proportion achieving =5% weight loss at 12 months	Proportion achieving =5% weight loss at 12 months; unadjusted	12 months
Secondary	Proportion achieving =5% weight loss at 18 months	Proportion achieving =5% weight loss at 18 months; unadjusted	18 months
Secondary	Proportion achieving =10% weight loss at 6 months	Proportion achieving =10% weight loss at 6 months; unadjusted	6 months
Secondary	Proportion achieving =10% weight loss at 12 months	Proportion achieving =10% weight loss at 12 months; unadjusted	12 months
Secondary	Proportion achieving =10% weight loss at 18 months	Proportion achieving =10% weight loss at 18 months; unadjusted	18 months
Secondary	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).	Baseline and 6 months
Secondary	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).	Baseline and 12 months
Secondary	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).	Baseline and 18 months
Secondary	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.	Baseline and 6 months
Secondary	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.	Baseline and 12 months
Secondary	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.	Baseline and 18 months
Secondary	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.	Baseline and 6 months
Secondary	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.	Baseline and 12 months
Secondary	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.	Baseline and 18 months
Secondary	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.	Baseline and 6 months
Secondary	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.	Baseline and 12 months
Secondary	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.	Baseline and 18 months
Secondary	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.	Baseline and 6 months
Secondary	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.	Baseline and 12 months
Secondary	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.	Baseline and 18 months