ObesityRE-POWERNCT02456636

Rural Engagement in Primary Care for Optimizing Weight Reduction

A study testing Fee-for-Service Model (FFS, In clinic individual visits), Patient Centered Medical Home (PCMH, In clinic group visits) and Disease Management (DM, Phone group visits) in people with Obesity, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare three methods for managing obesity in rural patients, to see which method will result in patients being able to attain their weight loss goal and maintain that weight loss. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Obesity
What is being tested?: Fee-for-Service Model (FFS, In clinic individual visits), Patient Centered Medical Home (PCMH, In clinic group visits) and Disease Management (DM, Phone group visits)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,432 participants
Where: 1 siteUnited States
Study dates: 15 Feb 2016to 30 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 between 30 kg/m2 and 45 kg/m2.
Live in a rural location.
Have clearance from their primary care provider to participate in a diet and exercise weight control intervention.
Have access to a telephone.
One individual per household will be permitted to enroll in the study.

Who cannot join

History of heart attack in the last six months, stroke in the last six months, or new cancer diagnosis in the last six months.
History of bariatric surgery or planning bariatric surgery in the next two years.
Pregnancy within the last six months or planned within the next two years or currently pregnant or lactating.
Serious medical conditions where weight loss is contraindicated.
End stage renal disease or end stage liver disease.
Other medical contraindications as determined by the patient's primary care physician (PCP); documented PCP clearance will be obtained.

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Participants who are already enrolled in, or planning to enroll in another research study where weight loss is targeted.
Participants who plan to relocate outside of their provider's service area or who plan to leave their primary care clinic in the next 2 years.
Unable to read and understand English.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER)

Read the detailed description

Nearly 20% of the U.S. population lives in rural communities. Rural residents suffer at a higher rate from obesity and obesity-related illnesses, including diabetes, heart disease, and arthritis. Local primary care physicians are an important resource for treating obesity in rural areas because of a lack of other community resources.

This study is looking at how effective current, real-world primary care treatment models are in helping rural residents lose weight and maintain that weight loss. Physician clinics will be randomized (like picking numbers from a hat) to conduct one of the three methods. The method a participant is part of will depend on the method their physician's clinic is randomized to. The three methods involved in this study are:

Individual weight-management counseling in person (in clinic individual visits)
Group weight-management counseling, both in person and by telephone; the latter if preferred by the group (in clinic group visits)
Group weight-management counseling by telephone (phone group visits)

Participants will be in the study about 24 months. The number of in-person clinic visits and phone calls each participant will be asked to complete depends on the method.

Conditions: Obesity
Being tested: Fee-for-Service Model (FFS, In clinic individual visits), Patient Centered Medical Home (PCMH, In clinic group visits), Disease Management (DM, Phone group visits)
Keywords: Weight loss, Weight management, Diabetes, Heart disease
Medical subject headings: Obesity, Weight Loss, Diabetes Mellitus, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fee-for-Service Model (FFS, In clinic individual visits)Behavioural
Also called Individual weight management counseling
To be performed by participant's doctor or other healthcare professional in their doctor's office.
Patient Centered Medical Home (PCMH, In clinic group visits)Behavioural
Also called Group weight management counseling (in-person and telephone)
To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.
Disease Management (DM, Phone group visits)Behavioural
Also called Group weight management counseling (telephone)
To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.

Study groups in NCT02456636
Study group	Role	What they receive
Fee-for-Service Model (FFS, In clinic individual visits)	Active comparator	Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. Receives: Behavioral: Fee-for-Service Model (FFS, In clinic individual visits)
Patient Centered Medical Home (PCMH, In clinic group visits)	Active comparator	Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers. Receives: Behavioral: Patient Centered Medical Home (PCMH, In clinic group visits)
Disease Management (DM, Phone group visits)	Active comparator	Participants will take part in group weight-management counseling by telephone. Receives: Behavioral: Disease Management (DM, Phone group visits)

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation
Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.
Measured: Baseline and 6, 18 and 24 months
Mean Weight Change Over 24 Months; Adjusted
Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Adjusted for affiliation, sex, race/ethnicity, education, diabetes, cardiovascular disease, and travel time to clinic.
Measured: Baseline and 6, 18 and 24 months

Secondary outcomes (13)

Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation
Comparison in percent weight loss from baseline of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.
Measured: Baseline and 6, 18 and 24 months
Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation
Mean change in systolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation.
Measured: Baseline and 6, 18 and 24 months
Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation
Mean change in diastolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation.
Measured: Baseline and 6, 18 and 24 months
Mean Change in Fasting Glucose; Unadjusted Except for Affiliation
Mean change in fasting glucose will be compared across all treatment arms; unadjusted except for affiliation.
Measured: Baseline and 6 and 24 months
Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation
Mean change in fasting cholesterol will be compared across all treatment arms; unadjusted except for affiliation.
Measured: Baseline and 6 and 24 months
Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation
Mean change in fasting triglycerides will be compared across all treatment arms; unadjusted except for affiliation.
Measured: Baseline and 6 and 24 months
Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation
Mean change in fasting low density lipoprotein (LDL) will be compared across all treatment arms; unadjusted except for affiliation.
Measured: Baseline and 6 and 24 months
Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation
Mean change in fasting high density lipoprotein (HDL) will be compared across all treatment arms; unadjusted except for affiliation.
Measured: Baseline and 6 and 24 months
Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation
Change in physical quality of life score, measured by SF-12. The Short Form Health Survey (SF-12) is a general quality of life measure with mental functioning and physical functioning summary scores. Each is scored from 0 to 100 with higher scores representing better functioning. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.
Measured: Baseline and 6 and 24 months
Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation
Mean change in mental quality of life score, measured by SF-12. The Short Form Health Survey (SF-12) is a general quality of life measure with mental functioning and physical functioning summary scores. Each is scored from 0 to 100 with higher scores representing better functioning. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.
Measured: Baseline and 6 and 24 months
Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation
The Impact of Weight on Quality of Life-Lite (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. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.
Measured: Baseline and 6 and 24 months
Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation
Measured using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 (better) to 21 (worse). Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.
Measured: Baseline and 6 and 24 months
Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation
Mean change in stress measured using the Perceived Stress Scale (PSS). Scores range from 0 to 40. Higher numbers represent greater levels of stress. Measures will be collected at baseline, 6 months, 18 months and 24 months. Unadjusted except for affiliation.
Measured: Baseline and 6, 18 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201630 Dec 2019

First posted28 May 2015 (estimated)
Study start15 Feb 2016
Primary completion30 Dec 2019
Study completion30 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
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: 1,432 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02456636
Sponsor's protocol ID: RE-POWER
Other IDs: PCORI-1402-09413, STUDY00002654
Acronym: RE-POWER
Status last verified: Dec 2020
First submitted: 26 May 2015
Last updated: 7 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Bernal J, Wick JA, Gajewski B, Greiner KA, Wu J, Befort C. Weight-Related Self-Esteem, Group Behavioral Therapy, and Weight Loss. Obesity (Silver Spring). 2026 Aug;34(8):1541-1544. doi: 10.1002/oby.70257. Epub 2026 Jul 8.
PubMed 42420235
Saint Onge JM, Fagan M, Befort CA. The association between the obesogenic environment and 6-month and 24-month weight change in a rural weight loss intervention trial in the United States. Prev Med. 2022 May;158:107040. doi: 10.1016/j.ypmed.2022.107040. Epub 2022 Apr 7.
PubMed 35398370
Tang F, Befort CA, Wick J, Gajewski BJ. Unifying the analysis of continuous and categorical measures of weight loss and incorporating group effect: a secondary re-analysis of a large cluster randomized clinical trial using Bayesian approach. BMC Med Res Methodol. 2022 Jan 26;22(1):28. doi: 10.1186/s12874-021-01499-0.
PubMed 35081912
Katzmarzyk PT, Apolzan JW, Gajewski B, Johnson WD, Martin CK, Newton RL Jr, Perri MG, VanWormer JJ, Befort CA. Weight loss in primary care: A pooled analysis of two pragmatic cluster-randomized trials. Obesity (Silver Spring). 2021 Dec;29(12):2044-2054. doi: 10.1002/oby.23292. Epub 2021 Oct 29.
PubMed 34714976
Goessl CL, VanWormer JJ, Pathak RD, Ellerbeck EF, Befort CA. Affective disorders, weight change, and patient engagement in a rural behavioral weight loss trial. Prev Med. 2021 Nov;152(Pt 2):106698. doi: 10.1016/j.ypmed.2021.106698. Epub 2021 Jun 24.
PubMed 34175347
Befort CA, VanWormer JJ, Desouza C, Ellerbeck EF, Gajewski B, Kimminau KS, Greiner KA, Perri MG, Brown AR, Pathak RD, Huang TT, Eiland L, Drincic A. Effect of Behavioral Therapy With In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss Among Patients With Obesity in Rural Clinical Practice: A Randomized Clinical Trial. JAMA. 2021 Jan 26;325(4):363-372. doi: 10.1001/jama.2020.25855.
PubMed 33496775
Befort CA, Kurz D, VanWormer JJ, Ellerbeck EF. Recruitment and reach in a pragmatic behavioral weight loss randomized controlled trial: implications for real-world primary care practice. BMC Fam Pract. 2020 Mar 3;21(1):47. doi: 10.1186/s12875-020-01117-w.
PubMed 32126987

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER)
ClinicalTrials.gov ID: NCT02456636
Acronym / sponsor ID: RE-POWER / RE-POWER
Conditions: Obesity
Keywords: Weight loss, Weight management, Diabetes, Heart disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,432 participants (actual)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 15 Feb 2016 (actual)
Primary completion: 30 Dec 2019 (actual)
Study completion: 30 Dec 2019 (actual)
First posted: 28 May 2015 (estimated)
Results: Posted 29 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Individual weight-management counseling in person (in clinic individual visits)
Group weight-management counseling, both in person and by telephone; the latter if preferred by the group (in clinic group visits)
Group weight-management counseling by telephone (phone group visits)

Participants will be in the study about 24 months. The number of in-person clinic visits and phone calls each participant will be asked to complete depends on the method.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Fee-for-Service Model (FFS, In clinic individual visits)	Active comparator	Behavioral: Fee-for-Service Model (FFS, In clinic individual visits)Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.
Patient Centered Medical Home (PCMH, In clinic group visits)	Active comparator	Behavioral: Patient Centered Medical Home (PCMH, In clinic group visits)Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers.
Disease Management (DM, Phone group visits)	Active comparator	Behavioral: Disease Management (DM, Phone group visits)Participants will take part in group weight-management counseling by telephone.

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

BMI between 30 kg/m2 and 45 kg/m2.
Live in a rural location.
Have clearance from their primary care provider to participate in a diet and exercise weight control intervention.
Have access to a telephone.
One individual per household will be permitted to enroll in the study.

Key exclusion criteria (9 listed)

History of heart attack in the last six months, stroke in the last six months, or new cancer diagnosis in the last six months.
History of bariatric surgery or planning bariatric surgery in the next two years.
Pregnancy within the last six months or planned within the next two years or currently pregnant or lactating.
Serious medical conditions where weight loss is contraindicated.
End stage renal disease or end stage liver disease.

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
Fee-for-Service Model (FFS, In clinic individual visits)Also: Individual weight management counselingTo be performed by participant's doctor or other healthcare professional in their doctor's office.	Behavioural	Fee-for-Service Model (FFS, In clinic individual visits)
Patient Centered Medical Home (PCMH, In clinic group visits)Also: Group weight management counseling (in-person and telephone)To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.	Behavioural	Patient Centered Medical Home (PCMH, In clinic group visits)
Disease Management (DM, Phone group visits)Also: Group weight management counseling (telephone)To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.	Behavioural	Disease Management (DM, Phone group visits)

Primary outcome

Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation
Time frame: Baseline and 6, 18 and 24 months
Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.
Mean Weight Change Over 24 Months; Adjusted
Time frame: Baseline and 6, 18 and 24 months
Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Adjusted for affiliation, sex, race/ethnicity, education, diabetes, cardiovascular disease, and travel time to clinic.

13 secondary outcomes

Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation
Time frame: Baseline and 6, 18 and 24 months
Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation
Time frame: Baseline and 6, 18 and 24 months
Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation
Time frame: Baseline and 6, 18 and 24 months
Mean Change in Fasting Glucose; Unadjusted Except for Affiliation
Time frame: Baseline and 6 and 24 months
Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation
Time frame: Baseline and 6 and 24 months
Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation
Time frame: Baseline and 6 and 24 months
Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation
Time frame: Baseline and 6 and 24 months
Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation
Time frame: Baseline and 6 and 24 months
Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation
Time frame: Baseline and 6 and 24 months
Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation
Time frame: Baseline and 6 and 24 months
Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation
Time frame: Baseline and 6 and 24 months
Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation
Time frame: Baseline and 6 and 24 months
Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation
Time frame: Baseline and 6, 18 and 24 months

Results and safety

Results posted to the registry on 29 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fee-for-Service (In Clinic Individual Counseling)	478	410
Patient Centered Medical Home (In Clinic Group Counseling)	479	410
Disease Management (Phone Group Counseling)	475	400

Primary outcome: Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation

Time frame: Baseline and 6, 18 and 24 months. Mean (97.5% Confidence Interval). Unit: kg

Measure	Fee-for-Service (In Clinic Individual Counseling) n = 473	Patient Centered Medical Home (In Clinic Group Counseling) n = 468	Disease Management (Phone Group Counseling) n = 466
Mean Weight change at 6 months	-5.73 (-6.79 to -4.67)	-8.34 (-9.37 to -7.31)	-7.72 (-8.76 to -6.68)
Mean Weight change at 18 months	-3.35 (-4.57 to -2.14)	-5.58 (-6.77 to -4.39)	-5.17 (-6.37 to -3.97)
Mean Weight change at 24 months	-2.56 (-3.79 to -1.34)	-4.43 (-5.63 to -3.23)	-3.92 (-5.13 to -2.71)

Fee-for-Service (In Clinic Individual Counseling) vs Patient Centered Medical Home (In Clinic Group Counseling): Mean Difference (Net): -1.87 (97.5% CI -3.51 to -0.23), p = .025, Mixed Models Analysis
Fee-for-Service (In Clinic Individual Counseling) vs Disease Management (Phone Group Counseling): Mean Difference (Net): -1.36 (97.5% CI -3.00 to 0.29), p = 0.25, Mixed Models Analysis
Patient Centered Medical Home (In Clinic Group Counseling) vs Disease Management (Phone Group Counseling): Mean Difference (Net): -0.51 (97.5% CI -2.15 to 1.13), p = .025, Mixed Models Analysis

Population analysed: Enrolled minus deaths and medical removals.

Primary outcome: Mean Weight Change Over 24 Months; Adjusted

Time frame: Baseline and 6, 18 and 24 months. Mean (97.5% Confidence Interval). Unit: kg

Measure	Fee-for-Service (In Clinic Individual Counseling) n = 473	Patient Centered Medical Home (In Clinic Group Counseling) n = 468	Disease Management (Phone Group Counseling) n = 466
Mean weight change at 6 months	-6.01 (-7.72 to -4.31)	-8.62 (-10.23 to -7.00)	-7.97 (-9.63 to -6.32)
Mean weight change at 18 months	-3.65 (-5.46 to -1.83)	-5.84 (-7.57 to -4.12)	-5.44 (-7.20 to -3.68)
Mean weight change at 24 months	-2.85 (-4.67 to -1.03)	-4.69 (-6.42 to -2.96)	-4.19 (-5.96 to -2.42)

Fee-for-Service (In Clinic Individual Counseling) vs Patient Centered Medical Home (In Clinic Group Counseling): Median Difference (Net): -1.84 (97.5% CI -3.50 to -0.18), p = .025, Mixed Models Analysis
Fee-for-Service (In Clinic Individual Counseling) vs Disease Management (Phone Group Counseling): Median Difference (Net): -1.34 (97.5% CI -2.99 to 0.32), p = .025, Mixed Models Analysis
Patient Centered Medical Home (In Clinic Group Counseling) vs Disease Management (Phone Group Counseling): Mean Difference (Net): -0.50 (97.5% CI -2.15 to 1.15), p = .025, Mixed Models Analysis

Population analysed: Enrolled minus deaths and medical removals.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fee-for-Service (FFS; In Clinic Individual Counseling)	94 of 478 (19.7%)	0 of 478 (0%)	0 of 478
Patient Centered Medical Home(PCMH;In Clinic Group Counseling)	88 of 479 (18.4%)	0 of 479 (0%)	3 of 479
Disease Management (DM; Phone Group Counseling)	82 of 475 (17.3%)	0 of 475 (0%)	0 of 475

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42420235Bernal J, Wick JA, Gajewski B, Greiner KA, Wu J, Befort C. Weight-Related Self-Esteem, Group Behavioral Therapy, and Weight Loss. Obesity (Silver Spring). 2026 Aug;34(8):1541-1544. doi: 10.1002/oby.70257. Epub 2026 Jul 8.
Derived from this study: PubMed 35398370Saint Onge JM, Fagan M, Befort CA. The association between the obesogenic environment and 6-month and 24-month weight change in a rural weight loss intervention trial in the United States. Prev Med. 2022 May;158:107040. doi: 10.1016/j.ypmed.2022.107040. Epub 2022 Apr 7.
Derived from this study: PubMed 35081912Tang F, Befort CA, Wick J, Gajewski BJ. Unifying the analysis of continuous and categorical measures of weight loss and incorporating group effect: a secondary re-analysis of a large cluster randomized clinical trial using Bayesian approach. BMC Med Res Methodol. 2022 Jan 26;22(1):28. doi: 10.1186/s12874-021-01499-0.
Derived from this study: PubMed 34714976Katzmarzyk PT, Apolzan JW, Gajewski B, Johnson WD, Martin CK, Newton RL Jr, Perri MG, VanWormer JJ, Befort CA. Weight loss in primary care: A pooled analysis of two pragmatic cluster-randomized trials. Obesity (Silver Spring). 2021 Dec;29(12):2044-2054. doi: 10.1002/oby.23292. Epub 2021 Oct 29.
Derived from this study: PubMed 34175347Goessl CL, VanWormer JJ, Pathak RD, Ellerbeck EF, Befort CA. Affective disorders, weight change, and patient engagement in a rural behavioral weight loss trial. Prev Med. 2021 Nov;152(Pt 2):106698. doi: 10.1016/j.ypmed.2021.106698. Epub 2021 Jun 24.
Derived from this study: PubMed 33496775Befort CA, VanWormer JJ, Desouza C, Ellerbeck EF, Gajewski B, Kimminau KS, Greiner KA, Perri MG, Brown AR, Pathak RD, Huang TT, Eiland L, Drincic A. Effect of Behavioral Therapy With In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss Among Patients With Obesity in Rural Clinical Practice: A Randomized Clinical Trial. JAMA. 2021 Jan 26;325(4):363-372. doi: 10.1001/jama.2020.25855.
Derived from this study: PubMed 32126987Befort CA, Kurz D, VanWormer JJ, Ellerbeck EF. Recruitment and reach in a pragmatic behavioral weight loss randomized controlled trial: implications for real-world primary care practice. BMC Fam Pract. 2020 Mar 3;21(1):47. doi: 10.1186/s12875-020-01117-w.

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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?

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 9 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 7 Dec 2020. 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?

Yes. Results are posted in the registry (first posted 29 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation (time frame: Baseline and 6, 18 and 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02456636, which also lists 7 linked publications.

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 7 Dec 2020.