Trial Outcomes & Findings for Health-Smart for Weight Loss at UF Jax Clinics (NCT NCT03418701)
NCT ID: NCT03418701
Last Updated: 2024-10-17
Results Overview
percentage of participating patients who show clinically significant weight loss (i.e., at least 5% of baseline body weight)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
683 participants
Primary outcome timeframe
6 months
Results posted on
2024-10-17
Participant Flow
A multifaceted approach was used to recruit Black women patients with obesity from the participating primary care centers. Recruitment included distribution of marketing materials in the clinic waiting rooms and exam rooms. Providers also discussed the trial with potentially eligible patients if they had an appointment during the recruitment period. If a patient showed interest in participating, she was to complete a form allowing a study team member to contact her about the trial.
A research coordinator performed a screening interview after receiving verbal consent from the caller. If the caller met the screening criteria and wants to participate in the study, a visit with their physician was scheduled to ensure that there were no medical contraindications to participation. This screening visit included a review of the patient's medications, medical history and physical exam. At the end of the screening visit, patients were informed whether they qualified for the study.
Unit of analysis: clinics
Participant milestones
| Measure |
Phase 1: 6-month CHW-implemented HSWL Program
All participants started in the HSWL program where they went to CHW led sessions that occurred weekly for 3 months then biweekly for 3 months. . During these sessions, the participants viewed and discussed segments of an HSWL Program DVD that shows culturally diverse families and community members, physicians, and other health care providers discussing health-smart behaviors and real-world strategies for engaging in these behaviors. The participants were given an HSWL Program Resource Guide, which is a supplement to the DVD, that contains more detailed information about the discussed health-smart behaviors. These participants were asked to read short sections of this guide to prepare them for the next group discussion. An important aspect of the group sessions was that participants learned from and taught each other ways to consistently engage in health-smart behaviors, including ways to overcome barriers to these behaviors. The CHWs facilitated these discussions called attention to relevant information in the DVD and resource guide only when needed.
|
Phase 2: Patient Centered Culturally Sensitive WLM
This program is designed to enable physicians to: (a) talk with their patients about their weight, weight loss goals, goal barriers, strategies for overcoming barriers, and talk in patient-centered, culturally sensitive ways, (b) assist patients with engaging in self-identified strategies for achieving and sustaining their goals for weight loss and overall health, (c) be knowledgeable about health-smart behaviors, (d) use behaviors and display attitudes in physician-patient interactions that are provider cultural sensitivity indicators and (e) say and display behaviors/attitudes that patients identified as important when discussing obesity and losing weight.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
Phase 2:Standard Behavioral WLM
This program is designed to enable physicians to: (a) implement motivational interviewing approaches with their patients about their weight loss goals and behavioral strategies to achieve these goals, (b) become knowledgeable about behavioral change principles that have been used to help patients maintain weight loss, (c) communicate how to use these behavioral change principles to have patients initiate or maintain their health-smart goals related to weight loss and/or weight loss maintenance, and (d) use motivational interviewing approaches to communicate empathy with patients who are struggling to maintain their weight loss and/or accomplish a behavioral goal.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
|---|---|---|---|
|
Phase 1: 6-mo CHW-implemented HSWL Progr
STARTED
|
683 20
|
0 0
|
0 0
|
|
Phase 1: 6-mo CHW-implemented HSWL Progr
COMPLETED
|
356 20
|
0 0
|
0 0
|
|
Phase 1: 6-mo CHW-implemented HSWL Progr
NOT COMPLETED
|
327 0
|
0 0
|
0 0
|
|
Phase 2: 12-mo Weight Loss Maintenance
STARTED
|
0 0
|
183 10
|
173 10
|
|
Phase 2: 12-mo Weight Loss Maintenance
COMPLETED
|
0 0
|
140 10
|
131 10
|
|
Phase 2: 12-mo Weight Loss Maintenance
NOT COMPLETED
|
0 0
|
43 0
|
42 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Health-Smart for Weight Loss at UF Jax Clinics
Baseline characteristics by cohort
| Measure |
Patient Centered Culturally Sensitive WLM
n=351 Participants
This program is designed to enable physicians to: (a) talk with their patients about their weight, weight loss goals, goal barriers, strategies for overcoming barriers, and talk in patient-centered, culturally sensitive ways, (b) assist patients with engaging in self-identified strategies for achieving and sustaining their goals for weight loss and overall health, (c) be knowledgeable about health-smart behaviors, (d) use behaviors and display attitudes in physician-patient interactions that are provider cultural sensitivity indicators and (e) say and display behaviors/attitudes that patients identified as important when discussing obesity and losing weight.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
Standard Behavioral WLM
n=332 Participants
This program is designed to enable physicians to: (a) implement motivational interviewing approaches with their patients about their weight loss goals and behavioral strategies to achieve these goals, (b) become knowledgeable about behavioral change principles that have been used to help patients maintain weight loss, (c) communicate how to use these behavioral change principles to have patients initiate or maintain their health-smart goals related to weight loss and/or weight loss maintenance, and (d) use motivational interviewing approaches to communicate empathy with patients who are struggling to maintain their weight loss and/or accomplish a behavioral goal.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
Total
n=683 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.46 Years
STANDARD_DEVIATION 12.32 • n=5 Participants
|
51.52 Years
STANDARD_DEVIATION 12.06 • n=7 Participants
|
52.04 Years
STANDARD_DEVIATION 12.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
351 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
683 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
351 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
683 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
351 participants
n=5 Participants
|
332 participants
n=7 Participants
|
683 participants
n=5 Participants
|
|
Weight
|
235.8 pounds
STANDARD_DEVIATION 47.8 • n=5 Participants
|
242.3 pounds
STANDARD_DEVIATION 52.1 • n=7 Participants
|
240 pounds
STANDARD_DEVIATION 51.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: In order to determine the significance of the proportion of participants who achieved 5% weight loss from baseline to 6 months, a confidence interval of the proportion was used. A dichotomized dependent variable was used where 0 indicated that the participant did not achieve 5% or more weight loss and 1 indicated that the participant achieved 5% or more. No covariates were used.
percentage of participating patients who show clinically significant weight loss (i.e., at least 5% of baseline body weight)
Outcome measures
| Measure |
6-month CHW-implemented HSWL Program
n=356 Participants
This program is designed to enable physicians to: (a) talk with their patients about their weight, weight loss goals, goal barriers, strategies for overcoming barriers, and talk in patient-centered, culturally sensitive ways, (b) assist patients with engaging in self-identified strategies for achieving and sustaining their goals for weight loss and overall health, (c) be knowledgeable about health-smart behaviors, (d) use behaviors and display attitudes in physician-patient interactions that are provider cultural sensitivity indicators and (e) say and display behaviors/attitudes that patients identified as important when discussing obesity and losing weight.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
Standard Behavioral WLM
This program is designed to enable physicians to: (a) implement motivational interviewing approaches with their patients about their weight loss goals and behavioral strategies to achieve these goals, (b) become knowledgeable about behavioral change principles that have been used to help patients maintain weight loss, (c) communicate how to use these behavioral change principles to have patients initiate or maintain their health-smart goals related to weight loss and/or weight loss maintenance, and (d) use motivational interviewing approaches to communicate empathy with patients who are struggling to maintain their weight loss and/or accomplish a behavioral goal.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
|---|---|---|
|
Weight Loss
|
24.04 percent who lost 5% or more weight
Interval 19.3 to 29.4
|
—
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Main analysis was a multilevel logistic regression with participants nested within clinic. A dichotomized dependent variable was used where 0 indicated that the participant gained more than 1 pound between 6 and 18 months (i.e., did not maintain weight loss) and 1 indicated that the participant gained less than 1 pound or continued to lose weight between 6 and 18 months (i.e., maintained weight loss). The independent variable was weight loss maintenance group. No covariates were used.
percentage of participants will maintain initial weight loss or show continued weight loss
Outcome measures
| Measure |
6-month CHW-implemented HSWL Program
n=140 Participants
This program is designed to enable physicians to: (a) talk with their patients about their weight, weight loss goals, goal barriers, strategies for overcoming barriers, and talk in patient-centered, culturally sensitive ways, (b) assist patients with engaging in self-identified strategies for achieving and sustaining their goals for weight loss and overall health, (c) be knowledgeable about health-smart behaviors, (d) use behaviors and display attitudes in physician-patient interactions that are provider cultural sensitivity indicators and (e) say and display behaviors/attitudes that patients identified as important when discussing obesity and losing weight.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
Standard Behavioral WLM
n=131 Participants
This program is designed to enable physicians to: (a) implement motivational interviewing approaches with their patients about their weight loss goals and behavioral strategies to achieve these goals, (b) become knowledgeable about behavioral change principles that have been used to help patients maintain weight loss, (c) communicate how to use these behavioral change principles to have patients initiate or maintain their health-smart goals related to weight loss and/or weight loss maintenance, and (d) use motivational interviewing approaches to communicate empathy with patients who are struggling to maintain their weight loss and/or accomplish a behavioral goal.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
|---|---|---|
|
Weight Loss Maintenance
|
34.63 percentage of participants
Interval 25.8 to 44.2
|
29.48 percentage of participants
Interval 21.9 to 37.5
|
Adverse Events
6-month CHW-implemented HSWL Program
Serious events: 5 serious events
Other events: 3 other events
Deaths: 1 deaths
Patient Centered Culturally Sensitive WLM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Standard Behavioral WLM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
6-month CHW-implemented HSWL Program
n=683 participants at risk
All participants started in the HSWL program where they went to CHW led sessions that occurred weekly for 3 months then biweekly for 3 months. . During these sessions, the participants viewed and discussed segments of an HSWL Program DVD that shows culturally diverse families and community members, physicians, and other health care providers discussing health-smart behaviors and real-world strategies for engaging in these behaviors. The participants were given an HSWL Program Resource Guide, which is a supplement to the DVD, that contains more detailed information about the discussed health-smart behaviors. These participants were asked to read short sections of this guide to prepare them for the next group discussion. An important aspect of the group sessions was that participants learned from and taught each other ways to consistently engage in health-smart behaviors, including ways to overcome barriers to these behaviors. The CHWs facilitated these discussions called attention to relevant information in the DVD and resource guide only when needed.
|
Patient Centered Culturally Sensitive WLM
n=183 participants at risk
This program is designed to enable physicians to: (a) talk with their patients about their weight, weight loss goals, goal barriers, strategies for overcoming barriers, and talk in patient-centered, culturally sensitive ways, (b) assist patients with engaging in self-identified strategies for achieving and sustaining their goals for weight loss and overall health, (c) be knowledgeable about health-smart behaviors, (d) use behaviors and display attitudes in physician-patient interactions that are provider cultural sensitivity indicators and (e) say and display behaviors/attitudes that patients identified as important when discussing obesity and losing weight.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
Standard Behavioral WLM
n=173 participants at risk
This program is designed to enable physicians to: (a) implement motivational interviewing approaches with their patients about their weight loss goals and behavioral strategies to achieve these goals, (b) become knowledgeable about behavioral change principles that have been used to help patients maintain weight loss, (c) communicate how to use these behavioral change principles to have patients initiate or maintain their health-smart goals related to weight loss and/or weight loss maintenance, and (d) use motivational interviewing approaches to communicate empathy with patients who are struggling to maintain their weight loss and/or accomplish a behavioral goal.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
back surgery
|
0.15%
1/683 • Number of events 1 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/183 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/173 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
knee arthroplasty
|
0.15%
1/683 • Number of events 1 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/183 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/173 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
ankle fracture
|
0.15%
1/683 • Number of events 1 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/183 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/173 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
|
Hepatobiliary disorders
nephrostolithotomy surgery
|
0.15%
1/683 • Number of events 1 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/183 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/173 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
|
Cardiac disorders
chest pain
|
0.15%
1/683 • Number of events 1 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/183 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/173 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
Other adverse events
| Measure |
6-month CHW-implemented HSWL Program
n=683 participants at risk
All participants started in the HSWL program where they went to CHW led sessions that occurred weekly for 3 months then biweekly for 3 months. . During these sessions, the participants viewed and discussed segments of an HSWL Program DVD that shows culturally diverse families and community members, physicians, and other health care providers discussing health-smart behaviors and real-world strategies for engaging in these behaviors. The participants were given an HSWL Program Resource Guide, which is a supplement to the DVD, that contains more detailed information about the discussed health-smart behaviors. These participants were asked to read short sections of this guide to prepare them for the next group discussion. An important aspect of the group sessions was that participants learned from and taught each other ways to consistently engage in health-smart behaviors, including ways to overcome barriers to these behaviors. The CHWs facilitated these discussions called attention to relevant information in the DVD and resource guide only when needed.
|
Patient Centered Culturally Sensitive WLM
n=183 participants at risk
This program is designed to enable physicians to: (a) talk with their patients about their weight, weight loss goals, goal barriers, strategies for overcoming barriers, and talk in patient-centered, culturally sensitive ways, (b) assist patients with engaging in self-identified strategies for achieving and sustaining their goals for weight loss and overall health, (c) be knowledgeable about health-smart behaviors, (d) use behaviors and display attitudes in physician-patient interactions that are provider cultural sensitivity indicators and (e) say and display behaviors/attitudes that patients identified as important when discussing obesity and losing weight.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
Standard Behavioral WLM
n=173 participants at risk
This program is designed to enable physicians to: (a) implement motivational interviewing approaches with their patients about their weight loss goals and behavioral strategies to achieve these goals, (b) become knowledgeable about behavioral change principles that have been used to help patients maintain weight loss, (c) communicate how to use these behavioral change principles to have patients initiate or maintain their health-smart goals related to weight loss and/or weight loss maintenance, and (d) use motivational interviewing approaches to communicate empathy with patients who are struggling to maintain their weight loss and/or accomplish a behavioral goal.
Health Smart for Weight Loss: We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
motor vehicle accident with minor injuries
|
0.15%
1/683 • Number of events 1 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/183 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/173 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
|
Injury, poisoning and procedural complications
Fell in store parking lot
|
0.15%
1/683 • Number of events 1 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/183 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/173 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
|
Infections and infestations
cyst drainage
|
0.15%
1/683 • Number of events 1 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/183 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
0.00%
0/173 • 24 months
Adverse events were reported to the community health workers during the Health-Smart weekly sessions in Phase 1 and then to physicians in Phase 2. Adverse events were considered serious if they resulted in hospitalizations.
|
Additional Information
Dr. Lori Bilello, Project Manager
University of Florida
Phone: 904-244-9202
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place