Obesity
Conditions
Keywords
Women's health
Brief summary
The study will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program is being implemented by Community Health Workers at the primary care centers and followed by either of two physician-implemented behavioral counseling programs to prevent weight gain--programs that are implemented quarterly over 12 months.
Detailed description
Objectives: Aim 1 was to evaluate the effectiveness of the community health worker (CHW)-implemented, clinic-located, evidence-based, 6-month Health-Smart Weight Loss (HSWL) Program, as indicated by participants' mean weight loss. Aim 2 was to compare the outcomes of the following two 12-month, clinic-based weight loss maintenance programs implemented by patients' physicians after these patients completed the 6-month weight loss intervention: the physician-implemented Patient-Centered, Culturally Sensitive Weight Loss Maintenance (PCCS-WLM) intervention, and the Standard Behavioral Weight Loss Maintenance (SB-WLM) intervention. These two weight loss maintenance interventions differ in that the physicians who implemented the PCCS-WLM intervention were trained to display patient-identified, culturally sensitive behaviors and attitudes when talking with patients about their weight and to support patients' engagement in health promoting (health-smart) behaviors in order to promote patients' weight loss maintenance, whereas physicians in the SB-WLM intervention were trained to use behavioral change principles and skills as well as motivational interviewing approaches to behavior change in order to promote patients' weight loss maintenance. Aim 3 was to implement and evaluate a medical assistant-led program to integrate CHWs into health care teams. Methods: Participants were recruited from 21 primary care practices operated by an academic medical center. Participants' eligibility criteria were: Black women ages 21 years or older with a BMI of 30 kg/m2 or higher who had at least 2 clinic visits in the previous 24 months and were ready to change their diet and physical activity level. All participants received the 6-month CHW-implemented HSWL Program to address Aim 1. Therefore, results from baseline to 6 months are presented as one group. The study was constructed as a cluster-randomized trial to address Aim 2; thus, after the HSWL Program involving all participants was completed, clinics were randomized to the either the SB-WLM group or the PCCS-WLM group. Consequently, results after 6 months are presented separately for the two groups. Clinics were randomized with patients nested within clinic. To address Aim 1, a paired samples t-test and confidence interval of the proportion of the sample that achieved 5% or more weight loss by 6 months were used. To address Aim 2, a logistic regression with participants nested within clinics and Aim 2 study group as the independent variable was used. To address Aim 3, which was to evaluate integration of CHWs into the health care team, a virtual meeting was held with the CHWs who remained at the end of the study (n=8) for the purpose of asking exploratory semi-structured questions about the clinical staff behaviors that helped them feel or not feel integrated into the clinical team and to identify what would improve and/or sustain integration of CHWs into the clinical team. Content analysis using the constant comparison method was applied to the responses of the CHWs to the semi-structured questions asked. The communications and follow-through subscale of the TeamSTEPPS Assessment Tool was used to assess communication among the clinic staff as viewed by the participating clinic staff as a group and CHWs as a group. Mean ratings of responses to this subscale for each of these groups were calculated.
Interventions
BEHAVIORALHealth 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).
Sponsors
Patient-Centered Outcomes Research Institute
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* African American/black * Female * Age 21 years or older * BMI range ≥ 30kg/m2 (5) active patient of a participating clinic (i.e., at least 2 clinic visits in the last 24 months) * Willing and ready to change one's diet and physical activity level * Willing to be randomized to either of the two weight-loss maintenance intervention groups
Exclusion criteria
* Any serious medical condition that likely affects weight, such as end stage renal disease or cancer * Prior bariatric surgery within the last 5 years or plans for this surgery in the next 2 years * Use of prescription or over-the-counter weight-loss medication within the last 6 months * Pregnant or plan to get pregnant within the next 2 years * Plan to relocate from the area within the next 2 years * Having had unintentional weight loss (\>or = to 5% of body weight) within 6 months prior to enrollment * Taking a daily dose of oral corticosteroid antipsychotic (clozapine, olanzapine, or risperidone) for less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 6 months | percentage of participating patients who show clinically significant weight loss (i.e., at least 5% of baseline body weight) |
| Weight Loss Maintenance | 18 months | percentage of participants will maintain initial weight loss or show continued weight loss |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 351 |
| 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). | 332 |
| Total | 683 |
Baseline characteristics
| Characteristic | Patient Centered Culturally Sensitive WLM | Standard Behavioral WLM | Total |
|---|---|---|---|
| Age, Continuous | 52.46 Years STANDARD_DEVIATION 12.32 | 51.52 Years STANDARD_DEVIATION 12.06 | 52.04 Years STANDARD_DEVIATION 12.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 351 Participants | 332 Participants | 683 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 351 participants | 332 participants | 683 participants |
| Sex: Female, Male Female | 351 Participants | 332 Participants | 683 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 235.8 pounds STANDARD_DEVIATION 47.8 | 242.3 pounds STANDARD_DEVIATION 52.1 | 240 pounds STANDARD_DEVIATION 51.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 683 | 2 / 183 | 2 / 173 |
| other Total, other adverse events | 3 / 683 | 0 / 183 | 0 / 173 |
| serious Total, serious adverse events | 5 / 683 | 0 / 183 | 0 / 173 |
Outcome results
Primary
Weight Loss
percentage of participating patients who show clinically significant weight loss (i.e., at least 5% of baseline body weight)
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6-month CHW-implemented HSWL Program | Weight Loss | 24.04 percent who lost 5% or more weight |
p-value: <0.0595% CI: [0.93, 4.4]t-test, 2 sided
Primary
Weight Loss Maintenance
percentage of participants will maintain initial weight loss or show continued weight loss
Time frame: 18 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6-month CHW-implemented HSWL Program | Weight Loss Maintenance | 34.63 percentage of participants |
| Standard Behavioral WLM | Weight Loss Maintenance | 29.48 percentage of participants |
p-value: <0.0595% CI: [0.22, 1.15]Mixed Models Analysis