Health-Smart for Weight Loss at UF Jax Clinics

NCT ID: NCT03418701

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 683 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2022-07-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 these barriers, and deliver this talk in patient-centered, culturally sensitive ways, (b) assist their patients with engaging in self-identified strategies for achieving and sustaining their self selected goals for weight loss and overall health, (c) be knowledgeable about health-smart behaviors, (d) use behaviors and display attitudes in physician-patient interactions with patients that are provider cultural sensitivity indicators in published literature, and (e) say and display behaviors and attitudes that patients identified as important when discussing obesity and losing weight.

Group Type: ACTIVE_COMPARATOR

Health Smart for Weight Loss

Intervention Type: BEHAVIORAL

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 when talking with their patients about their weight loss goals and behavioral strategies to achieve these goals, (b) become knowledgeable about empirically supported behavioral change principles that have been used to help patients maintain weight loss in previous interventions, (c) communicate how to use these empirically supported behavioral change principles to have patients initiate or maintain their self-selected health-smart goals related to weight loss and/or weight loss maintenance, and (d) use motivational interviewing approaches to communicate empathy and understanding with patients who are struggling to maintain their weight loss and/or accomplish a behavioral goal.

Group Type: ACTIVE_COMPARATOR

Health Smart for Weight Loss

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolyn Tucker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health Jacksonville Primary Care network

Jacksonville, Florida, United States

Countries

United States

References

Tucker CM, Anton SD, Wippold GM, Marsiske M, Bilello LA, Henry MA, Shah NR, Gautam SP, Klein KG, Mathews A, Webb F, Desmond F. Promoting weight-loss maintenance among Black women primary care patients: A cluster RCT of a culturally sensitive versus standard behavioural approach. Clin Obes. 2022 Dec;12(6):e12553. doi: 10.1111/cob.12553. Epub 2022 Sep 23.

Reference Type: RESULT

PMID: 36151609 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AD-1609-36187

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB201703386

Identifier Type: -

Identifier Source: org_study_id