Health-Smart for Weight Loss at UF Jax Clinics

Not Applicable

Completed

Conditions: Obesity

Registration Number: NCT03418701

Lead Sponsor: University of Florida

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 683

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): UF Health Jacksonville Primary Care network
🇺🇸
Jacksonville, Florida, United States
UF Health Jacksonville Primary Care network
🇺🇸Jacksonville, Florida, United States