Health-Smart for Weight Loss at UF Jax Clinics

Overview

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.

Full Title of Study: “Culturally Sensitive Primary Care Clinic-based Interventions by Community Health Workers and Trained Physicians to Promote and Sustain Weight Loss Among Obese Black Women Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Behavioral: 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).

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • weight loss
    • Time Frame: 6 months
    • percentage of participating patients who show clinically significant weight loss (i.e., at least 5% of baseline body weight)
  • weight loss maintenance
    • Time Frame: 18 months
    • percentage of participants will maintain initial weight loss or show continued weight loss

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Collaborator
    • Patient-Centered Outcomes Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carolyn Tucker, PhD, Principal Investigator, University of Florida

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