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Health-Smart for Weight Loss at UF Jax Clinics

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ClinicalTrials.gov Identifier: NCT03418701
Recruitment Status : Active, not recruiting
First Posted : February 1, 2018
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE January 25, 2018
First Posted Date  ICMJE February 1, 2018
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE April 1, 2018
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health-Smart for Weight Loss at UF Jax Clinics
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Health Smart for Weight Loss
  • 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.
    Intervention: Behavioral: Health Smart for Weight Loss
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 26, 2019)
683
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2018)
680
Estimated Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03418701
Other Study ID Numbers  ICMJE IRB201703386
AD-1609-36187 ( Other Grant/Funding Number: PATIENT-CENTERED OUTCOMES RES INST )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Carolyn Tucker, PhD University of Florida
PRS Account University of Florida
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP