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Health-Smart for Weight Loss at UF Jax Clinics

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ClinicalTrials.gov Identifier: NCT03418701
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Health Smart for Weight Loss Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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).

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.
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).




Primary Outcome Measures :
  1. 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)

  2. weight loss maintenance [ Time Frame: 18 months ]
    percentage of participants will maintain initial weight loss or show continued weight loss



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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American/black
  • Female
  • Age 21 years or older
  • BMI range 30-50 kg/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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418701


Contacts
Contact: Carolyn Tucker, PhD 352-273-2167 cmtucker@ufl.edu
Contact: Lori Bilello, PhD 904-244-9202 lori.bilello@jax.ufl.edu

Locations
United States, Florida
UF Health Jacksonville Primary Care network Recruiting
Jacksonville, Florida, United States, 32209
Contact: Erica Guerrido, BS    904-244-9276    erica.guerrido@jax.ufl.edu   
Sponsors and Collaborators
University of Florida
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Carolyn Tucker, PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03418701     History of Changes
Other Study ID Numbers: IRB201703386
AD-1609-36187 ( Other Grant/Funding Number: PATIENT-CENTERED OUTCOMES RES INST )
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Women's health

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms