Health-Smart for Weight Loss at UF Jax Clinics

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418701
• Other study ID #: IRB201703386
• Secondary ID: AD-1609-36187
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 683
• Est. completion date: July 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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).

Locations

Country	Name	City	State
United States	UF Health Jacksonville Primary Care network	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 standa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	percentage of participating patients who show clinically significant weight loss (i.e., at least 5% of baseline body weight)	6 months
Primary	weight loss maintenance	percentage of participants will maintain initial weight loss or show continued weight loss	18 months