Health-Smart for Weight Loss at UF Jax Clinics

NCT03418701 | Completed Results DMC

• 2 other identifiers: IRB201703386AD-1609-36187
• Study Type: interventional
• Target: 683
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Women's health

Outcome Measures

Primary Outcomes (2)

• Weight Loss

  percentage of participating patients who show clinically significant weight loss (i.e., at least 5% of baseline body weight)

  6 months

• Weight Loss Maintenance

  percentage of participants will maintain initial weight loss or show continued weight loss

  18 months

Study Arms (2)

Patient Centered Culturally Sensitive WLM

ACTIVE COMPARATOR

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

Standard Behavioral WLM

ACTIVE COMPARATOR

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

Interventions

Health Smart for Weight Loss BEHAVIORAL

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).

Patient Centered Culturally Sensitive WLM; Standard Behavioral WLM

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

UF Health Jacksonville Primary Care network

Jacksonville, Florida, 32209, United States

Location

Related 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 standard behavioural approach. Clin Obes. 2022 Dec;12(6):e12553. doi: 10.1111/cob.12553. Epub 2022 Sep 23.

  PMID: 36151609 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Since the intervention delivered as part of Aim 1 was an uncontrolled pre-post study, we cannot determine whether or not the HSWL intervention caused the weight loss observed among our study participants during the first six months, as there was not a control/comparison group. Another limitation is that of the 683 Black women who enrolled and provided baseline data, only 63.9% actually participated in the study intervention (i.e., attended any of the interventions sessions in the study).

Results Point of Contact

• Title: Dr. Lori Bilello, Project Manager
• Organization: University of Florida

Lori.bilello@jax.ufl.edu

904-244-9202

Study Officials

• Carolyn Tucker, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 1, 2018
• Study Start: April 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: July 31, 2022
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Locations

US (1)