Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults (WISE Health)

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Hypertension; Prehypertension; Obesity; Dyslipidemia; Type 2 Diabetes; PreDiabetes

Treatments: Other: Augment with enhanced medical management; Behavioral: Intensify lifestyle approach; Behavioral: Weight-neutral health coaching; Behavioral: Weight-focused health coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06284681

3P50MD017338-03S1 (U.S. NIH Grant/Contract)

IRB-300012557

Details and patient eligibility

About

The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity (BMI ≥27 kg/m2) plus at least one weight-related cardiometabolic condition (high blood pressure, prediabetes or diabetes, and/or high cholesterol). Biobehavioral interventions are treatment strategies that combine lifestyle-based behavioral interventions such as eating a healthy diet and exercise with medications. In this study, participants will be randomly assigned to receive either weight-focused or weight-neutral health coaching for 7 weeks. At week 8, participants will be identified as either "responders" or "nonresponders" to the initial interventions. The threshold for response in the weight-focused condition is greater than or equal to 3% weight loss. The threshold for response in the weight-neutral condition is engaging in greater than or equal to 150 minutes of moderate physical activity for the 7 days prior to the week 8 study visit. Responders to the initial interventions will continue with health coaching on a biweekly basis for weeks 9-26 of the intervention. Nonresponders will be re-randomized to either intensify the lifestyle-based intervention by receiving a membership to the YMCA and enrolling in group fitness classes or augmenting the health coaching with enhanced medical management in partnership with their established primary care provider. The second aim is to use clinical data from the pilot SMART to estimate treatment effects and the between-person variability in these effects. Because this is a pilot study, these estimates will not be used to make comparisons or draw conclusions on the comparative effectiveness of intervention conditions. Rather, these data will be used to generate preliminary effect sizes that can be used to estimate the sample size required for a full-scale trial. Clinical trial feasibility data will be collected on an ongoing basis throughout the study and clinical data will be collected prior to initiating the intervention (baseline) and at week 8 (response visit) and week 26 (post-intervention visit).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Black or African American Race

• ≥18 years

• BMI ≥27 kg/m2 plus a diagnostic history of 1 or more of the following:

  • Prehypertension or hypertension
  • Prediabetes or type 2 diabetes
  • Dyslipidemia

• Has a primary care provider who is willing to participate in enhanced medical management condition as needed

• Access and ability to use a device with reliable internet connectivity

• Able to converse and read English

• Willingness to enroll in any possible intervention conditions

• Willingness to engage in post-intervention focus group

Exclusion criteria

• Presence of any condition precluding engagement in the prescribed diet or exercise interventions
• Currently engaged in a structured lifestyle-based or weight loss intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

---

60 participants in 4 patient groups

Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders

Experimental group

Description:

Participants will start with weight-focused health coaching for 7 weeks and individuals achieving \<3% weight loss will be given a 4-month membership to the YMCA and enrolled in group fitness classes.

Treatment:

Behavioral: Weight-focused health coaching

Behavioral: Intensify lifestyle approach

Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders

Experimental group

Description:

Participants will start with weight-neutral health coaching for 7 weeks and individuals achieving \<150 minutes of moderate physical activity will be given a 4-month membership to the YMCA and enrolled in group fitness classes.

Treatment:

Behavioral: Weight-neutral health coaching

Behavioral: Intensify lifestyle approach

Weight-Focused Health Coaching with Enhanced Medical Management

Experimental group

Description:

Participants will start with weight-focused health coaching for 7 weeks and individuals achieving \<3% weight loss will meet with their primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions.

Treatment:

Behavioral: Weight-focused health coaching

Other: Augment with enhanced medical management

Weight-Neutral Health Coaching with Enhanced Medical Management

Experimental group

Description:

Participants will start with weight-neutral health coaching for 7 weeks and individuals achieving \<150 minutes of moderate physical activity will meet with their primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions.

Treatment:

Behavioral: Weight-neutral health coaching

Other: Augment with enhanced medical management