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

Purpose

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).

Conditions

  • Obesity
  • Prehypertension
  • Hypertension
  • PreDiabetes
  • Type 2 Diabetes
  • Dyslipidemia

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders 		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.
  • Behavioral: Weight-focused health coaching
    Following the definition of structured lifestyle interventions within the current obesity clinical practice guidelines, the weight-focused health coaching intervention will be delivered as a multi-component behavior change intervention intended to produce clinically-important weight loss through consuming a healthy, energy-restricted diet and increasing physical activity.
  • Behavioral: Intensify lifestyle approach
    Participants identified as non-responders to initial health coaching interventions may be re-randomized to receive a 4-month membership to the local YMCA and health coaches will assist participants in identifying and enrolling in at least 2 weekly group fitness classes at the YMCA.
Experimental
Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders 		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.
  • Behavioral: Weight-neutral health coaching
    Dietary and physical activity prescriptions for the weight-neutral health coaching intervention will be similar to the weight-focused intervention except the diet prescription will be designed to fully meet daily estimated energy requirements rather than creating a negative energy balance and producing weight loss. Health coaches will not emphasize changes in body weight as an explicit goal or as a mediator of improved cardiometabolic health. Rather, health coaches will emphasize achieving diet and exercise behavioral goals as a direct means to improving cardiometabolic health independently of changes in body weight.
  • Behavioral: Intensify lifestyle approach
    Participants identified as non-responders to initial health coaching interventions may be re-randomized to receive a 4-month membership to the local YMCA and health coaches will assist participants in identifying and enrolling in at least 2 weekly group fitness classes at the YMCA.
Experimental
Weight-Focused Health Coaching with Enhanced Medical Management 		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.
  • Behavioral: Weight-focused health coaching
    Following the definition of structured lifestyle interventions within the current obesity clinical practice guidelines, the weight-focused health coaching intervention will be delivered as a multi-component behavior change intervention intended to produce clinically-important weight loss through consuming a healthy, energy-restricted diet and increasing physical activity.
  • Other: Augment with enhanced medical management
    Participants identified as non-responders to initial health coaching interventions may be re-randomized to meet with the primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions.
Experimental
Weight-Neutral Health Coaching with Enhanced Medical Management 		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.
  • Behavioral: Weight-neutral health coaching
    Dietary and physical activity prescriptions for the weight-neutral health coaching intervention will be similar to the weight-focused intervention except the diet prescription will be designed to fully meet daily estimated energy requirements rather than creating a negative energy balance and producing weight loss. Health coaches will not emphasize changes in body weight as an explicit goal or as a mediator of improved cardiometabolic health. Rather, health coaches will emphasize achieving diet and exercise behavioral goals as a direct means to improving cardiometabolic health independently of changes in body weight.
  • Other: Augment with enhanced medical management
    Participants identified as non-responders to initial health coaching interventions may be re-randomized to meet with the primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Drew Sayer, PhD
205-354-8950
sayerd@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Drew Sayer, PhD
(205) 354-8950
sayerd@uab.edu