Clinical trial NCT06284681: Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults
Official title: Weight-focused vs. Weight-neutral Adaptive Biobehavioral Strategies for Improving Metabolic Health in Black Adults With Stage 1 Obesity: A Pilot Sequential Multiple Assignment Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Prehypertension
Hypertension
PreDiabetes
Type 2 Diabetes
Dyslipidemia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-02-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: baseline
measure: Retention rate
timeFrame: week 26
measure: Response/Non-response rate to initial interventions
timeFrame: week 8
measure: Attendance to health coaching sessions
timeFrame: week 26
measure: Treatment Credibility and Expectancy Questionnaire (CEQ)
timeFrame: baseline
measure: Treatment Credibility and Expectancy Questionnaire (CEQ)
timeFrame: week 8
measure: Treatment Preference
timeFrame: baseline
measure: Treatment Preference
timeFrame: week 8
measure: Family medicine clinic capacity for research
timeFrame: week 26
measure: Study visit duration
timeFrame: week 26
measure: Time required for surveys completion
timeFrame: week 26
measure: Response to weight-focused health coaching
timeFrame: Week 8
measure: Response to weight-neutral health coaching measurement
timeFrame: Week 8
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Week 26
measure: Change in glucose
timeFrame: Week 26
measure: Change in insulin
timeFrame: Week 26
measure: Change in insulin sensitivity
timeFrame: Week 26
measure: Change in HbA1c
timeFrame: Week 26
measure: Change in total cholesterol
timeFrame: Week 26
measure: Change in LDL-cholesterol
timeFrame: Week 26
measure: Change in HDL-cholesterol
timeFrame: Week 26
measure: Change in triglycerides
timeFrame: Week 26
measure: Change in Metabolic Syndrome Severity Score
timeFrame: Week 26
Other outcomes:
measure: Change in blood pressure
timeFrame: Week 8
measure: Change in glucose
timeFrame: Week 8
measure: Change in insulin
timeFrame: Week 8
measure: Change in HbA1c
timeFrame: Week 8
measure: Change in total cholesterol
timeFrame: Week 8
measure: Change in LDL-cholesterol
timeFrame: Week 8
measure: Change in HDL-cholesterol
timeFrame: Week 8
measure: Change in triglycerides
timeFrame: Week 8
measure: Change in body weight
timeFrame: Week 26
measure: Change in physical activity
timeFrame: Week 26
measure: Change in fat mass
timeFrame: Week 8
measure: Change in fat mass
timeFrame: Week 26
measure: Change in lean mass
timeFrame: Week 8
measure: Change in lean mass
timeFrame: Week 26
measure: Change in waist circumference
timeFrame: Week 8
measure: Change in waist circumference
timeFrame: Week 26
measure: Dietary intake measurement
timeFrame: Week 8
measure: Dietary intake measurement
timeFrame: Week 26
measure: Change in insulin sensitivity
timeFrame: Week 8
measure: Change in Metabolic Syndrome Severity Score
timeFrame: Week 8
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Drew Sayer, PhD
role: PRINCIPAL_INVESTIGATOR
References: