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

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

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).

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; PreDiabetes; Prehypertension; Type 2 Diabetes; Dyslipidemia
• Intervention / Treatment: Behavioral: Weight-focused health coaching; Behavioral: Intensify lifestyle approach; Behavioral: Weight-neutral health coaching; Other: Augment with enhanced medical management

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.
Active Comparator: 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: 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.; 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.
Active Comparator: 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.
Active Comparator: 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.
Active Comparator: Weight-Focused Health Coaching Only; This arm includes participants who responded to Weight-Focused Health Coaching in stage 1.	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.
Active Comparator: Weight-Neutral Health Coaching Only; This arm includes participants who responded to Weight-Neutral Health Coaching in stage 1.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Time required to meet recruitment goal	baseline
Retention rate	Number and proportion of participants completing the study	week 26
Response/Non-response rate to initial interventions	The proportion of participants meeting pre-specified response criteria initial interventions	week 8
Attendance to health coaching sessions	Number and proportion of health coaching sessions attended attendance	week 26
Treatment Credibility and Expectancy Questionnaire (CEQ)	The CEQ measures how much the participant believes in the rationale for the study treatments and how much they expect the treatments to improve their health.	baseline
Treatment Credibility and Expectancy Questionnaire (CEQ)	The CEQ measures how much the participant believes in the rationale for the study treatments and how much they expect the treatments to improve their health.	week 8
Treatment Preference	Measures the participant's preference for different treatments used in the study.	baseline
Treatment Preference	Measures the participant's preference for different treatments used in the study.	week 8
Family medicine clinic capacity for research	Measurement of family medicine clinic capacity for research	week 26
Study visit duration	Measurement of study visit duration	week 26
Time required for surveys completion	Measurement of time required for participants to complete the survey packet completion	week 26
Response to weight-focused health coaching	Weight loss measured using family medicine clinic. scale. Greater than or equal to 3 percent weight loss is the threshold for "response" for the weight focused condition.	Week 8
Response to weight-neutral health coaching measurement	Physical activity measured accelerometry (activPAL4). Greater than or equal to 150 weekly minutes of physical activity is the threshold for response for the weight-neutral condition.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Measured by mercury sphygmomanometer	Week 26
Change in glucose	Fasting blood draw	Week 26
Change in insulin	Fasting blood draw	Week 26
Change in insulin sensitivity	Measured by the quantitative insulin sensitivity check index (QUICKI). QUICKI is derived from measures of fasting insulin and fasting glucose, and a QUICKI score below 0.357 indicates low insulin sensitivity.	Week 26
Change in HbA1c	Fasting blood draw	Week 26
Change in total cholesterol	Fasting blood draw	Week 26
Change in LDL-cholesterol	Fasting blood draw	Week 26
Change in HDL-cholesterol	Fasting blood draw	Week 26
Change in triglycerides	Fasting blood draw	Week 26
Change in Metabolic Syndrome Severity Score	Metabolic Syndrome Severity Scores below zero indicate a lower degree of metabolic syndrome compared to the average adult, scores near zero indicate an average degree of metabolic syndrome, and scores above zero indicate an above average degree of metabolic syndrome and future disease risk.	Week 26

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Measured by mercury sphygmomanometer	Week 8
Change in glucose	Fasting blood draw	Week 8
Change in insulin	Fasting blood draw	Week 8
Change in HbA1c	Fasting blood draw	Week 8
Change in total cholesterol	Fasting blood draw	Week 8
Change in LDL-cholesterol	Fasting blood draw	Week 8
Change in HDL-cholesterol	Fasting blood draw	Week 8
Change in triglycerides	Fasting blood draw	Week 8
Change in body weight	Measured using family medicine clinic scale	Week 26
Change in physical activity	Measured accelerometry (activPAL 4)	Week 26
Change in fat mass	Measured by bioelectrical impedance (InBody S10)	Week 8
Change in fat mass	Measured by bioelectrical impedance (InBody S10)	Week 26
Change in lean mass	Measured by bioelectrical impedance (InBody S10)	Week 8
Change in lean mass	Measured by bioelectrical impedance (InBody S10)	Week 26
Change in waist circumference	Measured by Gulick tape	Week 8
Change in waist circumference	Measured by Gulick tape	Week 26
Dietary intake measurement	Measured by 7-day food record on ASA24	Week 8
Dietary intake measurement	Measured by 7-day food record on ASA24	Week 26
Change in insulin sensitivity	Measured by the quantitative insulin sensitivity check index (QUICKI). QUICKI is derived from measures of fasting insulin and fasting glucose, and a QUICKI score below 0.357 indicates low insulin sensitivity.	Week 8
Change in Metabolic Syndrome Severity Score	Metabolic Syndrome Severity Scores below zero indicate a lower degree of metabolic syndrome compared to the average adult, scores near zero indicate an average degree of metabolic syndrome, and scores above zero indicate an above average degree of metabolic syndrome and future disease risk.	Week 8

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Drew Sayer, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): January 31, 2026
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Hypertension; Diabetes Mellitus, Type 2; Dyslipidemias; Prediabetic State; Prehypertension
• Other Study ID Numbers: IRB-300012557; 3P50MD017338-03S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Coded and cleaned scientific data - with all participant identifiers removed - from all time points and supporting information will be preserved and shared from resulting publication(s) to allow for validation and replication of the study. All participant identifying information (e.g., names, addresses, contact information) will be saved in a separate and secure file for future contact purposes via IRB-approved study personnel and protocols only. Study-related data will be available via PubMed Central following publication.
• IPD Sharing Time Frame: Study-related data and supporting information will be made freely-available on PubMed Central following publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No