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
2 other identifiers
interventional
41
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 29, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedFebruary 27, 2026
February 1, 2026
1.3 years
February 6, 2024
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (13)
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 Outcomes (10)
Change in blood pressure
Week 26
Change in glucose
Week 26
Change in insulin
Week 26
Change in insulin sensitivity
Week 26
Change in HbA1c
Week 26
- +5 more secondary outcomes
Other Outcomes (20)
Change in blood pressure
Week 8
Change in glucose
Week 8
Change in insulin
Week 8
- +17 more other outcomes
Study Arms (6)
Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders
ACTIVE COMPARATORParticipants 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.
Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders
ACTIVE COMPARATORParticipants 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.
Weight-Focused Health Coaching with Enhanced Medical Management
ACTIVE COMPARATORParticipants 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.
Weight-Neutral Health Coaching with Enhanced Medical Management
ACTIVE COMPARATORParticipants 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.
Weight-Focused Health Coaching Only
ACTIVE COMPARATORThis arm includes participants who responded to Weight-Focused Health Coaching in stage 1.
Weight-Neutral Health Coaching Only
ACTIVE COMPARATORThis arm includes participants who responded to Weight-Neutral Health Coaching in stage 1.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence of any condition precluding engagement in the prescribed diet or exercise interventions
- Currently engaged in a structured lifestyle-based or weight loss intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Drew Sayer, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 6, 2024
First Posted
February 29, 2024
Study Start
October 1, 2024
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Study-related data and supporting information will be made freely-available on PubMed Central following publication.
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.