Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults
- Conditions
- HypertensionPrehypertensionType 2 DiabetesObesityPreDiabetesDyslipidemia
- Interventions
- Behavioral: Weight-neutral health coachingBehavioral: Weight-focused health coachingBehavioral: Intensify lifestyle approachOther: Augment with enhanced medical management
- Registration Number
- NCT06284681
- Lead Sponsor
- University of Alabama at Birmingham
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders Intensify lifestyle approach 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. Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders Intensify lifestyle approach 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. Weight-Neutral Health Coaching with Enhanced Medical Management Augment 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. Weight-Focused Health Coaching with Enhanced Medical Management Augment 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. Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders Weight-neutral health coaching 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. Weight-Focused Health Coaching with Enhanced Medical Management Weight-focused health coaching 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. Weight-Neutral Health Coaching with Enhanced Medical Management Weight-neutral health coaching 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. Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders Weight-focused health coaching 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.
- Primary Outcome Measures
Name Time Method Recruitment rate baseline Time required to meet recruitment goal
Study visit duration week 26 Measurement of study visit duration
Attendance to health coaching sessions week 26 Number and proportion of health coaching sessions attended attendance
Retention rate week 26 Number and proportion of participants completing the study
Treatment Preference week 8 Measures the participant's preference for different treatments used in the study.
Response to weight-neutral health coaching measurement Week 8 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.
Response/Non-response rate to initial interventions week 8 The proportion of participants meeting pre-specified response criteria initial interventions
Treatment Credibility and Expectancy Questionnaire (CEQ) week 8 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.
Family medicine clinic capacity for research week 26 Measurement of family medicine clinic capacity for research
Time required for surveys completion week 26 Measurement of time required for participants to complete the survey packet completion
Response to weight-focused health coaching Week 8 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.
- Secondary Outcome Measures
Name Time Method Change in insulin sensitivity Week 26 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.
Change in HbA1c Week 26 Fasting blood draw
Change in total cholesterol Week 26 Fasting blood draw
Change in HDL-cholesterol Week 26 Fasting blood draw
Change in Metabolic Syndrome Severity Score Week 26 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.
Change in glucose Week 26 Fasting blood draw
Change in triglycerides Week 26 Fasting blood draw
Change in blood pressure Week 26 Measured by mercury sphygmomanometer
Change in insulin Week 26 Fasting blood draw
Change in LDL-cholesterol Week 26 Fasting blood draw
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States