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| ID | Type | Description | Link |
|---|---|---|---|
| 3P50MD017338-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders | Active Comparator | 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. |
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| Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders | Active Comparator | 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. |
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| Weight-Focused Health Coaching with Enhanced Medical Management | Active Comparator | 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 | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight-focused health coaching | Behavioral | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Measured by mercury sphygmomanometer | Week 26 |
| Change in glucose | Fasting blood draw | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Measured by mercury sphygmomanometer | Week 8 |
| Change in glucose | Fasting blood draw | Week 8 |
Inclusion Criteria:
Black or African American Race
≥18 years
BMI ≥27 kg/m2 plus a diagnostic history of 1 or more of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Drew Sayer, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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.
Study-related data and supporting information will be made freely-available on PubMed Central following publication.
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| Weight-Focused Health Coaching Only | Active Comparator | This arm includes participants who responded to Weight-Focused Health Coaching in stage 1. |
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| Weight-Neutral Health Coaching Only | Active Comparator | This arm includes participants who responded to Weight-Neutral Health Coaching in stage 1. |
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| Weight-neutral health coaching | Behavioral | 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. |
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| Intensify lifestyle approach | Behavioral | 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. |
|
| Augment with enhanced medical management | Other | 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. |
|
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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D058246 | Prehypertension |
| D006973 | Hypertension |
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
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