Dyslipidemia, Hypertension, Obesity, PreDiabetes, Prehypertension, Type 2 Diabetes
Conditions
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).
Interventions
BEHAVIORALWeight-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.
BEHAVIORALWeight-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.
BEHAVIORALIntensify 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.
OTHERAugment 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.
Sponsors
University of Alabama at Birmingham
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | baseline | Time required to meet recruitment goal |
| Retention rate | week 26 | Number and proportion of participants completing the study |
| Response/Non-response rate to initial interventions | week 8 | The proportion of participants meeting pre-specified response criteria initial interventions |
| Attendance to health coaching sessions | week 26 | Number and proportion of health coaching sessions attended attendance |
| Treatment Credibility and Expectancy Questionnaire (CEQ) | baseline | 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. |
| Treatment Preference | baseline | Measures the participant's preference for different treatments used in the study. |
| Family medicine clinic capacity for research | week 26 | Measurement of family medicine clinic capacity for research |
| Study visit duration | week 26 | Measurement of study visit duration |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | Week 26 | Measured by mercury sphygmomanometer |
| Change in glucose | Week 26 | Fasting blood draw |
| Change in insulin | Week 26 | Fasting blood draw |
| 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 LDL-cholesterol | Week 26 | Fasting blood draw |
| Change in HDL-cholesterol | Week 26 | Fasting blood draw |
| Change in triglycerides | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDrew Sayer, PhD
University of Alabama at Birmingham
Outcome results
None listed