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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06284681
Other study ID # IRB-300012557
Secondary ID 3P50MD017338-03S
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source University of Alabama at Birmingham
Contact Drew Sayer, PhD
Phone (205) 354-8950
Email sayerd@uab.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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.
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.
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham National Institute on Minority Health and Health Disparities (NIMHD)

Outcome

Type Measure Description Time frame Safety issue
Other Change in blood pressure Measured by mercury sphygmomanometer Week 8
Other Change in glucose Fasting blood draw Week 8
Other Change in insulin Fasting blood draw Week 8
Other Change in HbA1c Fasting blood draw Week 8
Other Change in total cholesterol Fasting blood draw Week 8
Other Change in LDL-cholesterol Fasting blood draw Week 8
Other Change in HDL-cholesterol Fasting blood draw Week 8
Other Change in triglycerides Fasting blood draw Week 8
Other Change in body weight Measured using family medicine clinic scale Week 26
Other Change in physical activity Measured accelerometry (activPAL 4) Week 26
Other Change in fat mass Measured by bioelectrical impedance (InBody S10) Week 8
Other Change in fat mass Measured by bioelectrical impedance (InBody S10) Week 26
Other Change in lean mass Measured by bioelectrical impedance (InBody S10) Week 8
Other Change in lean mass Measured by bioelectrical impedance (InBody S10) Week 26
Other Change in waist circumference Measured by Gulick tape Week 8
Other Change in waist circumference Measured by Gulick tape Week 26
Other Dietary intake measurement Measured by 7-day food record on ASA24 Week 8
Other Dietary intake measurement Measured by 7-day food record on ASA24 Week 26
Other 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
Other 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
Primary Recruitment rate Time required to meet recruitment goal baseline
Primary Retention rate Number and proportion of participants completing the study week 26
Primary Response/Non-response rate to initial interventions The proportion of participants meeting pre-specified response criteria initial interventions week 8
Primary Attendance to health coaching sessions Number and proportion of health coaching sessions attended attendance week 26
Primary 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
Primary 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
Primary Treatment Preference Measures the participant's preference for different treatments used in the study. baseline
Primary Treatment Preference Measures the participant's preference for different treatments used in the study. week 8
Primary Family medicine clinic capacity for research Measurement of family medicine clinic capacity for research week 26
Primary Study visit duration Measurement of study visit duration week 26
Primary Time required for surveys completion Measurement of time required for participants to complete the survey packet completion week 26
Primary 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
Primary 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 Change in blood pressure Measured by mercury sphygmomanometer Week 26
Secondary Change in glucose Fasting blood draw Week 26
Secondary Change in insulin Fasting blood draw Week 26
Secondary 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
Secondary Change in HbA1c Fasting blood draw Week 26
Secondary Change in total cholesterol Fasting blood draw Week 26
Secondary Change in LDL-cholesterol Fasting blood draw Week 26
Secondary Change in HDL-cholesterol Fasting blood draw Week 26
Secondary Change in triglycerides Fasting blood draw Week 26
Secondary 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
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