Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults

Obesity Clinical Trial

— WISE Health  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension
• Obesity
• PreDiabetes
• Prehypertension
• Type 2 Diabetes

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