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Completed

NCT Number: NCT06284681

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

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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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Prehypertension Signs and Symptoms Type 2 Diabetes Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Recruitment rate

    Time frame: baseline

    Time required to meet recruitment goal

  2. Retention rate

    Time frame: week 26

    Number and proportion of participants completing the study

  3. Response/Non-response rate to initial interventions

    Time frame: week 8

    The proportion of participants meeting pre-specified response criteria initial interventions

  4. Attendance to health coaching sessions

    Time frame: week 26

    Number and proportion of health coaching sessions attended attendance

  5. Treatment Credibility and Expectancy Questionnaire (CEQ)

    Time frame: 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.

  6. Treatment Credibility and Expectancy Questionnaire (CEQ)

    Time frame: 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.

  7. Treatment Preference

    Time frame: baseline

    Measures the participant's preference for different treatments used in the study.

  8. Treatment Preference

    Time frame: week 8

    Measures the participant's preference for different treatments used in the study.

  9. Family medicine clinic capacity for research

    Time frame: week 26

    Measurement of family medicine clinic capacity for research

  10. Study visit duration

    Time frame: week 26

    Measurement of study visit duration

  11. Time required for surveys completion

    Time frame: week 26

    Measurement of time required for participants to complete the survey packet completion

  12. Response to weight-focused health coaching

    Time frame: 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.

  13. Response to weight-neutral health coaching measurement

    Time frame: 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 outcomes

  1. Change in blood pressure

    Time frame: Week 26

    Measured by mercury sphygmomanometer

  2. Change in glucose

    Time frame: Week 26

    Fasting blood draw

  3. Change in insulin

    Time frame: Week 26

    Fasting blood draw

  4. Change in insulin sensitivity

    Time frame: 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.

  5. Change in HbA1c

    Time frame: Week 26

    Fasting blood draw

  6. Change in total cholesterol

    Time frame: Week 26

    Fasting blood draw

  7. Change in LDL-cholesterol

    Time frame: Week 26

    Fasting blood draw

  8. Change in HDL-cholesterol

    Time frame: Week 26

    Fasting blood draw

  9. Change in triglycerides

    Time frame: Week 26

    Fasting blood draw

  10. Change in Metabolic Syndrome Severity Score

    Time frame: 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.

Other outcomes

  1. Change in blood pressure

    Time frame: Week 8

    Measured by mercury sphygmomanometer

  2. Change in glucose

    Time frame: Week 8

    Fasting blood draw

  3. Change in insulin

    Time frame: Week 8

    Fasting blood draw

  4. Change in HbA1c

    Time frame: Week 8

    Fasting blood draw

  5. Change in total cholesterol

    Time frame: Week 8

    Fasting blood draw

  6. Change in LDL-cholesterol

    Time frame: Week 8

    Fasting blood draw

  7. Change in HDL-cholesterol

    Time frame: Week 8

    Fasting blood draw

  8. Change in triglycerides

    Time frame: Week 8

    Fasting blood draw

  9. Change in body weight

    Time frame: Week 26

    Measured using family medicine clinic scale

  10. Change in physical activity

    Time frame: Week 26

    Measured accelerometry (activPAL 4)

  11. Change in fat mass

    Time frame: Week 8

    Measured by bioelectrical impedance (InBody S10)

  12. Change in fat mass

    Time frame: Week 26

    Measured by bioelectrical impedance (InBody S10)

  13. Change in lean mass

    Time frame: Week 8

    Measured by bioelectrical impedance (InBody S10)

  14. Change in lean mass

    Time frame: Week 26

    Measured by bioelectrical impedance (InBody S10)

  15. Change in waist circumference

    Time frame: Week 8

    Measured by Gulick tape

  16. Change in waist circumference

    Time frame: Week 26

    Measured by Gulick tape

  17. Dietary intake measurement

    Time frame: Week 8

    Measured by 7-day food record on ASA24

  18. Dietary intake measurement

    Time frame: Week 26

    Measured by 7-day food record on ASA24

  19. Change in insulin sensitivity

    Time frame: Week 8

    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.

  20. Change in Metabolic Syndrome Severity Score

    Time frame: Week 8

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study 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

Acronym: WISE Health

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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