An interventional study of Weight-focused health coaching and Weight-neutral health coaching in Obesity, Prehypertension and Hypertension, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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).
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 41 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Black or African American Race
≥27 kg/m2 plus a diagnostic history of 1 or more of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Weight-focused health coaching · Behavioral: Intensify lifestyle approach
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.
Behavioral: Weight-neutral health coaching · Behavioral: Intensify lifestyle approach
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.
Behavioral: Weight-focused health coaching · Other: Augment with enhanced medical management
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.
Behavioral: Weight-neutral health coaching · Other: Augment with enhanced medical management
This arm includes participants who responded to Weight-Focused Health Coaching in stage 1.
Behavioral: Weight-focused health coaching
This arm includes participants who responded to Weight-Neutral Health Coaching in stage 1.
Behavioral: Weight-neutral 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.
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.
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.
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.
Recruitment rate
Time required to meet recruitment goal
Time frame: baseline
Retention rate
Number and proportion of participants completing the study
Time frame: week 26
Response/Non-response rate to initial interventions
The proportion of participants meeting pre-specified response criteria initial interventions
Time frame: week 8
Attendance to health coaching sessions
Number and proportion of health coaching sessions attended attendance
Time frame: 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.
Time frame: 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.
Time frame: week 8
Treatment Preference
Measures the participant's preference for different treatments used in the study.
Time frame: baseline
Treatment Preference
Measures the participant's preference for different treatments used in the study.
Time frame: week 8
Family medicine clinic capacity for research
Measurement of family medicine clinic capacity for research
Time frame: week 26
Study visit duration
Measurement of study visit duration
Time frame: week 26
Time required for surveys completion
Measurement of time required for participants to complete the survey packet completion
Time frame: 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.
Time frame: 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.
Time frame: Week 8
Change in blood pressure
Measured by mercury sphygmomanometer
Time frame: Week 26
Change in glucose
Fasting blood draw
Time frame: Week 26
Change in insulin
Fasting blood draw
Time frame: 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.
Time frame: Week 26
Change in HbA1c
Fasting blood draw
Time frame: Week 26
Change in total cholesterol
Fasting blood draw
Time frame: Week 26
Change in LDL-cholesterol
Fasting blood draw
Time frame: Week 26
Change in HDL-cholesterol
Fasting blood draw
Time frame: Week 26
Change in triglycerides
Fasting blood draw
Time frame: 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.
Time frame: Week 26
Change in blood pressure
Measured by mercury sphygmomanometer
Time frame: Week 8
Change in glucose
Fasting blood draw
Time frame: Week 8
Change in insulin
Fasting blood draw
Time frame: Week 8
Change in HbA1c
Fasting blood draw
Time frame: Week 8
Change in total cholesterol
Fasting blood draw
Time frame: Week 8
Change in LDL-cholesterol
Fasting blood draw
Time frame: Week 8
Change in HDL-cholesterol
Fasting blood draw
Time frame: Week 8
Change in triglycerides
Fasting blood draw
Time frame: Week 8
Change in body weight
Measured using family medicine clinic scale
Time frame: Week 26
Change in physical activity
Measured accelerometry (activPAL 4)
Time frame: Week 26
Change in fat mass
Measured by bioelectrical impedance (InBody S10)
Time frame: Week 8
Change in fat mass
Measured by bioelectrical impedance (InBody S10)
Time frame: Week 26
Change in lean mass
Measured by bioelectrical impedance (InBody S10)
Time frame: Week 8
Change in lean mass
Measured by bioelectrical impedance (InBody S10)
Time frame: Week 26
Change in waist circumference
Measured by Gulick tape
Time frame: Week 8
Change in waist circumference
Measured by Gulick tape
Time frame: Week 26
Dietary intake measurement
Measured by 7-day food record on ASA24
Time frame: Week 8
Dietary intake measurement
Measured by 7-day food record on ASA24
Time frame: 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.
Time frame: 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.
Time frame: Week 8
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Study-related data and supporting information will be made freely-available on PubMed Central following publication.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham →