Insulin ResistanceNCT04392284
Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
A study testing Diet Counseling and Exercise Counseling in people with Insulin Resistance and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to investigate the feasibility of conducting a multicomponent lifestyle intervention research study within the UAB Family Medicine Clinic at Highlands and to obtain preliminary data on the effectiveness of the adaptive treatment strategies being investigated to produce improvements in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insulin Resistance, Obesity, Diabetes
- What is being tested?
- Diet Counseling and Exercise Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 3 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Any race or ethnicity
- BMI >27 kg/m2
- Presence of 1 or more mild-to-moderate obesity-associated metabolic complications (i.e., Stage 1 Obesity)
- Prediabetes, type 2 diabetes (see exclusion criteria for additional details), metabolic syndrome, dyslipidemia, hypertension, non-alcoholic fatty liver disease
- Stable medication type and dosage for ≥3 months
Who cannot join
- If type 2 diabetes,
- Currently prescribed metformin or prescribed within previous 3 months
- HbA1c concentration of >12%
- Using exogenous insulin
- Pregnant or lactating within the past 6 months or trying to become pregnant
- Prescription for weight loss medications within the past 3 months
Show all 10Show fewer
- Severe obesity-related complications that require immediate and more intensive clinical therapy (e.g., pharmacotherapy and/or bariatric surgery) as determined by study physician and/or referring practitioner at UAB Family Medicine Clinic.
- History of kidney disease that may increase the risk of lactic acidosis with metformin.
- Currently prescribed the following medications that may increase the risk of lactic acidosis with metformin: acetazolamide (Diamox), dichlorphenamide (Keveyis), methazolamide, topiramate (Topamax, in Qsymia), or zonisamide (Zonegran).
- Does not have a life-sustaining medical implant such as a pacemaker.
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Highlands Family and Community Medicine Clinic
Birmingham, Alabama, 35205
About this study
Official title: Using the Sequential Multiple Assignment Randomized Trial Experimental Approach to Develop an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
The purpose of this study is to investigate the feasibility of conducting a multicomponent lifestyle intervention research study within the UAB Family Medicine Clinic at Highlands and to obtain preliminary data on the effectiveness of the adaptive treatment strategies being investigated to produce improvements in insulin resistance. This study is a Sequential Multiple Assignment Randomized Trial (SMART) with initial randomization groups of individualized nutrition counseling vs. individualized exercise counseling. Note that these initial nutrition or exercise interventions are NOT intended to produce significant weight loss. Participants that do not sufficiently improve their insulin resistance score after 8 weeks will be re-randomized to 2nd stage interventions of either receiving dietary counseling for weight loss or receiving a prescription for metformin. We will collect data on the effectiveness of the intervention to improve insulin resistance/metabolic health in the family medicine clinic as well as potential predictors or moderators of treatment success.
- Conditions
- Insulin Resistance, Obesity, Diabetes, Hypertension, Dyslipidemias, Metabolic Syndrome
- Being tested
- Diet Counseling, Exercise Counseling
- Keywords
- insulin resistance
- Medical subject headings
- Insulin Resistance, Obesity, Diabetes Mellitus, Hypertension, Dyslipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet CounselingBehavioural
Delivery of nutrition counseling intervention to improve diet quality. Suggested energy intake will be prescribed with the intent to maintain energy balance and current body weight. A total of 16 nutrition counseling sessions lasting ~30 minutes will be scheduled with a frequency of 1 session per week for 1 month (5 sessions), 1 session every-other week for months 2-6 (11 sessions). "Responding" participants who have improved their insulin resistance as measured at the 8-week visit will continue receiving this level of nutrition counseling through the end of the study, meeting with the dietitian every other week. Starting at week 9, those identified as "non-responding" participants will be re-randomized to 2nd stage interventions, of either receiving nutrition counseling for weight loss (meeting with the dietitian every other week) or the addition of a prescription for metformin.
Exercise CounselingBehavioural
Delivery of exercise counseling intervention to increase engagement in physical activity. The exercise specialist will counsel participants to progressively increase their weekly physical activity. Weight loss is not a primary goal of these exercise counseling sessions. A total of 16 exercise counseling sessions lasting ~30 minutes will be scheduled with a frequency of 1 session per week for 1 month (5 sessions), 1 session every-other week for months 2-6 (11 sessions). "Responding" participants who have improved their insulin resistance as measured at the 8-week visit will continue receiving this level of exercise counseling through the end of the study, meeting with the exercise specialist every other week. Starting at week 9, those identified as "non-responders" will be re-randomized to 2nd stage interventions, of either receiving nutrition counseling for weight loss (meeting with the dietitian every other week) or the addition of a prescription for metformin.
| Study group | Role | What they receive |
|---|---|---|
| Diet Counseling | Experimental | Delivery of nutrition counseling intervention to improve diet quality. Receives: Behavioral: Diet Counseling |
| Exercise Counseling | Experimental | Delivery of exercise counseling intervention to increase engagement in physical activity.. Receives: Behavioral: Exercise Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of recruitment and retention
Number of participants recruited and retained in intervention
Measured: Baseline
Rates of recruitment and retention
Number of participants recruited and retained in intervention
Measured: Month 2
Rates of recruitment and retention
Number of participants recruited and retained in intervention
Measured: Month 6
Family medicine clinician referral rates
Measured: Baseline
Family medicine clinician referral rates
Measured: Month 2
Family medicine clinician referral rates
Measured: Month 6
Number of counseling sessions attended
Attendance to Zoom meetings
Measured: Month 2
Number of counseling sessions attended
Attendance to Zoom meetings
Measured: Month 6
Frequency of metformin adherence (as applicable)
Number of times metformin was taken as prescribed
Measured: Month 2
Frequency of metformin adherence (as applicable)
Number of times metformin was taken as prescribed
Measured: Month 6
Intervention preference
Preference is determined by the Intervention Preference Questionnaire, using a 5-point Likert Scale for preference among study treatment arms. Scale includes options for "strong," "slight," or "no" preference for a given treatment component.
Measured: Baseline
Intervention preference
Preference is determined by the Intervention Preference Questionnaire, using a 5-point Likert Scale for preference among study treatment arms. Scale includes options for "strong," "slight," or "no" preference for a given treatment component.
Measured: Month 2
Intervention preference
Preference is determined by the Intervention Preference Questionnaire, using a 5-point Likert Scale for preference among study treatment arms. Scale includes options for "strong," "slight," or "no" preference for a given treatment component.
Measured: Month 6
Treatment credibility
Assessment of participants' perception of treatment success using the Credibility/Expectancy Questionnaire with a 9-point Likert scale, ranging from "not at all" (1) to "very" (9) for several descriptors (e.g., "useful," "logical.")
Measured: Baseline
Treatment credibility
Assessment of participants' perception of treatment success using the Credibility/Expectancy Questionnaire with a 9-point Likert scale, ranging from "not at all" (1) to "very" (9) for several descriptors (e.g., "useful," "logical.")
Measured: Month 2
Treatment credibility
Assessment of participants' perception of treatment success using the Credibility/Expectancy Questionnaire with a 9-point Likert scale, ranging from "not at all" (1) to "very" (9) for several descriptors (e.g., "useful," "logical.")
Measured: Month 6
Secondary outcomes (6)
Changes in body weight
Measured: Baseline to Months 2 and 6
Changes in body composition (fat and lean mass)
Fat mass and lean mass via bioelectrical impedance analysis
Measured: Baseline to Months 2 and 6
Changes in glucose
Serum glucose will be measured in a fasted state
Measured: Baseline to Months 2 and 6
Changes in insulin
Serum insulin will be measured in a fasted state
Measured: Baseline to Months 2 and 6
Changes in glycosylated hemoglobin (hemoglobin A1C)
Percentage (%) glycated hemoglobin as a measure of long-term blood glucose control
Measured: Baseline to Months 2 and 6
Changes in lipids
Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
Measured: Baseline to Months 2 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start19 Apr 2021
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Drew Sayer, University of Alabama at Birmingham
- Investigators
- Drew Sayer, PhD, Principal investigator, University of Alabama at BirminghamTapan Mehta, PhD, Principal investigator, University of Alabama at BirminghamGareth Dutton, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392284
- Sponsor's protocol ID
- IRB-300005391
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Sequential Multiple Assignment Randomized Trial Experimental Approach to Develop an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
- ClinicalTrials.gov ID
- NCT04392284
- Acronym / sponsor ID
- IRB-300005391
- Conditions
- Insulin Resistance, Obesity, Diabetes, Hypertension, Dyslipidemias, Metabolic Syndrome
- Keywords
- insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the feasibility of conducting a multicomponent lifestyle intervention research study within the UAB Family Medicine Clinic at Highlands and to obtain preliminary data on the effectiveness of the adaptive treatment strategies being investigated to produce improvements in insulin resistance. This study is a Sequential Multiple Assignment Randomized Trial (SMART) with initial randomization groups of individualized nutrition counseling vs. individualized exercise counseling. Note that these initial nutrition or exercise interventions are NOT intended to produce significant weight loss. Participants that do not sufficiently improve their insulin resistance score after 8 weeks will be re-randomized to 2nd stage interventions of either receiving dietary counseling for weight loss or receiving a prescription for metformin. We will collect data on the effectiveness of the intervention to improve insulin resistance/metabolic health in the family medicine clinic as well as potential predictors or moderators of treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Diet Counseling | Experimental | Behavioral: Diet CounselingDelivery of nutrition counseling intervention to improve diet quality. |
| Exercise Counseling | Experimental | Behavioral: Exercise CounselingDelivery of exercise counseling intervention to increase engagement in physical activity.. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Any race or ethnicity
- BMI >27 kg/m2
- Presence of 1 or more mild-to-moderate obesity-associated metabolic complications (i.e., Stage 1 Obesity)
- Prediabetes, type 2 diabetes (see exclusion criteria for additional details), metabolic syndrome, dyslipidemia, hypertension, non-alcoholic fatty liver disease
Key exclusion criteria (10 listed)
- If type 2 diabetes,
- Currently prescribed metformin or prescribed within previous 3 months
- HbA1c concentration of >12%
- Using exogenous insulin
- Pregnant or lactating within the past 6 months or trying to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet CounselingDelivery of nutrition counseling intervention to improve diet quality. Suggested energy intake will be prescribed with the intent to maintain energy balance and current body weight. A total of 16 nutrition counseling sessions lasting ~30 minutes will be scheduled with a frequency of 1 session per week for 1 month (5 sessions), 1 session every-other week for months 2-6 (11 sessions). "Responding" participants who have improved their insulin resistance as measured at the 8-week visit will continue receiving this level of nutrition counseling through the end of the study, meeting with the dietitian every other week. Starting at week 9, those identified as "non-responding" participants will be re-randomized to 2nd stage interventions, of either receiving nutrition counseling for weight loss (meeting with the dietitian every other week) or the addition of a prescription for metformin. | Behavioural | Diet Counseling |
| Exercise CounselingDelivery of exercise counseling intervention to increase engagement in physical activity. The exercise specialist will counsel participants to progressively increase their weekly physical activity. Weight loss is not a primary goal of these exercise counseling sessions. A total of 16 exercise counseling sessions lasting ~30 minutes will be scheduled with a frequency of 1 session per week for 1 month (5 sessions), 1 session every-other week for months 2-6 (11 sessions). "Responding" participants who have improved their insulin resistance as measured at the 8-week visit will continue receiving this level of exercise counseling through the end of the study, meeting with the exercise specialist every other week. Starting at week 9, those identified as "non-responders" will be re-randomized to 2nd stage interventions, of either receiving nutrition counseling for weight loss (meeting with the dietitian every other week) or the addition of a prescription for metformin. | Behavioural | Exercise Counseling |
Primary outcome
Rates of recruitment and retention
Time frame: Baseline
Number of participants recruited and retained in intervention
Rates of recruitment and retention
Time frame: Month 2
Number of participants recruited and retained in intervention
Rates of recruitment and retention
Time frame: Month 6
Number of participants recruited and retained in intervention
Family medicine clinician referral rates
Time frame: Baseline
Family medicine clinician referral rates
Time frame: Month 2
Family medicine clinician referral rates
Time frame: Month 6
Number of counseling sessions attended
Time frame: Month 2
Attendance to Zoom meetings
Number of counseling sessions attended
Time frame: Month 6
Attendance to Zoom meetings
Frequency of metformin adherence (as applicable)
Time frame: Month 2
Number of times metformin was taken as prescribed
Frequency of metformin adherence (as applicable)
Time frame: Month 6
Number of times metformin was taken as prescribed
Intervention preference
Time frame: Baseline
Preference is determined by the Intervention Preference Questionnaire, using a 5-point Likert Scale for preference among study treatment arms. Scale includes options for "strong," "slight," or "no" preference for a given treatment component.
Intervention preference
Time frame: Month 2
Preference is determined by the Intervention Preference Questionnaire, using a 5-point Likert Scale for preference among study treatment arms. Scale includes options for "strong," "slight," or "no" preference for a given treatment component.
Intervention preference
Time frame: Month 6
Preference is determined by the Intervention Preference Questionnaire, using a 5-point Likert Scale for preference among study treatment arms. Scale includes options for "strong," "slight," or "no" preference for a given treatment component.
Treatment credibility
Time frame: Baseline
Assessment of participants' perception of treatment success using the Credibility/Expectancy Questionnaire with a 9-point Likert scale, ranging from "not at all" (1) to "very" (9) for several descriptors (e.g., "useful," "logical.")
Treatment credibility
Time frame: Month 2
Assessment of participants' perception of treatment success using the Credibility/Expectancy Questionnaire with a 9-point Likert scale, ranging from "not at all" (1) to "very" (9) for several descriptors (e.g., "useful," "logical.")
Treatment credibility
Time frame: Month 6
Assessment of participants' perception of treatment success using the Credibility/Expectancy Questionnaire with a 9-point Likert scale, ranging from "not at all" (1) to "very" (9) for several descriptors (e.g., "useful," "logical.")
6 secondary outcomes
Changes in body weight
Time frame: Baseline to Months 2 and 6
Changes in body composition (fat and lean mass)
Time frame: Baseline to Months 2 and 6
Changes in glucose
Time frame: Baseline to Months 2 and 6
Changes in insulin
Time frame: Baseline to Months 2 and 6
Changes in glycosylated hemoglobin (hemoglobin A1C)
Time frame: Baseline to Months 2 and 6
Changes in lipids
Time frame: Baseline to Months 2 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drew Sayer, PhD principal investigator
University of Alabama at Birmingham
Tapan Mehta, PhD principal investigator
University of Alabama at Birmingham
Gareth Dutton, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Counseling and Exercise Counseling in people with Insulin Resistance and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of recruitment and retention (time frame: Baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.