Back to resultsDeveloping an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
Primary Purpose
Insulin Resistance, Obesity, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet Counseling
Exercise Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring insulin resistance
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- UAB Highlands Family and Community Medicine Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diet Counseling
Exercise Counseling
Arm Description
Delivery of nutrition counseling intervention to improve diet quality.
Delivery of exercise counseling intervention to increase engagement in physical activity..
Outcomes
Primary Outcome Measures
Rates of recruitment and retention
Number of participants recruited and retained in intervention
Rates of recruitment and retention
Number of participants recruited and retained in intervention
Rates of recruitment and retention
Number of participants recruited and retained in intervention
Family medicine clinician referral rates
Family medicine clinician referral rates
Family medicine clinician referral rates
Number of counseling sessions attended
Attendance to Zoom meetings
Number of counseling sessions attended
Attendance to Zoom meetings
Frequency of metformin adherence (as applicable)
Number of times metformin was taken as prescribed
Frequency of metformin adherence (as applicable)
Number of times metformin was taken as prescribed
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.
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.
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.
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.")
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.")
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.")
Secondary Outcome Measures
Changes in body weight
Changes in body composition (fat and lean mass)
Fat mass and lean mass via bioelectrical impedance analysis
Changes in glucose
Serum glucose will be measured in a fasted state
Changes in insulin
Serum insulin will be measured in a fasted state
Changes in glycosylated hemoglobin (hemoglobin A1C)
Percentage (%) glycated hemoglobin as a measure of long-term blood glucose control
Changes in lipids
Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
Full Information
NCT ID
NCT04392284
First Posted
April 19, 2020
Last Updated
June 27, 2022
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04392284
Brief Title
Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
Official Title
Using the Sequential Multiple Assignment Randomized Trial Experimental Approach to Develop an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
June 3, 2022 (Actual)
Study Completion Date
June 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity, Diabetes, Hypertension, Dyslipidemias, Metabolic Syndrome
Keywords
insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Sequential Multiple Assignment Randomized Trial (SMART)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet Counseling
Arm Type
Experimental
Arm Description
Delivery of nutrition counseling intervention to improve diet quality.
Arm Title
Exercise Counseling
Arm Type
Experimental
Arm Description
Delivery of exercise counseling intervention to increase engagement in physical activity..
Intervention Type
Behavioral
Intervention Name(s)
Diet Counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rates of recruitment and retention
Description
Number of participants recruited and retained in intervention
Time Frame
Baseline
Title
Rates of recruitment and retention
Description
Number of participants recruited and retained in intervention
Time Frame
Month 2
Title
Rates of recruitment and retention
Description
Number of participants recruited and retained in intervention
Time Frame
Month 6
Title
Family medicine clinician referral rates
Time Frame
Baseline
Title
Family medicine clinician referral rates
Time Frame
Month 2
Title
Family medicine clinician referral rates
Time Frame
Month 6
Title
Number of counseling sessions attended
Description
Attendance to Zoom meetings
Time Frame
Month 2
Title
Number of counseling sessions attended
Description
Attendance to Zoom meetings
Time Frame
Month 6
Title
Frequency of metformin adherence (as applicable)
Description
Number of times metformin was taken as prescribed
Time Frame
Month 2
Title
Frequency of metformin adherence (as applicable)
Description
Number of times metformin was taken as prescribed
Time Frame
Month 6
Title
Intervention preference
Description
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.
Time Frame
Baseline
Title
Intervention preference
Description
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.
Time Frame
Month 2
Title
Intervention preference
Description
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.
Time Frame
Month 6
Title
Treatment credibility
Description
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.")
Time Frame
Baseline
Title
Treatment credibility
Description
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.")
Time Frame
Month 2
Title
Treatment credibility
Description
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.")
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Changes in body weight
Time Frame
Baseline to Months 2 and 6
Title
Changes in body composition (fat and lean mass)
Description
Fat mass and lean mass via bioelectrical impedance analysis
Time Frame
Baseline to Months 2 and 6
Title
Changes in glucose
Description
Serum glucose will be measured in a fasted state
Time Frame
Baseline to Months 2 and 6
Title
Changes in insulin
Description
Serum insulin will be measured in a fasted state
Time Frame
Baseline to Months 2 and 6
Title
Changes in glycosylated hemoglobin (hemoglobin A1C)
Description
Percentage (%) glycated hemoglobin as a measure of long-term blood glucose control
Time Frame
Baseline to Months 2 and 6
Title
Changes in lipids
Description
Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
Time Frame
Baseline to Months 2 and 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drew Sayer, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tapan Mehta, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gareth Dutton, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Highlands Family and Community Medicine Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
We'll reach out to this number within 24 hrs