Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

Obesity Clinical Trial

Official title:

Using the Sequential Multiple Assignment Randomized Trial Experimental Approach to Develop an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392284
• Other study ID #: IRB-300005391
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: June 3, 2022

Study information

• Verified date: June 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Dyslipidemias
• Hypertension
• Insulin Resistance
• Metabolic Syndrome
• Obesity

Intervention

Behavioral:
• Diet Counseling
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 Counseling
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.

Locations

Country	Name	City	State
United States	UAB Highlands Family and Community Medicine Clinic	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of recruitment and retention	Number of participants recruited and retained in intervention	Baseline
Primary	Rates of recruitment and retention	Number of participants recruited and retained in intervention	Month 2
Primary	Rates of recruitment and retention	Number of participants recruited and retained in intervention	Month 6
Primary	Family medicine clinician referral rates		Baseline
Primary	Family medicine clinician referral rates		Month 2
Primary	Family medicine clinician referral rates		Month 6
Primary	Number of counseling sessions attended	Attendance to Zoom meetings	Month 2
Primary	Number of counseling sessions attended	Attendance to Zoom meetings	Month 6
Primary	Frequency of metformin adherence (as applicable)	Number of times metformin was taken as prescribed	Month 2
Primary	Frequency of metformin adherence (as applicable)	Number of times metformin was taken as prescribed	Month 6
Primary	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.	Baseline
Primary	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.	Month 2
Primary	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.	Month 6
Primary	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.")	Baseline
Primary	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.")	Month 2
Primary	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.")	Month 6
Secondary	Changes in body weight		Baseline to Months 2 and 6
Secondary	Changes in body composition (fat and lean mass)	Fat mass and lean mass via bioelectrical impedance analysis	Baseline to Months 2 and 6
Secondary	Changes in glucose	Serum glucose will be measured in a fasted state	Baseline to Months 2 and 6
Secondary	Changes in insulin	Serum insulin will be measured in a fasted state	Baseline to Months 2 and 6
Secondary	Changes in glycosylated hemoglobin (hemoglobin A1C)	Percentage (%) glycated hemoglobin as a measure of long-term blood glucose control	Baseline to Months 2 and 6
Secondary	Changes in lipids	Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides	Baseline to Months 2 and 6