Using the Sequential Multiple Assignment Randomized Trial Experimental Approach to Develop an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Family medicine clinician referral rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Diet Counseling
Delivery of nutrition counseling intervention to improve diet quality.
干预措施: Diet Counseling (Behavioral)
Exercise Counseling
Delivery of exercise counseling intervention to increase engagement in physical activity..
干预措施: Exercise Counseling (Behavioral)
结局指标
主要结局
Family medicine clinician referral rates
时间窗: Month 6
Number of counseling sessions attended
时间窗: Month 6
Attendance to Zoom meetings
Frequency of metformin adherence (as applicable)
时间窗: Month 6
Number of times metformin was taken as prescribed
Treatment credibility
时间窗: 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.")
Rates of recruitment and retention
时间窗: Month 6
Number of participants recruited and retained in intervention
Intervention preference
时间窗: 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.
Rates of recruitment and retention
时间窗: Baseline
Number of participants recruited and retained in intervention
Rates of recruitment and retention
时间窗: Month 2
Number of participants recruited and retained in intervention
Family medicine clinician referral rates
时间窗: Baseline
Family medicine clinician referral rates
时间窗: Month 2
Number of counseling sessions attended
时间窗: Month 2
Attendance to Zoom meetings
Frequency of metformin adherence (as applicable)
时间窗: Month 2
Number of times metformin was taken as prescribed
Intervention preference
时间窗: 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
时间窗: 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.
Treatment credibility
时间窗: 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
时间窗: 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.")
次要结局
- Changes in glucose(Baseline to Months 2 and 6)
- Changes in body weight(Baseline to Months 2 and 6)
- Changes in glycosylated hemoglobin (hemoglobin A1C)(Baseline to Months 2 and 6)
- Changes in body composition (fat and lean mass)(Baseline to Months 2 and 6)
- Changes in insulin(Baseline to Months 2 and 6)
- Changes in lipids(Baseline to Months 2 and 6)
研究者
Drew Sayer
Primary Investigator
University of Alabama at Birmingham