Lifestyle Change Implementation Research Network at PRC at UMass Chan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Primary Outcomes
研究概览
简要总结
The goal of this project is to study how well the Noom digital lifestyle program works for adults who are taking Glucagon-Like Peptide-1 receptor agonist (GLP-1) medications. The study team will assess how the program affects people's behaviors and health outcomes. The team will also look at how digital lifestyle change interventions can be implemented in real-world settings, including how many people it reaches, how well it is put into practice, whether people stick with it over time, and whether it works well for different groups of people.
详细描述
This study will examine how a digital lifestyle change program (Noom) may support adults who have recently started taking GLP-1 medications, which are commonly prescribed for weight loss and blood sugar control. The goal is to better understand how structured lifestyle guidance may improve physical activity, nutrition, and overall health while people are using these medications.
A total of 220 adults will participate in the study. Participants will be randomly assigned to one of two groups. One group will receive a four-month digital lifestyle coaching program designed to support healthy eating, physical activity, and strength-building habits. The other group will receive standard of care, a Fitbit device, resources for physical activity and nutrition, and the opportunity to participate in the lifestyle program at the completion of their 8-months in the study.
Participants will be assessed at the start of the study, after four months, and again at eight months. Throughout the study, the team will measure levels of physical activity using Fitbit devices. They will also evaluate overall diet quality using 24- hour dietary recalls of foods and beverages consumed. In addition, the team will examine other health and behavior measures, including intake of protein, fruits, and vegetables; participation in muscle-strengthening activities; confidence in maintaining healthy habits; muscle mass; body weight; waist circumference; and blood pressure.
In the 2nd Aim, the study team will evaluate implementation factors, such as how many participants were reached, how the program was implemented, engagement within the program, and how well how well the lifestyle coaching program can be delivered within real-world healthcare settings. Information will be gathered from patients, lifestyle change program leaders, healthcare providers, and healthcare systems. Data sources will include medical records, program records, and interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Began using a GLP-1 within the past 6 months
- •Currently using GLP-1
- •Plans to continue GLP-1 use
- •GLP-1 prescribed by their physician (e.g., not online or 3rd party vendor)
- •BMI ≥27 kg/m2
- •Age 18 years of age and older
- •Speaks and reads English or Spanish
- •Willing to enroll in a digital lifestyle intervention for 4-months
- •Willing to wear a Fitbit for 8 months
排除标准
- •Was taking a GLP-1 within the 2 months prior to the current GLP-1 start date
- •Currently participating in a structured lifestyle change program (receiving structured guidance and counseling on physical activity, diet or weight loss)
- •Currently pregnant
- •Planning to become pregnant in the next year
- •Active diagnosis of an eating disorder
研究组 & 干预措施
Standard Care
Participants in the standard of care arm will receive physical activity and nutrition resources, including those endorsed by the CDC and local resources within UMass Memorial Health and the surrounding communities, as well as Fitbit device. Upon completion of the 8-month study measures, participants will have the opportunity to participate in the 4-month digital LCI program, free of cost.
Digital Lifestyle Coaching Program
Participants randomized to the digital LCI arm will participate in a 4-month digital lifestyle intervention consisting of content modules about physical activity, nutrition, and GLP-1 support, nutrition and physical activity tracking, goal-setting, access to a health coach. They will receive a Fitbit and the same resources as the Standard of Care arm.
干预措施: Digital Lifestyle Coaching Program (Other)
结局指标
主要结局
Primary Outcomes
时间窗: Baseline, 4-, and 8-months
Minutes of moderate/vigorous PA per day (over 7 days) assessed via Fitbits on days the participant has sufficient wear time, defined as \>10 hours of heart rate data (accumulated of 60-second bouts).
Healthy Eating Index
时间窗: Baseline, 4, and 8 months
Healthy Eating Index will be assessed via two 24-hour dietary recalls at each timepoint. The Healthy Eating Index is scored on a scale 0-100, with higher scores indicating better diet quality and alignment with the Dietary Guidelines for Americans.
次要结局
- Physical Activity/Sedentary Time Metrics(Mean counts over 7-days at baseline, 4-, and 8-months.)
- Protein, Fruit, and Vegetable Intake(Baseline, 4-, and 8-months)
- Lean Body Mass(Baseline, 4-, and 8-months)
- Body Weight(Baseline, 4-, and 8-months)
- Blood Pressure(Baseline, 4-, and 8-months)
- Body Mass Index (BMI)(Baseline, 4-, and 8-months)
- Muscle Strengthening Activities(Baseline, 4-, and 8-months)
- Physical Activity Self-Efficacy(Baseline, 4-, and 8-months)
- Physical Activity Motivation(Baseline, 4-, and 8-months)
- Healthy Eating Self-Efficacy(Baseline, 4-, and 8-months)
- Healthy Eating Motivation(Baseline, 4-, and 8-months)
- Global Physical Health(Baseline, 4-, and 8-months)
- Intervention Acceptability(4-months in Intervention group only)
研究者
Jamie Faro
Assistant Professor
University of Massachusetts, Worcester