GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss: Does Developing Mastery Before Tracking Diet Enhance Engagement?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change in Weight
研究概览
简要总结
This study is a randomized controlled trial that compares 3 self-monitoring approaches for weight loss. GoalTracker is a standalone, technology-based intervention using a commercial smartphone app (MyFitnessPal) and email.
The investigators hypothesize that the group that delays diet tracking and receives additional intervention components (weekly personalized feedback, skills training, and action plans) will have greater weight loss at the end of the 12-week intervention and at 6-month followup, compared to (a) an intervention group that simultaneously tracks weight and diet for all 12 weeks and receives the same additional components, and (b) a control group that tracks only diet.
详细描述
This study will examine whether a digital health intervention (GoalTracker) can promote weight loss among adults who are overweight or obese. Engagement in self-monitoring often declines over time, which is then associated with suboptimal weight loss. Finding ways to improve self-monitoring engagement, particularly in the first month of treatment, is needed. Promoting mastery, self-efficacy, and self-regulatory skills may help with maintaining high engagement.
The investigators aim to enroll 105 participants. All groups are asked to self-monitor daily on their smartphone using the free commercial mobile application MyFitnessPal over the course of the 12-week intervention.
Specifically, the study aims to...
- Determine the effect of a Sequential self-monitoring intervention, compared to a Simultaneous self-monitoring intervention on weight change, caloric intake change, and proportion of individuals achieving 5% weight loss.
- Determine the effect of the Sequential self-monitoring intervention, compared to the Control, on the same variables.
- Compare self-monitoring engagement by intervention arm.
- Examine the relation between self-monitoring engagement and weight loss.
- Investigate theoretical mediators (self-efficacy, mastery, and self-regulation) on the relation between treatment arm and weight change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 21-65 years old
- •Body Mass Index (BMI) 25-45 kg/m2
- •interested in losing weight through dietary change
- •current use of iPhone or Android smartphone
- •current use of email address
- •has daily access to a bathroom scale
- •no recent weight loss (≥10 lbs) in the past 6 months
- •able to read and write in English
- •able to attend 3 in-person evaluation visits at Duke University in Durham, North Carolina over a 3-month period
排除标准
- •current participation in another weight loss treatment
- •currently pregnant or planning to become pregnant within study period, or < 1 year post-partum
- •history of cardiovascular event, eating disorder, diabetes mellitus, hypothyroidism, cancer, end stage renal disease
- •current uncontrolled hypertension
- •use of the MyFitnessPal app to track food in the past 6 months
- •Former or planned bariatric surgery
- •current use of medication (e.g., lithium, steroids, anti-psychotics)
- •use of weight loss medication in past 6 months
- •profound cognitive, developmental, or psychiatric disorders or recent hospitalization in a psychiatric facility
研究组 & 干预措施
Sequential Intervention
- in this Sequential eHealth intervention, participants are asked to self-monitor only their body weight for the first month, then for months 2 and 3 they will be asked to also self-monitor their diet
- participants are asked to use the MyFitnessPal app for self-monitoring
- given goal to lose 5% weight by end of intervention (3 months)
- weekly personalized feedback via email
- weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email
- weekly action plans via email
干预措施: self-monitoring of body weight (Behavioral)
Sequential Intervention
- in this Sequential eHealth intervention, participants are asked to self-monitor only their body weight for the first month, then for months 2 and 3 they will be asked to also self-monitor their diet
- participants are asked to use the MyFitnessPal app for self-monitoring
- given goal to lose 5% weight by end of intervention (3 months)
- weekly personalized feedback via email
- weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email
- weekly action plans via email
干预措施: self-monitoring of diet (Behavioral)
Sequential Intervention
- in this Sequential eHealth intervention, participants are asked to self-monitor only their body weight for the first month, then for months 2 and 3 they will be asked to also self-monitor their diet
- participants are asked to use the MyFitnessPal app for self-monitoring
- given goal to lose 5% weight by end of intervention (3 months)
- weekly personalized feedback via email
- weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email
- weekly action plans via email
干预措施: weekly personalized feedback + lessons + action plans (Behavioral)
Simultaneous Intervention
- in this Simultaneous eHealth intervention, participants are asked to self-monitor both their body weight and diet for 3 months
- participants are asked to use the MyFitnessPal app for self-monitoring
- given goal to lose 5% weight by end of intervention (3 months)
- weekly personalized feedback via email
- weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email
- weekly action plans via email
干预措施: self-monitoring of body weight (Behavioral)
Simultaneous Intervention
- in this Simultaneous eHealth intervention, participants are asked to self-monitor both their body weight and diet for 3 months
- participants are asked to use the MyFitnessPal app for self-monitoring
- given goal to lose 5% weight by end of intervention (3 months)
- weekly personalized feedback via email
- weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email
- weekly action plans via email
干预措施: self-monitoring of diet (Behavioral)
Simultaneous Intervention
- in this Simultaneous eHealth intervention, participants are asked to self-monitor both their body weight and diet for 3 months
- participants are asked to use the MyFitnessPal app for self-monitoring
- given goal to lose 5% weight by end of intervention (3 months)
- weekly personalized feedback via email
- weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email
- weekly action plans via email
干预措施: weekly personalized feedback + lessons + action plans (Behavioral)
Control (diet-tracking only)
- participants are asked to self-monitor their diet for 3 months
- participants are asked to use the MyFitnessPal app for self-monitoring
- given goal to lose 5% weight by end of intervention (3 months)
干预措施: self-monitoring of diet (Behavioral)
结局指标
主要结局
Change in Weight
时间窗: Baseline, 1 month, 3 months
Weight will be collected in kilograms using a calibrated digital scale
次要结局
- Change in Weight at 6 Months(6 months)
- Self-Monitoring Engagement(Baseline to 1-month and 3 months)
- Self-Efficacy(Baseline, 1 month, 3 months)
- Mastery(Baseline, 1 month, 3 months)
- Self-Regulation(Baseline, 1 month, 3 months)
- Proportion of Individuals Achieving ≥ 5% Weight Loss(Baseline to 3 months)
- Change in Caloric Intake(Baseline, 3 months)