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临床试验/NCT05625061
NCT05625061已完成不适用

A Micro-randomized Trial of JITAI Messaging to Improve Adherence to Multiple Weight Loss Behaviors in Young Adults

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2023年8月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
255
试验地点
1
主要终点
Met Daily Weighing Goal

研究概览

简要总结

The purpose of this micro-randomized trial is to evaluate the effects of 7 types of intervention messages targeting specific behavior change techniques (i.e., BCT messages) delivered in "just-in-time" (JIT) moments on daily achievement of weight-related behavioral goals among n=201 young adults with overweight and obesity, participating in a digital, mobile comprehensive lifestyle intervention. "Just-in-time adaptive interventions" (JITAIs) are an alternative to the "one size fits all" approach of mobile intervention development that can provide tailored, real-time messaging and support for young adults.

详细描述

An estimated 1 in 2 US adults will have obesity by 2030, which is a major cause of morbidity and mortality. The highest risk of weight gain is among young adults ages 18-35 years. In-person behavioral interventions generally produce clinically significant weight losses, but cost and reduced reach limit their ability to impact obesity at a population level. Web-based interventions that mimic the structure of weekly face-to-face treatment have proven a viable alternative, though weight losses are generally smaller than in-person treatment. Mobile treatments have the potential for high reach, but have been less effective, producing 1-3 kgs over 6 months. Newer digital intervention approaches called "just-in-time adaptive interventions" (JITAIs) promise to improve upon mobile outcomes by offering adaptive, personalized feedback on behavior, which consists of providing the "right type of support" at "the right time" rather than on a fixed schedule. This "just-in- time," or JIT, approach is made possible by the emergence of low-cost and widely available digital health tools that allow for the collection of continually updated health data. However, to date, no JITAIs have successfully targeted multiple weight-related behaviors (weighing, activity, and diet), and there has been no systematic examination of what types of messaging interventions best promote adherence to these three weight loss behaviors, for whom they are effective, and under what conditions. To address this problem, a micro-randomized trial will be used to evaluate the effects of 7 types of intervention messages targeting specific behavior change techniques (i.e., BCT messages) delivered in JIT moments on daily achievement of behavioral goals among n=201 young adults with overweight and obesity. All participants will receive a 6-month behavioral weight loss intervention using our Nudge mobile app, which includes evidence-based weekly lessons, tailored feedback, self-monitoring, and daily BCT messages. Participants will receive a wireless scale, activity tracker, and track "red" foods (high-calorie foods) in the app and have 3 goals: weigh daily, a daily active minutes goal that gradually increases if met, and a daily red foods limit. At 3 decision points per day, participants will be micro-randomized to receive or not receive 1 of 7 types of BCT messages. Each intervention message has unique decision rules for availability. Candidate intervention message options have been carefully selected from empirical evidence, tested in our prior studies, or are from our pilot micro-randomized trial. Assessments will occur daily, and at 0, 3 and 6 months, to accomplish the following specific aims: 1) Evaluate the effects of each behavior change technique message (i.e., BCT message) on daily adherence to weight loss behaviors; 2) Determine whether the effects of BCT messages on proximal outcomes change over time; and 3) Assess whether the effects of BCT messages on proximal outcomes are moderated by participants' contextual factors. Findings will guide how adaptive, behaviorally- and contextually-dependent messages are incorporated into future JITAIs for weight loss.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) of 25 - 45 kg/m^2 at baseline
  • English-speaking, reading, and writing
  • Own a smartphone with a data and text messaging plan

排除标准

  • Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
  • Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4).
  • Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis
  • Lost 10 lbs. or more of body weight (and kept it off) in the last 6 months
  • Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa)
  • Current symptoms of alcohol or substance dependence
  • Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
  • Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months
  • Hospitalization for depression or other psychiatric disorder within the past 12 months
  • History of psychotic disorder or bipolar disorder
  • Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
  • Currently using prescription medications with known effects on appetite or weight (e.g., oral steroids, weight loss medications), with the exception of individuals on a stable dose of Selective Serotonin Reuptake Inhibitors (SSRIs) for 3 months)
  • Previous surgical procedure for weight loss or planned weight loss surgery in the next year
  • Another member of the household is a participant or staff member on this trial
  • Reason to suspect that the participant would not adhere to the study intervention
  • Reside outside of the United States
  • Have participated in another study conducted by the UNC Weight Research Program within the past 12 months

研究组 & 干预措施

Core Behavioral Weight Loss (BWL) Intervention

Experimental

Behavioral weight loss core intervention, includes activity tracker, wireless scale, daily self-weighing, and smartphone app with weekly behavioral lessons, food tracking log, weekly tailored feedback summary, and daily weight-related behavioral goals. Core intervention component is combined with each of the 7 intervention messages to be tested repeatedly over time.

干预措施: Core Behavioral Weight Loss (BWL) Intervention (Behavioral)

Core BWL Intervention + BCT 1 Message (Action Planning)

Experimental

Core BWL Intervention + Message testing the Behavior Change Technique "Action Planning"

干预措施: Behavior Change Technique 1 Message (Action Planning) (Behavioral)

Core BWL Intervention + BCT 2 Message (Discrepancy)

Experimental

Core BWL Intervention + Message testing the Behavior Change Technique "Discrepancy Between Current Behavior and Goal"

干预措施: Behavior Change Technique 2 Message (Discrepancy between Current Behavior and Goal) (Behavioral)

Core BWL Intervention + BCT 3 Message (Feedback on Outcome of Behavior)

Experimental

Core BWL Intervention + Message testing the Behavior Change Technique "Feedback on Outcome of Behavior"

干预措施: Behavior Change Technique 3 Message (Feedback on Outcome of Behavior) (Behavioral)

Core BWL Intervention + BCT 4 Message (Social Support)

Experimental

Core BWL Intervention + Message testing the Behavior Change Technique "Social Support"

干预措施: Behavior Change Technique 4 Message (Social Support) (Behavioral)

Core BWL Intervention + BCT 5 Message (Social Comparison)

Experimental

Core BWL Intervention + Message testing the Behavior Change Technique "Social Comparison"

干预措施: Behavior Change Technique 5 Message (Social Comparison) (Behavioral)

Core BWL Intervention + BCT 6 Message (Social Reward)

Experimental

Core BWL Intervention + Message testing the Behavior Change Technique "Social Reward"

干预措施: Behavior Change Technique 6 Message (Social Reward) (Behavioral)

Core BWL Intervention + BCT 7 Message (Focus on Past Success)

Experimental

Core BWL Intervention + Message testing the Behavior Change Technique "Focus on Past Success"

干预措施: Behavior Change Technique 7 Message (Focus on Past Success) (Behavioral)

结局指标

主要结局

Met Daily Weighing Goal

时间窗: Daily throughout the study, a total of up to 24 weeks

Each observation corresponds to a microrandomization decision point; the reported value reflects the outcome measured within that unit. Among the randomization observations in which the participant had not yet weighed, this outcome is the number of observations in which the daily weighing goal was met after receiving or not receiving a message and before the end of the day. Observations are accumulated across participants and across time. On the day of randomization, a dichotomous outcome of whether a participant weighed or did not weigh is calculated.

Met Daily Active Minutes Goal

时间窗: Daily throughout the study, a total of up to 24 weeks

Each observation corresponds to a microrandomization decision point; the reported value reflects the outcome measured within that unit. Among the randomization observations in which the participant had not yet met their active minutes goal, this outcome is the number of observations in which the daily active minutes goal was met after receiving or not receiving a message and before the end of the day. Observations are accumulated across participants and across time. On the day of randomization, a dichotomous outcome of whether a participant met or did not meet their active minutes goal is calculated.

At or Under Daily Red Foods Limit

时间窗: Daily throughout the study, a total of up to 24 weeks

Each observation corresponds to a microrandomization decision point; the reported value reflects the outcome measured within that unit. Among the randomization observations in which the participant had not yet exceeded their red foods limit, this outcome is the number of observations in which the participant stayed at or under their daily red foods limit after receiving or not receiving a message and before the end of the day. Observations are accumulated across participants and across time. On the day of randomization, a dichotomous outcome of whether a participant stayed at or under their red foods limit or did not is calculated.

次要结局

  • Weight Change(Baseline, 6 months)
  • Percent Weight Change(Baseline, 6 months)
  • Proportion of Days Met Daily Weighing Goal(Daily throughout the study, a total of up to 24 weeks)
  • Proportion of Daily Active Minutes Goal Met(Daily throughout the study, a total of up to 24 weeks)
  • Proportion of Daily Red Foods Limit(Daily throughout the study, a total of up to 24 weeks)
  • Number of Active Minutes(Daily throughout the study, a total of up to 24 weeks)
  • Number of Red Foods(Daily throughout the study, a total of up to 24 weeks)
  • Met Daily Weighing Goal Tomorrow(Daily throughout the study, a total of up to 24 weeks)
  • Met Daily Active Minutes Goal Tomorrow(Daily throughout the study, a total of up to 24 weeks)
  • At or Under Daily Red Foods Limit Tomorrow(Daily throughout the study, a total of up to 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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