临床试验/NCT04922216

NCT04922216已完成不适用

Optimization of a mHealth Behavioral Weight Loss Intervention for Young Adults

University of North Carolina, Chapel Hill1 个研究点分布在 1 个国家目标入组 759 人开始时间: 2022年4月28日最近更新: 2025年7月20日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of North Carolina, Chapel Hill
入组人数: 759
试验地点: 1
主要终点: Weight (kg)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Mobile obesity interventions have the potential to reach a diverse population in need; however, while effective, have not resulted in weight losses obtained in in-person interventions. Newer digital approaches called Just-in-Time Adaptive Interventions (JITAI) that offer adaptive, personalized feedback 'when needed' and in 'real time' offer an opportunity to use digital health tools "just in time". This study seeks to identify the optimal components of a comprehensive weight loss JITAI that results in weight losses that meet or exceed those in existing remotely delivered interventions.

详细描述

Obesity has reached epidemic proportions in the United States and is recognized as a major cause of morbidity and mortality. Young adults (18-35 years) are at particularly high risk for weight gain and obesity. In-person behavioral interventions generally produce clinically significant weight losses; however, cost and access limit their potential to reduce obesity at a population level. Although web-based interventions that mimic the structure of weekly face-to-face treatment have proven a viable alternative treatment, weight losses are generally smaller than in-person treatment. Exclusively mobile treatments 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 outcomes by offering adaptive, personalized feedback on behavior "when needed" in "real 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, few studies have used JIT approaches in remotely delivered, fully scalable weight loss interventions. Although JITAIs are a potentially transformative approach to delivering obesity interventions, a major obstacle in their development is efficient selection of components and systematic design of an optimized intervention package that produces clinically meaningful weight losses with a population-level strategy. To solve this problem, this trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to identify which levels of 5 intervention components contribute meaningfully to change in weight over 6 months among young adults with overweight and obesity. All participants (n=608) will receive a core 6-month weight loss intervention that includes evidence-based lessons, behavioral skills training, and daily weighing. With the goal of determining if greater adaptation will lead to greater weight loss, participants will be randomized to standard versus more adaptive options of 5 additional intervention components: 1) diet monitoring approach (standard vs. simplified), 2) adaptive physical activity goals (weekly vs. daily), 3) decision points for message timing (fixed vs. adaptive), 4) decision rules for message content (standard vs. adaptive), and 5) message choice (no vs. yes). Candidate components have been carefully selected from empirical evidence, tested in prior studies conducted by the research team, or in a pilot micro-randomized trial conducted by the research team. Assessments will occur at 0, 3 and 6 months to accomplish the following specific aims: 1) Build an optimized JITAI consisting of the set of intervention components that yield the greatest improvement in weight change among young adults at 6 months; 2) Conduct mediation analyses to test the relationships between the intervention components and hypothesized proximal mediators (self-regulation, competence, relatedness, relevance, autonomy) and more distal behavioral mediators (dietary intake, physical activity, and daily self-weighting); and 3) Conduct exploratory analyses of program engagement.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
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: 否

入选标准

•body mass index (BMI) of 25-45 kg/m^2
•English-speaking and writing
•own a smartphone with a data and text messaging plan
•willing to be randomized to any levels of the factors

排除标准

•Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
•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
•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)
•Lost 10 or more pounds (and kept it off) in the last 6 months
•Currently taking weight loss medications
•Report a past diagnosis of or current treatment for a DSM-V (Diagnostic and Statistical Manual 5) eating disorder (anorexia nervosa or bulimia nervosa)
•Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
•Hospitalization for depression or other psychiatric disorder within the past 12 months
•History of psychotic disorder or bipolar disorder
•Another member of the household is a participant or staff member on this trial
•Currently participating in a weight loss, nutrition or physical activity study or program or other study that would interfere with this study

研究组 & 干预措施

Condition 1

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Core (Behavioral)

Condition 1

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 1

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 1

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 1

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 1

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 2

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Core (Behavioral)

Condition 2

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 2

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 2

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 2

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 2

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 3

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Core (Behavioral)

Condition 3

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 3

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 3

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 3

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 3

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 6

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 6

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 6

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 4

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Core (Behavioral)

Condition 4

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 4

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 4

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 4

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 4

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 5

Experimental

Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Core (Behavioral)

Condition 5

Experimental

Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 5

Experimental

Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 5

Experimental

Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 5

Experimental

Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 5

Experimental

Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 6

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Core (Behavioral)

Condition 6

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 6

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 7

Experimental

Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Core (Behavioral)

Condition 7

Experimental

Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 7

Experimental

Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 7

Experimental

Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 7

Experimental

Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 7

Experimental

Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 8

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Core (Behavioral)

Condition 8

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 8

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 8

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 8

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 8

Experimental

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 9

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Core (Behavioral)

Condition 9

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 9

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 9

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 9

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 9

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 10

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Core (Behavioral)

Condition 10

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 10

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 10

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 10

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 10

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 11

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Core (Behavioral)

Condition 11

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 11

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 11

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 11

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 11

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 12

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Core (Behavioral)

Condition 12

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 12

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 12

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 12

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 12

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 13

Experimental

Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Core (Behavioral)

Condition 13

Experimental

Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 13

Experimental

Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 13

Experimental

Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 13

Experimental

Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 13

Experimental

Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 14

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Core (Behavioral)

Condition 14

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 14

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 14

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 14

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 14

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 15

Experimental

Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Core (Behavioral)

Condition 15

Experimental

Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 15

Experimental

Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 15

Experimental

Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 15

Experimental

Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 15

Experimental

Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 16

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Core (Behavioral)

Condition 16

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Standard Diet Monitoring (Behavioral)

Condition 16

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 16

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 16

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 16

Experimental

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 17

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Core (Behavioral)

Condition 17

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 17

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 17

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 17

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 17

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 18

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice

干预措施: Core (Behavioral)

Condition 18

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 18

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 18

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 18

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 18

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 19

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Core (Behavioral)

Condition 19

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 19

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 19

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 19

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 19

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 20

Experimental

Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Core (Behavioral)

Condition 20

Experimental

Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 20

Experimental

Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 20

Experimental

Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 20

Experimental

Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 20

Experimental

Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 21

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Core (Behavioral)

Condition 21

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 21

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 21

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 21

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 21

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 22

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Core (Behavioral)

Condition 22

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 22

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 22

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 22

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 22

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 23

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Core (Behavioral)

Condition 23

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 23

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 23

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 23

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 23

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 24

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice

干预措施: Core (Behavioral)

Condition 24

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 24

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice

干预措施: Adaptive Activity Goals (Daily) (Behavioral)

Condition 24

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 24

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 24

Experimental

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 25

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Core (Behavioral)

Condition 25

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 25

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 25

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 25

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 25

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 26

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Core (Behavioral)

Condition 26

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 26

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 26

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 32

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 26

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 26

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 27

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Core (Behavioral)

Condition 27

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 27

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 27

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 27

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 27

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 28

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Core (Behavioral)

Condition 28

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 28

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 28

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Decision Points (Fixed) (Behavioral)

Condition 28

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 28

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 29

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Core (Behavioral)

Condition 29

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 29

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 29

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 29

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 29

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 30

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Core (Behavioral)

Condition 30

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 30

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 30

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 30

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Message Decision Rules (Standard) (Behavioral)

Condition 30

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice

干预措施: Message Choice (Yes) (Behavioral)

Condition 31

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Core (Behavioral)

Condition 31

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Simplified Diet Monitoring (Behavioral)

Condition 31

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 31

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 31

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 31

Experimental

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

干预措施: Message Choice (No) (Behavioral)

Condition 32

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice

干预措施: Core (Behavioral)

Condition 32

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice

干预措施: Adaptive Activity Goals (Weekly) (Behavioral)

Condition 32

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice

干预措施: Message Decision Points (Adaptive) (Behavioral)

Condition 32

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice

干预措施: Message Decision Rules (Adaptive) (Behavioral)

Condition 32

Experimental

Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice

干预措施: Message Choice (Yes) (Behavioral)

结局指标

主要结局

Weight (kg)

时间窗: Baseline, 6 months

Estimated mean weight change in kg from baseline to 6 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (6-month weight - baseline weight).

次要结局

Diet(Baseline, 6 months)
Physical Activity(Baseline,3 months, 6 months)
Weight (kg)(Baseline, 3 months)
Percent of Participants Reaching >/= 5% Weight Loss(Baseline to 6 months)
Diet(Baseline, 6 months)
Physical Activity(Baseline,3 months, 6 months)
Sedentary Behavior Score(Baseline, 3 months, 6 months)
Autonomy Support Score(3 months, 6 months)
Competence for Diet and Physical Activity Scores(Baseline, 3 months, 6 months)
Perceived Message Relevance Score(3 months, 6 months)
Treatment Self-Regulation Score(Baseline, 3 months, 6 months)
Relatedness Score(3 months, 6 months)
Diet Self-monitoring Adherence(Baseline to 6 months (daily))
Weighing Adherence(Baseline to 6 months (daily))
Physical Activity Self-monitoring Adherence(Baseline to 6 months (daily))

研究者

发起方

University of North Carolina, Chapel Hill

申办方类型

Other

责任方

Sponsor

研究点 (1)

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