Clinical trial
Miro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04784585
What this study is about
This project targets dietary lapses (instances of nonadherence to dietary goals), a major cause of poor outcomes during behavioral obesity treatment, which is a recommended first-line intervention for cardiovascular disease. The investigators propose to conduct a micro-randomized trial (MRT) to empirically optimize a smartphone-based just-in-time adaptive intervention (JITAI) that monitors risk and intervenes on lapses as needed. By evaluating the immediate, proximal effect of four theory-driven interventions on lapse behavior, the project will: (a) produce a scalable, finalized JITAI that has the greatest potential to show clear clinical impact in future trials; and (b) inform the development of more sophisticated theoretical models of adherence behavior more broadly. Therefore, this study has three goals. First the investigators aim to compare the effects of delivering any intervention to no intervention on the occurrence of lapse. Second, the investigators aim to compare the effects of specific theory-driven interventions to one another to determine which ones are best for preventing lapses. Within this second aim, the investigators also aim to examine other factors that may influence the effectiveness of interventions (e.g., time, location). Lastly, the investigators will use the data from this MRT to customize intervention delivery in future versions of this JITAI Patients will be recruited through various methods including advertisements in local media, targeted online advertising, advertisements in medical and minority communities, and direct mailers. All participants will receive a well-established 3-month online obesity treatment program, with 3 months of no-treatment follow-up. In conjunction, they will use a smartphone-based JITAI consisting of: 1) repeated daily surveys assess lapses and relevant triggers; 2) a machine learning algorithm that uses information from the surveys to determine real-time lapse risk; \& 3) interventions to counter lapse risk. When an individual is at risk for lapsing she will be randomly assigned to no intervention, a generic risk alert, or one of 4 theory-driven interventions with interactive skills training. The outcome of interest will be the occurrence (or lack thereof) of dietary lapse, as measured both subjectively (i.e., reported by the participant in the daily surveys) and objectively (i.e., via wrist-based intake monitoring), in the hours following randomization initiated by heightened lapse risk.
Basic eligibility
Full registry criteria
Treatments and study arms
JITAI Enhanced Education Intervention Option
The JITAI "Enhanced Education" intervention option seeks to: 1) enhance understanding of personal health-behavior links, 2) improve health literacy by checking the adequacy of participant understanding, and 3) remind participant of important elements of Behavioral Obesity Treatment (BOT) dietary goals.
JITAI Self-Efficacy Intervention Option
The JITAI "Self-Efficacy" intervention option is based on a previously established self-efficacy intervention for weight loss, which is a multi-component intervention for increasing self-efficacy. To provide variety in this intervention option and limit time spent in a single intervention, components are split into independent modules that either prompt: 1) attainable intention setting related to dietary adherence (e.g., "I will focus on eating mostly fruits/vegetables in my next meal/snack in order to take back control of my eating"); 2) barrier identification for adhering to dietary goals along with a brief problem-solving exercise; 3) devising a small self-reward; OR 4) self-assessment of thoughts/behaviors that could interfere with dietary adherence in the next several hours with coping strategies (e.g., stimulus control, social support).
JITAI Motivation Intervention Option
The JITAI "Motivation" intervention option contains independent modules that either: 1) guide participants in identifying values related to weight control (e.g., longevity, quality of life, being a role model) and connect those values to their behavior in the current moment.; 2) use a collaborative non-judgmental approach to explore the consequences of letting barriers drive behavior (e.g., "Take a moment to consider the effect on your longevity if you let your preference for sweets determine your behavior."); 3) prompt participants to identify reasons for change, thereby eliciting "change talk"; OR 4) engage participants in a brief self-assessment of motivation for dietary adherence (i.e., "On a scale of 1-10, how important to you is it to stick to your dietary goals today").
JITAI Self-Regulation Intervention Option
The JITAI "Self-Regulation" intervention option prompts self-monitoring and self-awareness efforts via: 1) advising participants to record everything that they eat before they eat it, with attention to eating in the subsequent few hours; 2) using the "traffic light" model to enhance awareness of dietary intake. This module provides the traffic light categories of foods (i.e., green=healthiest choices, yellow=sometimes choices, and red=rare choices), and asks participants to check-off foods that they intend to eat vs. stay away from in the next few hours; 3) advising participants to track portion sizes carefully and provide a portion size guide that is available to them until the following EMA survey; OR 4) providing a tutorial on noticing hunger/satiety cues and slowing down rate of eating, with an experiential exercise for use during their next eating episode.
JITAI Generic Risk Alert Intervention Option (Active Comparator)
The JITAI "Risk Alert" intervention option informs the participant that the JITAI algorithm has determined heightened lapse risk in the following 2-3 hours (i.e., "We have detected that your risk of lapsing from your weight loss diet is higher than usual and may require attention.").
Online Behavioral Obesity Treatment
The online BOT consists of: (a) 12 weekly multimedia lessons for training in behavioral weight loss skills; (b) online tools for self-monitoring weight, diet, and physical activity; and (c) weekly automated text-based feedback on progress to date. Participants are given a goal of losing 1-2lbs per week to achieve a total weight loss of ≥10% of initial body weight. Participants are prescribed a calorie goal of 1200-1800 kcal/day tailored on initial weight. Participants are given guidelines to follow a lowfat or Mediterranean diet to meet the prescribed calorie goal. Participants are given a physical activity goal tailored on initial activity level that gradually increases to 200 min/wk of activity, emphasizing brisk walking as the primary form of activity. They also receive a primer in self-monitoring weight, diet, and physical activity. Participants are instructed to self-monitor and follow the prescribed diet for the 6-month study period.
JITAI No Treatment Intervention Option
No notification or intervention is delivered to the participant when JITAI predicts dietary lapse risk
Primary outcomes
Dietary lapses will be assessed via ecological momentary assessment (EMA) embedded within the JITAI. Participants receive EMA surveys 6x per day and each survey asks about dietary lapses since completing the prior survey.
Study locations
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