Miro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment
Optimizing Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: A Micro-randomized Trial
1 other identifier
interventional
204
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Oct 2021
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedStudy Start
First participant enrolled
October 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
January 21, 2026
January 1, 2026
4.6 years
February 25, 2021
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dietary Lapses
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.
up to 6 months
Secondary Outcomes (4)
Objectively-measured Eating Frequency
Daily for 2 weeks after each assessment period
Objectively-measured Eating Duration
Daily for 2 weeks after each assessment period
Objectively-measured Eating Rate
Daily for 2 weeks after each assessment period
Objectively-measured Estimated Caloric Intake
Daily for 2 weeks after each assessment period
Other Outcomes (22)
JITAI Tailoring Variable: Hunger
Daily over 6 months
JITAI Tailoring Variable: Cravings
Daily over 6 months
JITAI Tailoring Variable: Missed Meals
Daily over 6 months
- +19 more other outcomes
Study Arms (6)
Enhanced Education
EXPERIMENTALTheory-driven intervention focused on providing information about dietary quality and goals
Self-efficacy
EXPERIMENTALTheory-driven intervention focused on providing skills to increase self-efficacy for following dietary goals
Motivation
EXPERIMENTALTheory-driven intervention focused on providing skills to increase motivation for following dietary goals
Self-regulation
EXPERIMENTALTheory-driven intervention focused on providing skills to increase self-regulation
Generic Risk Alert
ACTIVE COMPARATORA notification to alert participant of lapse risk, no additional intervention provided
No Intervention
SHAM COMPARATORNo notification or intervention is delivered to the participant during lapse risk
Interventions
This 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).
To provide variety in this intervention option and limit time spent in a single intervention, components are split into 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").
There are 4 independent modules that prompt self-monitoring and self-awareness efforts: 1) advise participants to record everything that they eat before they eat it, with attention to eating in the subsequent few hours; 2) use 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) advise participants to track portion sizes carefully and provide a portion size guide that is available to them until the following EMA survey; OR 4) provide a tutorial on noticing hunger/satiety cues and slowing down rate of eating, with an experiential exercise for use during their next eating episode.
Participants will be notified 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.").
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.
The "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.
Eligibility Criteria
You may qualify if:
- Age 18-70
- Body mass index (BMI) between 25 and 50 kg/m-squared
- Diagnosis of one or more cardiovascular disease risk factors (prediabetes, type 2 diabetes, hypercholesterolemia, or hypertension)
- Able to walk 2 city blocks without stopping
You may not qualify if:
- Currently participating in another weight loss program
- Currently taking weight loss medication
- Lost \> 5% of their body weight in the 6 months prior to enrolling
- Has been pregnant within the 6 months prior to enrolling
- Plans to become pregnant within 6 months of enrolling
- Has chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
- Has any medical condition that would affect the safety of participating in unsupervised physical activity
- Has history of bariatric surgery
- Has any condition that would result in inability to follow the study protocol, including terminal illness, substance abuse, eating disorder (not including Binge Eating Disorder) and untreated major psychiatric illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903, United States
Related Publications (1)
Goldstein SP, Zhang F, Klasnja P, Hoover A, Wing RR, Thomas JG. Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial. JMIR Res Protoc. 2021 Dec 6;10(12):e33568. doi: 10.2196/33568.
PMID: 34874892DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Participants and investigators will not need to be masked to condition, as conditions are randomized sequentially according to a pre-established algorithm.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 5, 2021
Study Start
October 26, 2021
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
January 21, 2026
Record last verified: 2026-01