Nudge: Just-in-time Adaptive Intervention Messaging in a Digital Weight Loss Intervention for Young Adults

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05625061

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

201

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Overweight and Obesity	Behavioral: Core Behavioral Weight Loss (BWL) Intervention Behavioral: Behavior Change Technique 1 Message (Action Planning) Behavioral: Behavior Change Technique 2 Message (Discrepancy between Current Behavior and Goal) Behavioral: Behavior Change Technique 3 Message (Feedback on Outcome of Behavior) Behavioral: Behavior Change Technique 4 Message (Social Support) Behavioral: Behavior Change Technique 5 Message (Social Comparison) Behavioral: Behavior Change Technique 6 Message (Social Reward) Behavioral: Behavior Change Technique 7 Message (Focus on Past Success)	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

201 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

This is a micro-randomized trial, a form of a sequential, factorial trial. At every time point, a participant is micro-randomized to receive or not receive an intervention message.This is a micro-randomized trial, a form of a sequential, factorial trial. At every time point, a participant is micro-randomized to receive or not receive an intervention message.

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Core Behavioral Weight Loss (BWL) Intervention 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.	Behavioral: Core Behavioral Weight Loss (BWL) Intervention All participants receive a mobile behavioral weight loss intervention delivered through a study smartphone app with weekly behavioral lessons, food tracking log, weekly tailored feedback, and daily weight-related behavioral goals; a connected physical activity tracker and wireless scale. As micro-randomized trials are sequential, full factorial experiments, this core intervention component is combined with each of the 7 intervention messages (i.e., Behavior Change Technique (BCT) messages) to be tested repeatedly over time. Participants will be evaluated at each of 3 decision points (morning, midday, evening) on each day of the study, and if eligible then micro-randomized, to receive or not receive, 1 of 7 types of daily intervention messages promoting achievement of proximal weight-related behavioral goals.
Experimental: Core BWL Intervention + BCT 1 Message (Action Planning) Core BWL Intervention + Message testing the Behavior Change Technique "Action Planning"	Behavioral: Behavior Change Technique 1 Message (Action Planning) Core BWL Intervention + Message in smartphone app prompts detailed planning of performance of one of the 3 target behaviors (daily weighing, active minutes, red food intake).
Experimental: Core BWL Intervention + BCT 2 Message (Discrepancy) Core BWL Intervention + Message testing the Behavior Change Technique "Discrepancy Between Current Behavior and Goal"	Behavioral: Behavior Change Technique 2 Message (Discrepancy between Current Behavior and Goal) Core BWL Intervention + Message in smartphone app provides feedback on each of the 3 target behaviors (daily weighing, active minutes, red food intake) in the form of information drawing attention to discrepancies between participants' current behavior and participants' daily goals.
Experimental: Core BWL Intervention + BCT 3 Message (Feedback on Outcome of Behavior) Core BWL Intervention + Message testing the Behavior Change Technique "Feedback on Outcome of Behavior"	Behavioral: Behavior Change Technique 3 Message (Feedback on Outcome of Behavior) Core BWL Intervention + Message in smartphone app provides participants with feedback on their weight change, relating it to their performance on one of the 3 target behaviors (daily weighing, active minutes, red food intake).
Experimental: Core BWL Intervention + BCT 4 Message (Social Support) Core BWL Intervention + Message testing the Behavior Change Technique "Social Support"	Behavioral: Behavior Change Technique 4 Message (Social Support) Core BWL Intervention + Message in smartphone app advises participants on eliciting the provision of social support from their existing network related to one of the 3 target behaviors (daily weighing, active minutes, red food intake).
Experimental: Core BWL Intervention + BCT 5 Message (Social Comparison) Core BWL Intervention + Message testing the Behavior Change Technique "Social Comparison"	Behavioral: Behavior Change Technique 5 Message (Social Comparison) Core BWL Intervention + Message in smartphone app systematically induces comparison of participants' behavioral performance with other participants, including general, upward (i.e., comparison to participants doing better: weighing more, engaging in more activity, staying within red food limits), and downward comparisons (to participants doing worse).
Experimental: Core BWL Intervention + BCT 6 Message (Social Reward) Core BWL Intervention + Message testing the Behavior Change Technique "Social Reward"	Behavioral: Behavior Change Technique 6 Message (Social Reward) Core BWL Intervention + Message in smartphone app reinforces participants' effort or progress in performing one of the 3 target behaviors (daily weighing, active minutes, red food intake).
Experimental: Core BWL Intervention + BCT 7 Message (Focus on Past Success) Core BWL Intervention + Message testing the Behavior Change Technique "Focus on Past Success"	Behavioral: Behavior Change Technique 7 Message (Focus on Past Success) Core BWL Intervention + Message in smartphone app advises participants to think about or list previous successes related to performing one of the 3 target behaviors (daily weighing, active minutes, red food intake).

Outcome Measures

Primary Outcome Measures

Met daily weighing goal [Daily throughout the study, a total of up to 24 weeks]
Wireless scales will be used to collect daily weight measurements, which are transmitted directly to the study app servers in real time. Participants are instructed to weigh each day. On the day of randomization, a dichotomous outcome of whether a participant weighed or did not weigh is assessed.
Met daily active minutes goal [Daily throughout the study, a total of up to 24 weeks]
Activity trackers will be used to collect daily active minutes, which are minutes of moderate-to-vigorous intensity physical activity accumulated in bouts of at least 10 minutes. On the day of randomization, a dichotomous outcome of whether a participant met or exceeded their daily active minutes goal or not is assessed. Days with no tracker wear are counted as not meeting the goal.
At or under daily red foods limit [Daily throughout the study, a total of up to 24 weeks]
Participants will record red foods in the study app; data sync with study servers in real time from the participants' app. On the day of randomization, a dichotomous outcome of whether a participant stayed at or under their red foods limit or not is assessed. Days without complete red food tracking are counted as not meeting the red foods limit.

Secondary Outcome Measures

Weight change [Baseline, 6 months]
Absolute weight change (kg) from baseline to 6 months. Weight will be objectively measured on a digital scale in the participant's home.
Percent weight change [Baseline, 6 months]
Change in weight (%) from baseline to 6 months. Weight will be objectively measured on a digital scale in the participant's home. Percent weight change at 6 months is calculated as ((weight (kg) at 6 months - weight (kg) at baseline)/(weight (kg) at baseline))*100
Proportion of days met daily weighing goal [Daily throughout the study, a total of up to 24 weeks]
Calculation of the proportion of study days weighed.
Proportion of daily active minutes goal met [Daily throughout the study, a total of up to 24 weeks]
Calculation of the proportion of daily active minutes goal met using activity tracker data.
Proportion of daily red foods limit [Daily throughout the study, a total of up to 24 weeks]
Calculation of the proportion of the daily red foods limit recorded in the study app.
Number of active minutes [Daily throughout the study, a total of up to 24 weeks]
Total number of active minutes on the day of message randomization (at the participant-day level) across the 6 month study.
Number of red foods [Daily throughout the study, a total of up to 24 weeks]
Total number of red foods on the day of message randomization (at the participant-day level) across the 6 month study.
Met daily weighing goal tomorrow [Daily throughout the study, a total of up to 24 weeks]
Wireless scales will be used to collect daily weight measurements, which are transmitted directly to the study app servers in real time. Participants are instructed to weigh each day. On the day after randomization, a dichotomous outcome of whether a participant weighed or did not weigh is assessed.
Met daily active minutes goal tomorrow [Daily throughout the study, a total of up to 24 weeks]
Activity trackers will be used to collect daily active minutes, which are minutes of moderate-to-vigorous intensity physical activity accumulated in bouts of at least 10 minutes. On the day after randomization, a dichotomous outcome of whether a participant met or exceeded their daily active minutes goal or not is assessed. (Days with no tracker wear are counted as not meeting the goal).
At or under daily red foods limit tomorrow [Daily throughout the study, a total of up to 24 weeks]
Participants will record red foods in the study app; data sync with study servers in real time from the participants' app. On the day after randomization, a dichotomous outcome of whether a participant stayed at or under their red foods limit or not is assessed. Days without complete red food tracking are counted as not meeting the red foods limit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
Achieve fewer than 210 minutes/week of moderate to vigorous intensity physical activity at baseline

Exclusion Criteria:

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 3 months
Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa) or any compensatory behaviors within the previous 3 months
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