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

Obesity Clinical Trial

— Nudge  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05625061
• Other study ID #: 22-0170
• Secondary ID: 1R01HL161373
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

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)
• 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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

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.
• 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).
• 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.
• 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).
• 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).
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Met daily weighing goal	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.	Daily throughout the study, a total of up to 24 weeks
Primary	Met daily active minutes goal	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.	Daily throughout the study, a total of up to 24 weeks
Primary	At or under daily red foods limit	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.	Daily throughout the study, a total of up to 24 weeks
Secondary	Weight change	Absolute weight change (kg) from baseline to 6 months. Weight will be objectively measured on a digital scale in the participant's home.	Baseline, 6 months
Secondary	Percent weight change	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	Baseline, 6 months
Secondary	Proportion of days met daily weighing goal	Calculation of the proportion of study days weighed.	Daily throughout the study, a total of up to 24 weeks
Secondary	Proportion of daily active minutes goal met	Calculation of the proportion of daily active minutes goal met using activity tracker data.	Daily throughout the study, a total of up to 24 weeks
Secondary	Proportion of daily red foods limit	Calculation of the proportion of the daily red foods limit recorded in the study app.	Daily throughout the study, a total of up to 24 weeks
Secondary	Number of active minutes	Total number of active minutes on the day of message randomization (at the participant-day level) across the 6 month study.	Daily throughout the study, a total of up to 24 weeks
Secondary	Number of red foods	Total number of red foods on the day of message randomization (at the participant-day level) across the 6 month study.	Daily throughout the study, a total of up to 24 weeks
Secondary	Met daily weighing goal tomorrow	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.	Daily throughout the study, a total of up to 24 weeks
Secondary	Met daily active minutes goal tomorrow	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).	Daily throughout the study, a total of up to 24 weeks
Secondary	At or under daily red foods limit tomorrow	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.	Daily throughout the study, a total of up to 24 weeks