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

University of North Carolina (UNC)

Status: Active, not recruiting

Conditions: Overweight; Overweight and Obesity; Obesity

Treatments: Behavioral: Core Behavioral Weight Loss (BWL) Intervention; Behavioral: Behavior Change Technique 1 Message (Action Planning); Behavioral: Behavior Change Technique 3 Message (Feedback on Outcome of Behavior); Behavioral: Behavior Change Technique 7 Message (Focus on Past Success); Behavioral: Behavior Change Technique 4 Message (Social Support); Behavioral: Behavior Change Technique 2 Message (Discrepancy between Current Behavior and Goal); Behavioral: Behavior Change Technique 5 Message (Social Comparison); Behavioral: Behavior Change Technique 6 Message (Social Reward)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05625061

22-0170

1R01HL161373 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No 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

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 6 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
• Have participated in another study conducted by the UNC Weight Research Program within the past 12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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206 participants in 8 patient groups

Core Behavioral Weight Loss (BWL) Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Core Behavioral Weight Loss (BWL) Intervention

Core BWL Intervention + BCT 1 Message (Action Planning)

Experimental group

Description:

Core BWL Intervention + Message testing the Behavior Change Technique "Action Planning"

Treatment:

Behavioral: Behavior Change Technique 1 Message (Action Planning)

Core BWL Intervention + BCT 2 Message (Discrepancy)

Experimental group

Description:

Core BWL Intervention + Message testing the Behavior Change Technique "Discrepancy Between Current Behavior and Goal"

Treatment:

Behavioral: Behavior Change Technique 2 Message (Discrepancy between Current Behavior and Goal)

Core BWL Intervention + BCT 3 Message (Feedback on Outcome of Behavior)

Experimental group

Description:

Core BWL Intervention + Message testing the Behavior Change Technique "Feedback on Outcome of Behavior"

Treatment:

Behavioral: Behavior Change Technique 3 Message (Feedback on Outcome of Behavior)

Core BWL Intervention + BCT 4 Message (Social Support)

Experimental group

Description:

Core BWL Intervention + Message testing the Behavior Change Technique "Social Support"

Treatment:

Behavioral: Behavior Change Technique 4 Message (Social Support)

Core BWL Intervention + BCT 5 Message (Social Comparison)

Experimental group

Description:

Core BWL Intervention + Message testing the Behavior Change Technique "Social Comparison"

Treatment:

Behavioral: Behavior Change Technique 5 Message (Social Comparison)

Core BWL Intervention + BCT 6 Message (Social Reward)

Experimental group

Description:

Core BWL Intervention + Message testing the Behavior Change Technique "Social Reward"

Treatment:

Behavioral: Behavior Change Technique 6 Message (Social Reward)

Core BWL Intervention + BCT 7 Message (Focus on Past Success)

Experimental group

Description:

Core BWL Intervention + Message testing the Behavior Change Technique "Focus on Past Success"

Treatment:

Behavioral: Behavior Change Technique 7 Message (Focus on Past Success)