Clinical trial NCT05625061: Just-in-time Adaptive Intervention Messaging in a Digital Weight Loss Intervention for Young Adults
Official title: A Micro-randomized Trial of JITAI Messaging to Improve Adherence to Multiple Weight Loss Behaviors in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Overweight and Obesity
Keywords: Mobile intervention
Diet
Physical Activity
Behavioral weight loss
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-11-22
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Met daily weighing goal
timeFrame: Daily throughout the study, a total of up to 24 weeks
measure: Met daily active minutes goal
timeFrame: Daily throughout the study, a total of up to 24 weeks
measure: At or under daily red foods limit
timeFrame: Daily throughout the study, a total of up to 24 weeks
Secondary outcomes:
measure: Weight change
timeFrame: Baseline, 6 months
measure: Percent weight change
timeFrame: Baseline, 6 months
measure: Proportion of days met daily weighing goal
timeFrame: Daily throughout the study, a total of up to 24 weeks
measure: Proportion of daily active minutes goal met
timeFrame: Daily throughout the study, a total of up to 24 weeks
measure: Proportion of daily red foods limit
timeFrame: Daily throughout the study, a total of up to 24 weeks
measure: Number of active minutes
timeFrame: Daily throughout the study, a total of up to 24 weeks
measure: Number of red foods
timeFrame: Daily throughout the study, a total of up to 24 weeks
measure: Met daily weighing goal tomorrow
timeFrame: Daily throughout the study, a total of up to 24 weeks
measure: Met daily active minutes goal tomorrow
timeFrame: Daily throughout the study, a total of up to 24 weeks
measure: At or under daily red foods limit tomorrow
timeFrame: Daily throughout the study, a total of up to 24 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: Assistant Professor
name: Carmina G. Valle, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: