Adaptive Goals and Interventions for Lifestyle Enhancement (AGILE)
July 18, 2025 updated by: University of North Carolina, Chapel Hill
Optimization of a mHealth Behavioral Weight Loss Intervention for Young Adults
Mobile obesity interventions have the potential to reach a diverse population in need; however, while effective, have not resulted in weight losses obtained in in-person interventions.
Newer digital approaches called Just-in-Time Adaptive Interventions (JITAI) that offer adaptive, personalized feedback 'when needed' and in 'real time' offer an opportunity to use digital health tools "just in time".
This study seeks to identify the optimal components of a comprehensive weight loss JITAI that results in weight losses that meet or exceed those in existing remotely delivered interventions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Behavioral: Core
- Behavioral: Standard Diet Monitoring
- Behavioral: Adaptive Activity Goals (Daily)
- Behavioral: Message Decision Points (Fixed)
- Behavioral: Message Decision Rules (Standard)
- Behavioral: Message Choice (No)
- Behavioral: Message Choice (Yes)
- Behavioral: Message Decision Rules (Adaptive)
- Behavioral: Message Decision Points (Adaptive)
- Behavioral: Adaptive Activity Goals (Weekly)
- Behavioral: Simplified Diet Monitoring
Detailed Description
Obesity has reached epidemic proportions in the United States and is recognized as a major cause of morbidity and mortality.
Young adults (18-35 years) are at particularly high risk for weight gain and obesity.
In-person behavioral interventions generally produce clinically significant weight losses; however, cost and access limit their potential to reduce obesity at a population level.
Although web-based interventions that mimic the structure of weekly face-to-face treatment have proven a viable alternative treatment, weight losses are generally smaller than in-person treatment.
Exclusively mobile treatments 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 outcomes by offering adaptive, personalized feedback on behavior "when needed" in "real 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, few studies have used JIT approaches in remotely delivered, fully scalable weight loss interventions.
Although JITAIs are a potentially transformative approach to delivering obesity interventions, a major obstacle in their development is efficient selection of components and systematic design of an optimized intervention package that produces clinically meaningful weight losses with a population-level strategy.
To solve this problem, this trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to identify which levels of 5 intervention components contribute meaningfully to change in weight over 6 months among young adults with overweight and obesity.
All participants (n=608) will receive a core 6-month weight loss intervention that includes evidence-based lessons, behavioral skills training, and daily weighing.
With the goal of determining if greater adaptation will lead to greater weight loss, participants will be randomized to standard versus more adaptive options of 5 additional intervention components: 1) diet monitoring approach (standard vs. simplified), 2) adaptive physical activity goals (weekly vs. daily), 3) decision points for message timing (fixed vs. adaptive), 4) decision rules for message content (standard vs. adaptive), and 5) message choice (no vs. yes).
Candidate components have been carefully selected from empirical evidence, tested in prior studies conducted by the research team, or in a pilot micro-randomized trial conducted by the research team.
Assessments will occur at 0, 3 and 6 months to accomplish the following specific aims: 1) Build an optimized JITAI consisting of the set of intervention components that yield the greatest improvement in weight change among young adults at 6 months; 2) Conduct mediation analyses to test the relationships between the intervention components and hypothesized proximal mediators (self-regulation, competence, relatedness, relevance, autonomy) and more distal behavioral mediators (dietary intake, physical activity, and daily self-weighting); and 3) Conduct exploratory analyses of program engagement.
Study Type
Interventional
Enrollment (Actual)
759
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- body mass index (BMI) of 25-45 kg/m^2
- English-speaking and writing
- own a smartphone with a data and text messaging plan
- willing to be randomized to any levels of the factors
Exclusion Criteria:
- Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
- 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
- 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)
- Lost 10 or more pounds (and kept it off) in the last 6 months
- Currently taking weight loss medications
- Report a past diagnosis of or current treatment for a DSM-V (Diagnostic and Statistical Manual 5) eating disorder (anorexia nervosa or bulimia nervosa)
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
- Hospitalization for depression or other psychiatric disorder within the past 12 months
- History of psychotic disorder or bipolar disorder
- Another member of the household is a participant or staff member on this trial
- Currently participating in a weight loss, nutrition or physical activity study or program or other study that would interfere with this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Condition 1
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
|
|
Experimental: Condition 2
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
|
|
Experimental: Condition 3
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
|
|
Experimental: Condition 4
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
|
|
Experimental: Condition 5
Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Message timing is adaptive and derived from individual user data to determine message eligibility.
|
|
Experimental: Condition 6
Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Message timing is adaptive and derived from individual user data to determine message eligibility.
|
|
Experimental: Condition 7
Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Message timing is adaptive and derived from individual user data to determine message eligibility.
|
|
Experimental: Condition 8
Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Message timing is adaptive and derived from individual user data to determine message eligibility.
|
|
Experimental: Condition 9
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
|
|
Experimental: Condition 10
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
|
|
Experimental: Condition 11
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
|
|
Experimental: Condition 12
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
|
|
Experimental: Condition 13
Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Message timing is adaptive and derived from individual user data to determine message eligibility.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
|
|
Experimental: Condition 14
Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Message timing is adaptive and derived from individual user data to determine message eligibility.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
|
|
Experimental: Condition 15
Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Message timing is adaptive and derived from individual user data to determine message eligibility.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
|
|
Experimental: Condition 16
Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard monitoring using smartphone tracking of all calorie intake.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Message timing is adaptive and derived from individual user data to determine message eligibility.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
|
|
Experimental: Condition 17
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 18
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 19
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 20
Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 21
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Message timing is adaptive and derived from individual user data to determine message eligibility.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 22
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Message timing is adaptive and derived from individual user data to determine message eligibility.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 23
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Message timing is adaptive and derived from individual user data to determine message eligibility.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 24
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Message timing is adaptive and derived from individual user data to determine message eligibility.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 25
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 26
Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 27
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 28
Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 29
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Message timing is adaptive and derived from individual user data to determine message eligibility.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 30
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Message timing is adaptive and derived from individual user data to determine message eligibility.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 31
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Message timing is adaptive and derived from individual user data to determine message eligibility.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
|
Experimental: Condition 32
Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice
|
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Message timing is adaptive and derived from individual user data to determine message eligibility.
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight (kg)
Time Frame: Baseline, 6 months
|
Estimated mean weight change in kg from baseline to 6 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
More negative values of weight change indicate greater weight loss (6-month weight - baseline weight).
|
Baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight (kg)
Time Frame: Baseline, 3 months
|
Estimated mean weight change in kg from baseline to 3 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).
|
Baseline, 3 months
|
|
Percent of Participants Reaching >/= 5% Weight Loss
Time Frame: Baseline to 6 months
|
Percent change in body weight will be calculated (6 month weight - baseline weight/100) and determined to be at or above 5% indicating a clinically significant change.
|
Baseline to 6 months
|
|
Diet
Time Frame: Baseline, 6 months
|
Change in daily caloric intake from baseline to 6 months as measured using the self-administered National Cancer Institute's Automated Self- Administered 24-hour Recall (ASA-24), a 24-hour recall that is self-administered on a week day and a weekend day at each timepoint.
Change calculated as (daily kcal at 6 months - daily kcal at baseline).
|
Baseline, 6 months
|
|
Physical Activity
Time Frame: Baseline,3 months, 6 months
|
Change in physical activity from baseline to 3 and 6 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ).
The PPAQ assesses amount of planned and lifestyle associated physical activity performed during a typical week.
The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation.
Participants report the frequency and duration of physical activity in the past week.
Scoring yields energy expenditure from physical activity per week (kcal/week).
Higher scores translate into greater energy expenditure per week (i.e.,better outcome).
Range is 0 - no theoretical maximum.
Outcome is change in kcal burned per week.
|
Baseline,3 months, 6 months
|
|
Sedentary Behavior Score
Time Frame: Baseline, 3 months, 6 months
|
Change in sedentary behavior from baseline to 3 and 6 months as measured using the 12- item Sedentary Behavior Questionnaire which asks respondents to indicate the number of hours they spend on a typical weekday and a typical weekend day doing each of six activities.
The scale ranges from "none" to "6 or more hours" for each item.
Higher values on the Sedentary Behavior Questionnaire indicate greater amount of time spent in sedentary behavior.
Range is 0 to 24 hours and outcome is change in minutes per day.
|
Baseline, 3 months, 6 months
|
|
Autonomy Support Score
Time Frame: 3 months, 6 months
|
Autonomy support at 3 and 6 months.
Items are adapted from the Health Care Climate Questionnaire, which is a measure of how the participant perceives support from a healthcare provider, to measure autonomy support from the program.
The scale includes 15 items rated on a scale of 1 (strongly disagree) to 7 (strongly agree) (e.g., "I feel that [the program] has provided me choices and options.")
Scores are calculated by averaging the individual item scores (with item 13 reverse-scored).
Higher average scores represent a higher level of perceived autonomy support.
Outcomes are the mean value at 3 months and the mean value at 6 months.
|
3 months, 6 months
|
|
Competence for Diet and Physical Activity Scores
Time Frame: Baseline, 3 months, 6 months
|
Change in perceived competence from baseline to 3 and 6 months as measured using the The Perceived Competence Scale.
The Scale measures perceived competence for diet (4 items) and physical activity (4 items).
Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet."
Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors.
Scores are summed for the items in each subscale separately (diet and physical activity).
Outcomes are change in perceived competence for diet and change in perceived competence for physical activity.
|
Baseline, 3 months, 6 months
|
|
Perceived Message Relevance Score
Time Frame: 3 months, 6 months
|
Perceived message relevance at 3 and 6 months as measured using two items used in our previous work and adapted from previous studies of tailored messages.
Participants were asked to rate how strongly they disagree or agree with the statements about messages being "written personally for me" and "applied to my life."
Responses are on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree).
The values of the two items are averaged for a final score.
Higher values indicate that a participant perceives the messages received in the program are more relevant to them.
|
3 months, 6 months
|
|
Treatment Self-Regulation Score
Time Frame: Baseline, 3 months, 6 months
|
Change in treatment self-regulation from baseline to 3 and 6 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are: Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19 Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for diet at 3 and 6 months, and changes in autonomous and controlled motivation for activity at 3 and 6 months. |
Baseline, 3 months, 6 months
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Relatedness Score
Time Frame: 3 months, 6 months
|
Relatedness at 3 and 6 months as measured with 3 items adapted from the 8-item Relatedness subscale of the Basic Need Satisfaction at Work Scale.
Examples include "The messages demonstrate caring about me as a person" and are scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree).
Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived relatedness from the intervention messages.
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3 months, 6 months
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Diet Self-monitoring Adherence
Time Frame: Baseline to 6 months (daily)
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Mean number of days of complete dietary tracking summed over the 6-month study period.
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Baseline to 6 months (daily)
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Weighing Adherence
Time Frame: Baseline to 6 months (daily)
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Mean number of days of self-weighing over the 6 month period.
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Baseline to 6 months (daily)
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Physical Activity Self-monitoring Adherence
Time Frame: Baseline to 6 months (daily)
|
Mean number of days of physical activity tracking over the 6 month period as measured by Fitbit tracker wear.
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Baseline to 6 months (daily)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Deborah F. Tate, PhD, University of North Carolina, Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 28, 2022
Primary Completion (Actual)
June 20, 2024
Study Completion (Actual)
July 1, 2024
Study Registration Dates
First Submitted
June 4, 2021
First Submitted That Met QC Criteria
June 4, 2021
First Posted (Actual)
June 10, 2021
Study Record Updates
Last Update Posted (Actual)
July 20, 2025
Last Update Submitted That Met QC Criteria
July 18, 2025
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 20-0765
- R01DK125779 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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