Adaptive Goals and Interventions for Lifestyle Enhancement

NCT ID: NCT04922216

Last Updated: 2025-07-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

759 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-28

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This study uses a full factorial experimental design testing the efficacy of five intervention components, each with two levels
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Condition 1

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 2

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 3

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 4

Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 5

Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 6

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 7

Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 8

Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 9

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 10

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 11

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 12

Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 13

Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 14

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 15

Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 16

Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Standard Diet Monitoring

Intervention Type BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 17

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 18

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 19

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 20

Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 21

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 22

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 23

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 24

Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Daily)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 25

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 26

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 27

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 28

Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Fixed)

Intervention Type BEHAVIORAL

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 29

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 30

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Standard)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Condition 31

Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (No)

Intervention Type BEHAVIORAL

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Condition 32

Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice

Group Type EXPERIMENTAL

Core

Intervention Type BEHAVIORAL

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Simplified Diet Monitoring

Intervention Type BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Adaptive Activity Goals (Weekly)

Intervention Type BEHAVIORAL

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Message Decision Points (Adaptive)

Intervention Type BEHAVIORAL

Message timing is adaptive and derived from individual user data to determine message eligibility.

Message Decision Rules (Adaptive)

Intervention Type BEHAVIORAL

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Message Choice (Yes)

Intervention Type BEHAVIORAL

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Interventions

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Core

Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

Intervention Type BEHAVIORAL

Standard Diet Monitoring

Standard monitoring using smartphone tracking of all calorie intake.

Intervention Type BEHAVIORAL

Simplified Diet Monitoring

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Intervention Type BEHAVIORAL

Adaptive Activity Goals (Daily)

Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

Intervention Type BEHAVIORAL

Adaptive Activity Goals (Weekly)

Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

Intervention Type BEHAVIORAL

Message Decision Points (Fixed)

Message timing is fixed and evaluated at specific times each day to determine message eligibility.

Intervention Type BEHAVIORAL

Message Decision Points (Adaptive)

Message timing is adaptive and derived from individual user data to determine message eligibility.

Intervention Type BEHAVIORAL

Message Decision Rules (Standard)

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

Intervention Type BEHAVIORAL

Message Decision Rules (Adaptive)

Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

Intervention Type BEHAVIORAL

Message Choice (No)

Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

Intervention Type BEHAVIORAL

Message Choice (Yes)

Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah F. Tate, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01DK125779

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-0765

Identifier Type: -

Identifier Source: org_study_id

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