Adaptive Goals and Interventions for Lifestyle Enhancement

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor: University of North Carolina, Chapel Hill
Study ID: NCT04922216
Status: Completed

Conditions

Obesity

Eligibility Criteria

Sex: ALL
Age: 18 Years - 39 Years
Healthy Volunteers: Not accepted

Interventions

Core — BEHAVIORAL
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Standard Diet Monitoring — BEHAVIORAL
Standard monitoring using smartphone tracking of all calorie intake.
Simplified Diet Monitoring — BEHAVIORAL
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Adaptive Activity Goals (Daily) — BEHAVIORAL
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Adaptive Activity Goals (Weekly) — BEHAVIORAL
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Message Decision Points (Fixed) — BEHAVIORAL
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Message Decision Points (Adaptive) — BEHAVIORAL
Message timing is adaptive and derived from individual user data to determine message eligibility.
Message Decision Rules (Standard) — BEHAVIORAL
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Message Decision Rules (Adaptive) — BEHAVIORAL
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Message Choice (No) — BEHAVIORAL
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
Message Choice (Yes) — BEHAVIORAL
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Study Details

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.

Key Dates

Start date: Apr 28, 2022
Status verified: Oct 2023
Primary completion: Jun 20, 2024
Completion: Jul 1, 2024

Study Design

Enrollment: 759 participants (actual)
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Arms

Experimental: Condition 1
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice
Experimental: Condition 2
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice
Experimental: Condition 3
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice
Experimental: Condition 4
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice
Experimental: Condition 5
Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice
Experimental: Condition 6
Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice
Experimental: Condition 7
Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Experimental: Condition 8
Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice
Experimental: Condition 9
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice
Experimental: Condition 10
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice
Experimental: Condition 11
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice
Experimental: Condition 12
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice
Experimental: Condition 13
Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice
Experimental: Condition 14
Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice
Experimental: Condition 15
Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Experimental: Condition 16
Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice
Experimental: Condition 17
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice
Experimental: Condition 18
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice
Experimental: Condition 19
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice
Experimental: Condition 20
Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice
Experimental: Condition 21
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice
Experimental: Condition 22
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice
Experimental: Condition 23
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Experimental: Condition 24
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice
Experimental: Condition 25
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice
Experimental: Condition 26
Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice
Experimental: Condition 27
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice
Experimental: Condition 28
Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice
Experimental: Condition 29
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice
Experimental: Condition 30
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice
Experimental: Condition 31
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Experimental: Condition 32
Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice

Primary Outcome Measure

Weight (kg) [ Time Frame: Baseline, 6 months ]

Locations (1)

Facility	City	State	ZIP	Site coordinators
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27514	-

Find similar trials in Chapel Hill, NC

By condition

Obesity / overweight

By specialty

Endocrinology Metabolic health Weight loss

By research site

University of North Carolina at Chapel Hill· Chapel Hill, NC

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