Adaptive Goals and Interventions for Lifestyle Enhancement

NCT04922216 | Completed Results

• 2 other identifiers: 20-0765R01DK125779
• Study Type: interventional
• Target: 759
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

behavioral intervention; JITAI (just-in-time adaptive intervention)

Outcome Measures

Primary Outcomes (1)

• Weight (kg)

  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 Outcomes (13)

• Weight (kg)

  Baseline, 3 months

• Percent of Participants Reaching >/= 5% Weight Loss

  Baseline to 6 months

• Diet

  Baseline, 6 months

• Physical Activity

  Baseline,3 months, 6 months

• Sedentary Behavior Score

  Baseline, 3 months, 6 months

Study Arms (32)

Condition 1

EXPERIMENTAL

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

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)

Condition 2

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)

Condition 3

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)

Condition 4

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)

Condition 5

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)

Condition 6

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)

Condition 7

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)

Condition 8

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)

Condition 9

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)

Condition 10

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)

Condition 11

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)

Condition 12

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)

Condition 13

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)

Condition 14

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)

Condition 15

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)

Condition 16

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)

Condition 17

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)

Condition 18

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)

Condition 19

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)

Condition 20

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)

Condition 21

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)

Condition 22

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)

Condition 23

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)

Condition 24

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)

Condition 25

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)

Condition 26

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)

Condition 27

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)

Condition 28

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)

Condition 29

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)

Condition 30

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)

Condition 31

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)

Condition 32

EXPERIMENTAL

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

Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)

Interventions

Core BEHAVIORAL

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

Condition 1; Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 17; Condition 18; Condition 19; Condition 2; Condition 20; Condition 21; Condition 22; Condition 23; Condition 24; Condition 25; Condition 26; Condition 27; Condition 28; Condition 29; Condition 3; Condition 30; Condition 31; Condition 32; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8; Condition 9

Standard Diet Monitoring BEHAVIORAL

Standard monitoring using smartphone tracking of all calorie intake.

Condition 1; Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8; Condition 9

Simplified Diet Monitoring BEHAVIORAL

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

Condition 17; Condition 18; Condition 19; Condition 20; Condition 21; Condition 22; Condition 23; Condition 24; Condition 25; Condition 26; Condition 27; Condition 28; Condition 29; Condition 30; Condition 31; Condition 32

Adaptive Activity Goals (Daily) BEHAVIORAL

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

Condition 1; Condition 17; Condition 18; Condition 19; Condition 2; Condition 20; Condition 21; Condition 22; Condition 23; Condition 24; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8

Adaptive Activity Goals (Weekly) BEHAVIORAL

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

Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 25; Condition 26; Condition 27; Condition 28; Condition 29; Condition 30; Condition 31; Condition 32; Condition 9

Message Decision Points (Fixed) BEHAVIORAL

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

Condition 1; Condition 10; Condition 11; Condition 12; Condition 17; Condition 18; Condition 19; Condition 2; Condition 20; Condition 25; Condition 26; Condition 27; Condition 28; Condition 3; Condition 4; Condition 9

Message Decision Points (Adaptive) BEHAVIORAL

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

Condition 13; Condition 14; Condition 15; Condition 16; Condition 21; Condition 22; Condition 23; Condition 24; Condition 29; Condition 30; Condition 31; Condition 32; Condition 5; Condition 6; Condition 7; Condition 8

Message Decision Rules (Standard) BEHAVIORAL

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

Condition 1; Condition 10; Condition 13; Condition 14; Condition 17; Condition 18; Condition 2; Condition 21; Condition 22; Condition 25; Condition 26; Condition 29; Condition 30; Condition 5; Condition 6; Condition 9

Message Decision Rules (Adaptive) BEHAVIORAL

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

Condition 11; Condition 12; Condition 15; Condition 16; Condition 19; Condition 20; Condition 23; Condition 24; Condition 27; Condition 28; Condition 3; Condition 31; Condition 32; Condition 4; Condition 7; Condition 8

Message Choice (No) BEHAVIORAL

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

Condition 1; Condition 11; Condition 13; Condition 15; Condition 17; Condition 19; Condition 21; Condition 23; Condition 25; Condition 27; Condition 29; Condition 3; Condition 31; Condition 5; Condition 7; Condition 9

Message Choice (Yes) BEHAVIORAL

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

Condition 10; Condition 12; Condition 14; Condition 16; Condition 18; Condition 2; Condition 20; Condition 22; Condition 24; Condition 26; Condition 28; Condition 30; Condition 32; Condition 4; Condition 6; Condition 8

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

YES1 protein, human

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Brooke Nezami, PhD
• Organization: University of North Carolina at Chapel Hill

bnezami@unc.edu

919-966-5852

Study Officials

• Deborah F. Tate, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a full factorial experimental design testing the efficacy of five intervention components, each with two levels

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: April 28, 2022
• Primary Completion: June 20, 2024
• Study Completion: July 1, 2024
• Last Updated: July 20, 2025
• Results First Posted: July 20, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)