Trial Outcomes & Findings for Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions (NCT NCT05751993)
NCT ID: NCT05751993
Last Updated: 2026-08-21
Results Overview
Self-monitoring adherence will be defined as the percent of days, averaged across participants, in which participants tracked at least one weight loss behavior (tracked calories, wore tracker, or self-weighed).
COMPLETED
NA
19 participants
up to 12 weeks
2026-08-21
Participant Flow
Recruitment occurred in April 2025 in the Raleigh-Durham-Chapel Hill geographic area.
Individuals who signed informed consent were asked to complete baseline measurement procedures (online surveys and a remote weight measurement). After completing baseline procedures, participants started the program.
Participant milestones
| Measure |
ADAPT Intervention
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Overall Study
STARTED
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19
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
Baseline characteristics by cohort
| Measure |
ADAPT Intervention
n=19 Participants
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Age, Continuous
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40.7 years
STANDARD_DEVIATION 9.1 • n=5 Participants
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Sex/Gender, Customized
Female
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13 Participants
n=5 Participants
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Sex/Gender, Customized
Male
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6 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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6 Participants
n=5 Participants
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Race (NIH/OMB)
White
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9 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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17 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: up to 12 weeksPopulation: This analysis includes all 19 participants who completed the 12-week program.
Feasibility as the success of using the AdaptRL model will be defined as the mean number of messages delivered per participant per day.
Outcome measures
| Measure |
ADAPT Intervention
n=19 Participants
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Feasibility: Messages Delivered
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1.47 messages per participant per day
Standard Deviation 0.53
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PRIMARY outcome
Timeframe: up to 12 weeksPopulation: This analysis includes all 19 participants who completed the 12-week program.
Study engagement will be defined as the percent of days, averaged across participants, with logins to the web application.
Outcome measures
| Measure |
ADAPT Intervention
n=19 Participants
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Study Engagement: Percent of Days With Logins
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24.12 percent of days
Standard Deviation 26.58
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PRIMARY outcome
Timeframe: up to 12 weeksPopulation: This analysis includes all 19 participants who completed the 12-week program.
Self-monitoring adherence will be defined as the percent of days, averaged across participants, in which participants tracked at least one weight loss behavior (tracked calories, wore tracker, or self-weighed).
Outcome measures
| Measure |
ADAPT Intervention
n=19 Participants
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Self-monitoring Adherence
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95.4 percent of days
Standard Deviation 10.2
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SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants with a 12-week weight value (N = 19).
Percent weight loss will be defined as weight change from baseline to 12 weeks calculated as a percent from baseline weight.
Outcome measures
| Measure |
ADAPT Intervention
n=19 Participants
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Percent Weight Loss
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-3.49 % weight change
Standard Deviation 4.64
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SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: This analysis includes participants who completed the Paffenbarger Activity Questionnaire at both baseline and 12 weeks (n=18).
Moderate-to-vigorous physical activity will be defined as the change in self-reported weekly minutes of moderate-to-vigorous physical activity as measured by the Paffenbarger Activity Questionnaire from baseline to 12 weeks. The minimum is 0, no maximum. Higher numbers represent a greater increase in minutes of weekly moderate-to-vigorous physical activity.
Outcome measures
| Measure |
ADAPT Intervention
n=18 Participants
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Change in Moderate-to-vigorous Physical Activity Minutes
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45.4 minutes per week
Standard Deviation 112.4
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SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: This analysis includes all participants who completed at least one dietary recall at both baseline and 12 weeks (N=19).
Change in dietary intake will be defined as the change in average daily calorie intake as measured by the Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 12 weeks. Daily caloric intake is measured in kcals, with higher numbers indicating higher caloric intake. Negative change values reflect decreases in daily caloric intake from baseline to 12 weeks.
Outcome measures
| Measure |
ADAPT Intervention
n=19 Participants
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Change in Dietary Intake
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-304.1 kcal/day
Standard Deviation 696.0
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SECONDARY outcome
Timeframe: up to 12 weeksPopulation: This analysis includes all 19 participants who completed the 12-week program.
Adherence to the calorie goal as the mean percent of days in which participants tracked their calories and stayed at or under their calorie goal will be measured by dietary self-monitoring data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers.
Outcome measures
| Measure |
ADAPT Intervention
n=19 Participants
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Adherence to Calorie Goal
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43.0 percent of days
Standard Deviation 24.4
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SECONDARY outcome
Timeframe: up to 12 weeksPopulation: This analysis includes all 19 participants who completed the 12-week program.
Adherence to daily active minutes goal, the mean percent of days in which participants met their daily active minutes goal, will be measured by activity tracker data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers.
Outcome measures
| Measure |
ADAPT Intervention
n=19 Participants
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Adherence to Daily Active Minutes Goal
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65.4 percent of days
Standard Deviation 24.7
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SECONDARY outcome
Timeframe: up to 12 weeksPopulation: This analysis includes all 19 participants who completed the 12-week program.
Adherence to daily self-weighing, the mean percent of days in which participants self-weighed will be measured by Fitbit smart scales and transmitted via Application Programming Interface (API) to study servers.
Outcome measures
| Measure |
ADAPT Intervention
n=19 Participants
Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
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Adherence to Daily Self-weighing
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71.2 percent of days
Standard Deviation 22.8
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Adverse Events
ADAPT Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brooke Nezami, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place