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NCT05751993
Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
Conditions: Overweight and Obesity, Overweight, Obesity
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 20
Sponsor: UNC Lineberger Comprehensive Cancer Center
Location: United States
Summary
The purpose of this pilot study is to conduct a 12-week pilot feasibility study testing usability of the adapt learning tool (AdaptRL)in a weight loss intervention (ADAPT study).
Building upon a previous just-in-time adaptive intervention (JITAI), a reinforcement learning tool will generate decision rules regarding which behavior change techniques, in which contexts, are most efficacious for promoting weight loss in a sample of 20 adults.
Eligibility Criteria
Inclusion Criteria:Age 18-55 yearsBody Mass Index of 25-40 kg/m2Not adhering to the US physical activity guidelines of at least 150 moderate-to-vigorous intensity activity minutes/weekEnglish-speaking and writingNo pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, diabetes treated with insulin, history of heart attack or stroke, current treatment for cancer, or inability to walk for exerciseHas a smartphone with a data and text messaging planExclusion Criteria:Current participation in another weight loss, physical activity, nutrition program, or research studyCurrently taking weight loss medicationsCurrently pregnant or planning pregnancy in the next 3 monthsLost 10 or more pounds and kept it off in the last 6 monthsHistory of weight loss surgeryReport a heart condition, chest pain during periods of activity or rest, loss of consciousness, joint or bone problems, medical conditions that could limit exercise, or prescription medicine used for blood pressure or heart condition on the Physical Activity Readiness Questionnaire (PAR-Q)Type 1 diabetes or currently receiving medical treatment for Type 2 diabetesCancer treatment within the past 5 yearsTuberculosisHealth or psychological diagnoses that preclude participation in a prescribed dietary and exercise program, including diagnosis of schizophrenia or bipolar disorder, hospitalization for a psychiatric diagnosis in the past year, a diagnosis of alcohol or substance abuseReport a past diagnosis of or receiving treatment for The Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa).Moving out of the area in the next 4 monthsOut of town for a week or more during the study periodAnother member of the household is a participant or staff member in this trialNot willing to attend two study visitsNot willing to wear a Fitbit every day
Source: ClinicalTrials.gov (NCT05751993). StuddyBuddy aggregates publicly available trial information.