Opening soonNot applicableInterventional
What this study is about
The goal of PLAN-RT 1.0 to learn if a 12-week app-based strength training program can help midlife women build and stick with a regular strength training routine while they are taking GLP-1 medication for weight loss. PLAN-RT 1.0 targets women ages 40 to 59 who were not regularly exercising before starting GLP-1 medication. The main questions this study aims to answer are: (1) Is the PLAN-RT 1.0 program feasible and acceptable to participants (based on how many people join, stay in the study, and use the program)? (2) Does the program lead to early changes in muscle strength, body composition, physical function, and exercise habits?
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age40 Years to 59 Years
SexFemale
Healthy volunteersNot accepted
ConditionWomen's Health, Obesity & Overweight, Perimenopausal Women, Digital Intervention, Behavior Change, glp1 Agonist, Resistance Exercise
Full registry criteria
Inclusion Criteria: Participants must meet all of the following criteria: * Female, age 40 to 54 years. * Recently initiated GLP-1 receptor agonist (GLP-1RA) therapy within the past 6 months. * Body mass index (BMI) ≥27 kg/m². * Not currently participating in regular resistance training (self-reported absence of regular resistance training during the previous month). * Able to stand, sit, and perform bodyweight movements without assistive devices. * Owns a compatible smartphone (iOS or Android) with cellular or Wi-Fi access and is willing to use study applications. * Able to read, understand, and provide informed consent in English. * Willing and able to attend required in-person study visits. Exclusion Criteria: Participants will be excluded if they meet any of the following criteria: * Plans to discontinue GLP-1RA therapy or substantially modify treatment during the 12-week study period. * Self-reported musculoskeletal injury, orthopedic limitation, or surgery within the previous 6 months that would contraindicate resistance training participation. * Self-reported unstable cardiovascular disease or cardiac event within the previous 6 months. * Currently pregnant or planning to become pregnant during the study period. * Active eating disorder or psychiatric condition that may interfere with study participation. * Unable to use smartphone applications required for the intervention. * Current participation in another pharmacological, behavioral, weight management, or chronic disease management program that could confound study outcomes.
Treatments and study arms
PLAN-RT 1.0
Behavioral
A 12-week theory-based, app-delivered resistance training behavioral intervention incorporating behavior change techniques based on Self-Regulation Theory and Habit Formation Theory to promote initiation and maintenance of resistance training among midlife women receiving GLP-1RA therapy. The intervention includes exercise instruction, goal setting, action planning, contextual cues, self-monitoring, and feedback delivered through integrated digital health technologies.
Primary outcomes
Number of adults screened (Participants)Weekly throughout recruitmentNumber of adults screened for eligibility for the study
Intervention Acceptability (CSQ-8)Week 12Acceptability will be assessed using the Client Satisfaction Questionnaire-8 (CSQ-8). Higher scores indicate greater participant satisfaction with the intervention. Score on a scale, typically 0-32 for CSQ-8
Number of Adults Enrolled (Participants)Weekly throughout recruitmentNumber of adults who met eligibility criteria and enrolled in the study
Retention Rate (Percentage of enrolled participants)Week 4, 8, 12Proportion of enrolled participants who completed the 12-week study
