An interventional study of PLAN-RT 1.0 in Women's Health, Obesity & Overweight and Perimenopausal Women, sponsored by Louisiana State University and A&M College. Not yet recruiting at 1 site in United States. Open to female participants aged 40 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Louisiana State University and A&M College · Not applicable, Interventional, and Prevention
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?
GLP-1 receptor agonist (GLP-1RA) therapies have emerged as highly effective pharmacological treatments for obesity, yet weight loss achieved through these agents is accompanied by significant lean mass loss. This is particularly relevant for midlife women who are concurrently vulnerable to age- and menopause-related declines in skeletal muscle mass and physical function. Resistance training (RT) is recommended as an evidence-based strategy for preserving lean mass during weight loss treatments, yet no theory-grounded, scalable intervention exists to support RT initiation and maintenance in midlife women. PLAN-RT 1.0 is a 12-week, app-delivered resistance training intervention developed for midlife women (aged 40-59) receiving GLP-1RA therapy for obesity. The intervention integrates three complementary theoretical frameworks - Self-Regulation Theory (initiation), Habit Formation Theory (cue-behavior-reward), and the Affective Response Theory (intrinsic reinforcement) - operationalized through a structured set of behavior change techniques delivered via digital health technologies. This proposed single-arm feasibility pilot (n=15) pursues two specific aims. Aim 1 evaluates the feasibility and acceptability of PLAN-RT 1.0 using pre-specified benchmarks across enrollment, adherence, retention, and ecological momentary assessment (EMA) response rate, alongside exploratory pre-post analyses of body composition, muscle strength and physical function, and behavioral outcomes. Aim 2 examines the mechanistic role of affective response to RT as a driver of habit formation, using EMA-based per-session affective valence data and mixed methods to characterize how GLP-1RA-mediated dopaminergic changes may alter the intrinsic reward signal from exercise. Feasibility benchmarks, variance estimates, and mechanistic insights from PLAN-RT 1.0 will directly inform the development of PLAN-RT 2.0 through an R21 factorial optimization trial (MOST framework) and ultimately an R01 efficacy trial, establishing a scalable clinical tool for lean mass preservation in midlife women receiving GLP-1RA therapy.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 15 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Louisiana State University and A&M College is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Participants must meet all of the following criteria:
Exclusion Criteria: Participants will be excluded if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive PLAN-RT 1.0, a 12-week digitally delivered resistance training intervention designed for physically inactive midlife women (ages 40-59 years) who have recently initiated GLP-1 receptor agonist (GLP-1RA) therapy. The intervention combines a Fitbit Versa smartwatch, LIT AXIS™ smart resistance band, and smartphone applications integrated through the Pathverse platform to support resistance training participation. Participants will receive exercise instruction and form guidance, personalized resistance training goal setting, implementation intention-based action planning, contextual prompts delivered through smartwatch notifications, self-monitoring of exercise behavior, and feedback on goal attainment. Resistance training activities include bodyweight and resistance band exercises performed according to a structured progressive program over 12 weeks.
Behavioral: PLAN-RT 1.0
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.
Number of adults screened (Participants)
Number of adults screened for eligibility for the study
Time frame: Weekly throughout recruitment
Intervention Acceptability (CSQ-8)
Acceptability 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
Time frame: Week 12
Number of Adults Enrolled (Participants)
Number of adults who met eligibility criteria and enrolled in the study
Time frame: Weekly throughout recruitment
Retention Rate (Percentage of enrolled participants)
Proportion of enrolled participants who completed the 12-week study
Time frame: Week 4, 8, 12
Change in Body Weight in Kilograms
Body weight will be measured using a calibrated digital scale in kilograms. Change from baseline to Week 12 will be evaluated.
Time frame: Baseline and Week 12
Intervention Usability (SUS)
Usability will be assessed using the System Usability Scale (SUS). Scores range from 0 to 100, with higher scores indicating greater usability.
Time frame: Week 12
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 7 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Louisiana State University and A&M College