Women's HealthPLAN-RTNCT07787533
Digital Resistance Training for Midlife Women Using GLP-1
A study testing PLAN-RT 1.0 in people with Women's Health and Obesity & Overweight, run by Louisiana State University and A&M College at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 59 years, women only
- Conditions the study is for
- Women's Health, Obesity & Overweight, Perimenopausal Women
- What is being tested?
- PLAN-RT 1.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- Women only
- No healthy volunteers
- Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Louisiana State University School of Kinesiology
Baton Rouge, Louisiana, 70803
Shiyu Li, Ph.D., 225-578-0977, sli40@lsu.edu
Kimberly M Allen, M.A., 225-578-2363, kmallen@lsu.edu
About this study
Official title: Developing a Scalable Digital Resistance Training Intervention to Preserve Muscle Function in Midlife Women Receiving GLP-1 Therapy
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?
Read the detailed description
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.
- Conditions
- Women's Health, Obesity & Overweight, Perimenopausal Women, Digital Intervention, Behavior Change, glp1 Agonist
- Being tested
- PLAN-RT 1.0
- Keywords
- resistance training, women's health, obesity, perimenopausal women, digital intervention
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAN-RT 1.0Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PLAN-RT 1.0 | Experimental | 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. Receives: Behavioral: PLAN-RT 1.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adults screened (Participants)
Number of adults screened for eligibility for the study
Measured: 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
Measured: Week 12
Number of Adults Enrolled (Participants)
Number of adults who met eligibility criteria and enrolled in the study
Measured: Weekly throughout recruitment
Retention Rate (Percentage of enrolled participants)
Proportion of enrolled participants who completed the 12-week study
Measured: Week 4, 8, 12
Secondary outcomes (2)
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.
Measured: 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm feasibility pilot study. All enrolled participants will receive the same 12-week app-delivered resistance training intervention (PLAN-RT 1.0); there is no control or comparison group. This design was selected to first establish feasibility, acceptability, and preliminary outcome signals of the intervention before proceeding to a larger controlled trial. The intervention integrates a smartwatch, resistance band, and smartphone applications to deliver personalized goal setting, action planning, contextual prompts, self-monitoring, and feedback, grounded in Self-Regulation Theory and Habit Formation Theory.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University and A&M College
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana Clinical and Translational Science Center, Pennington Biomedical Research Center
- Responsible party
- Principal investigator, Shiyu Li, PhD, Louisiana State University and A&M College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787533
- Sponsor's protocol ID
- AM260036
- Acronym
- PLAN-RT
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Scalable Digital Resistance Training Intervention to Preserve Muscle Function in Midlife Women Receiving GLP-1 Therapy
- ClinicalTrials.gov ID
- NCT07787533
- Acronym / sponsor ID
- PLAN-RT / AM260036
- Conditions
- Women's Health, Obesity & Overweight, Perimenopausal Women, Digital Intervention, Behavior Change, glp1 Agonist
- Keywords
- resistance training, women's health, obesity, perimenopausal women, digital intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Louisiana State University and A&M CollegeUniversity, hospital or other
- Collaborators
- Louisiana Clinical and Translational Science Center, Pennington Biomedical Research Center
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm feasibility pilot study. All enrolled participants will receive the same 12-week app-delivered resistance training intervention (PLAN-RT 1.0); there is no control or comparison group. This design was selected to first establish feasibility, acceptability, and preliminary outcome signals of the intervention before proceeding to a larger controlled trial. The intervention integrates a smartwatch, resistance band, and smartphone applications to deliver personalized goal setting, action planning, contextual prompts, self-monitoring, and feedback, grounded in Self-Regulation Theory and Habit Formation Theory.
| Arm | Type | Receives |
|---|---|---|
| PLAN-RT 1.0 | Experimental | Behavioral: PLAN-RT 1.0Participants 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. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLAN-RT 1.0A 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. | Behavioural | PLAN-RT 1.0 |
Primary outcome
Number of adults screened (Participants)
Time frame: Weekly throughout recruitment
Number of adults screened for eligibility for the study
Intervention Acceptability (CSQ-8)
Time frame: Week 12
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
Number of Adults Enrolled (Participants)
Time frame: Weekly throughout recruitment
Number of adults who met eligibility criteria and enrolled in the study
Retention Rate (Percentage of enrolled participants)
Time frame: Week 4, 8, 12
Proportion of enrolled participants who completed the 12-week study
2 secondary outcomes
Change in Body Weight in Kilograms
Time frame: Baseline and Week 12
Intervention Usability (SUS)
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLAN-RT 1.0 in people with Women's Health and Obesity & Overweight, run by Louisiana State University and A&M College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyu Li (225-578-0977, sli40@lsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adults screened (Participants) (time frame: Weekly throughout recruitment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.