Digital Resistance Training for Midlife Women Using GLP-1

NCT07787533 | Not Yet Recruiting

• 1 other identifier: AM260036
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Women's Health; Obesity & Overweight; Perimenopausal Women; Digital Intervention; Behavior Change; glp1 Agonist; Resistance Exercise

Keywords

resistance training; women's health; obesity; perimenopausal women; digital intervention

Outcome Measures

Primary Outcomes (4)

• Number of adults screened (Participants)

  Number of adults screened for eligibility for the study

  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

  Week 12

• Number of Adults Enrolled (Participants)

  Number of adults who met eligibility criteria and enrolled in the study

  Weekly throughout recruitment

• Retention Rate (Percentage of enrolled participants)

  Proportion of enrolled participants who completed the 12-week study

  Week 4, 8, 12

Secondary Outcomes (2)

• Change in Body Weight in Kilograms

  Baseline and Week 12

• Intervention Usability (SUS)

  Week 12

Study Arms (1)

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.

Behavioral: PLAN-RT 1.0

Interventions

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.

PLAN-RT 1.0

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University and A&M College: lead
• Louisiana Clinical and Translational Science Center: collaborator
• Pennington Biomedical Research Center: collaborator

Study Sites (1)

Louisiana State University School of Kinesiology

Baton Rouge, Louisiana, 70803, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shiyu Li

CONTACT

225-578-0977; sli40@lsu.edu

Kimberly Allen

CONTACT

225-578-2363; kmallen@lsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)