Digital Resistance Training for Midlife Women Using GLP-1

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-59
SponsorLouisiana State University and A&M College

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: PLAN-RT 1.0Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of adults screened (Participants)

Number of adults screened for eligibility for the study

Time frame
Weekly throughout recruitment
2

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
3

Number of Adults Enrolled (Participants)

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

Time frame
Weekly throughout recruitment
4

Retention Rate (Percentage of enrolled participants)

Proportion of enrolled participants who completed the 12-week study

Time frame
Week 4, 8, 12

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

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Louisiana State University and A&M College

Lead sponsor

Louisiana Clinical and Translational Science Center

Collaborator

Pennington Biomedical Research Center

Collaborator

This trial is not recruiting at the moment. You can still explore other options: