Physical InactivityNCT05426070
Preliminary Efficacy of a Strength Training Intervention on Exercise Adherence and Weight Among Pre-Menopausal Women
A study testing Strength training-based exercise in people with Physical Inactivity and Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility and acceptability of a strength training-based intervention on exercise adherence among low active (defined as engaging in physical activity 90 minutes or less per week), pre-menopausal women ages 40-50, along with the effect on weight and various psychosocial… Read more about this study
- Who is it for?
- Ages 40 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Obesity
- What is being tested?
- Strength training-based exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2022to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) pre-menopausal women ages 40-50 years; (2) engaging in 90 minutes or less of exercise per week; (3) no exercise contraindications; (4) adequate space at home to complete exercise sessions and capacity to use Zoom via a mobile device or computer; (5) available to attend two zoom-based sessions a week; (6) be able to read, understand, and speak in the English language (7) willing to be randomly assigned to either study condition (8) access to iPhone 8 or later with iOS 16 or later
Who cannot join
- Specific exclusion criteria will include a history of coronary heart disease (history of myocardial infarction, symptoms of angina), orthopedic problems that would limit physical activity participation, diabetes, stroke, osteoarthritis, and any other medical condition that may make physical activity unsafe or unwise. Other exclusion criteria will include current or planned pregnancy, psychosis or current suicidal ideation, and psychiatric hospitalization within the last six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The purpose of this study is to examine the feasibility and acceptability of a strength training-based intervention on exercise adherence among low active (defined as engaging in physical activity 90 minutes or less per week), pre-menopausal women ages 40-50, along with the effect on weight and various psychosocial measures. Participants will be randomly assigned to a strength training-based intervention or a wait-list control each lasting three months (participants in the no contact, wait-list control condition will have the option of receiving the strength training-based intervention following the three months).
Read the detailed description
Participants will be randomly assigned to a strength training-based exercise intervention or a no contact, wait-list control each lasting three months (participants in the no contact, wait-list control will have the option of receiving the strength training-based intervention following the three months). The strength training-based exercise intervention will be delivered via group-based Zoom sessions, motivational email messages, and a website. Participants will take part in two group-based Zoom exercise sessions (40-minute exercise sessions and 20 minutes of motivational counseling) and two individual exercise sessions per week for six months. Exercise sessions will include a combination of various aerobic (e.g., jogging in place, high knees) and muscle strengthening exercises (e.g., burpees, push-ups, lunges, body weight squats) designed to keep heart rate in the 60-85% range of maximum heart rate. Participants will choose from a variety of options for their two individual sessions (e.g., online exercise video, jogging or walking outside, prescribed exercise session listed on the website, or any other exercise) and modifications for each exercise will be made depending on the participant's ability and current fitness and strength level (e.g., wall push-ups vs. knee push-ups vs. regular push-ups). Participants will be instructed to stop exercising if problems occur and will receive training and handouts on how to recognize problems such as angina and myocardial infarction symptoms.
Self-Determination Theory (SDT) and habit formation theory will guide the content of the counseling portion of the Zoom sessions and the motivational features of the study website and text messages. Motivational counseling will be focused on increasing motivation to exercise and habit formation. The goal is to achieve integrated regulation and therefore, the health counselor will focus on positive affective response to exercise sessions and discuss how being physically active is becoming part of their self-identity. The goal will be high intrinsic motivation (i.e., individuals engage in exercise due to inherent pleasure) since it is related to higher levels of exercise. Strength training-based participants will also receive access to a mobile phone-friendly study website and will receive emails. Both the website and email messages will contain motivational content to complete the exercise sessions. The motivational website will also include an online log to track completion of home-based sessions and options for individual-based exercise sessions.. Assessment of exercise adherence, weight, and psychosocial variables will occur at baseline and three months.
- Conditions
- Physical Inactivity, Obesity
- Being tested
- Strength training-based exercise
- Keywords
- strength training, group-based exercise, pre-menopausal, exercise adherence
- Medical subject headings
- Sedentary Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training-based exerciseBehavioural
Participants will take part in two group-based Zoom exercise sessions and two individual exercise sessions per week for three months. Exercise sessions will include a combination of various aerobic (e.g., jogging in place, high knees) and muscle strengthening exercises (e.g., burpees, push-ups, lunges, body weight squats) designed to keep heart rate in the 60-85% range of maximum heart rate. Participants will choose from a variety of options for their two individual sessions (e.g., online exercise video, jogging or walking outside, prescribed exercise session listed on the website, or any other exercise) and modifications for each exercise will be made depending on the participant's ability and current fitness and strength level. Participants will be instructed to stop exercising if problems occur and will receive training and handouts on how to recognize problems such as angina and myocardial infarction.
| Study group | Role | What they receive |
|---|---|---|
| Strength training-based exercise | Experimental | The strength training-based exercise intervention will be delivered via group-based Zoom sessions, motivational text messages, and a website. Participants will take part in two group-based Zoom exercise sessions (40-minute exercise sessions and 20 minutes of motivational counseling) and two individual exercise sessions per week for three months. Exercise sessions will include a combination of various aerobic and muscle strengthening exercises designed to keep heart rate in the 60-85% range of maximum heart rate. Motivational counseling will be focused on increasing motivation to exercise and habit formation. Strength training-based participants will also receive access to a mobile phone-friendly study website and will receive email messages. Both the website and email messages will contain motivational content to complete the exercise sessions. Receives: Behavioral: Strength training-based exercise |
| No contact, wait-list control | No intervention | Participants in the no contact, wait-list control intervention will participate in assessments at baseline and three months. Following the six month assessment, participants will have the option of receiving the strength training-based intervention as described above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Adherence
Apple Watch
Measured: from date of randomization until the date of three month assessment; up to three months
Secondary outcomes (1)
Weight
Withings Smart Scale
Measured: from date of randomization until the date of three month assessment; up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start30 Dec 2022
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426070
- Sponsor's protocol ID
- 580913
- Status last verified
- Jan 2024
- First submitted
- 15 Jun 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryan, R. M., & Deci, E. L. (2002). Overview of self-determination theory: An organismic dialectical perspective. Handbook of Self-determination Research, 2, 3-33.
Lally P, Wardle J, Gardner B. Experiences of habit formation: a qualitative study. Psychol Health Med. 2011 Aug;16(4):484-9. doi: 10.1080/13548506.2011.555774.
PubMed 21749245Thogersen-Ntoumani C, Shepherd SO, Ntoumanis N, Wagenmakers AJ, Shaw CS. Intrinsic motivation in two exercise interventions: Associations with fitness and body composition. Health Psychol. 2016 Feb;35(2):195-8. doi: 10.1037/hea0000260. Epub 2015 Sep 21.
PubMed 26389719Lewis BA, Schuver KJ, Swinney KB, Dregney TM, Linde JA. Examining the feasibility and preliminary efficacy of a group-based physical activity intervention integrating strength training among pre- and perimenopausal women: A randomized pilot trial. Womens Health (Lond). 2025 Jan-Dec;21:17455057251361243. doi: 10.1177/17455057251361243. Epub 2025 Aug 10.
PubMed 40784014
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy of a Strength Training Intervention on Exercise Adherence and Weight Among Pre-Menopausal Women
- ClinicalTrials.gov ID
- NCT05426070
- Acronym / sponsor ID
- 580913
- Conditions
- Physical Inactivity, Obesity
- Keywords
- strength training, group-based exercise, pre-menopausal, exercise adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 21 Jun 2022 (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 purpose of this study is to examine the feasibility and acceptability of a strength training-based intervention on exercise adherence among low active (defined as engaging in physical activity 90 minutes or less per week), pre-menopausal women ages 40-50, along with the effect on weight and various psychosocial measures. Participants will be randomly assigned to a strength training-based intervention or a wait-list control each lasting three months (participants in the no contact, wait-list control condition will have the option of receiving the strength training-based intervention following the three months).
Detailed description
Participants will be randomly assigned to a strength training-based exercise intervention or a no contact, wait-list control each lasting three months (participants in the no contact, wait-list control will have the option of receiving the strength training-based intervention following the three months). The strength training-based exercise intervention will be delivered via group-based Zoom sessions, motivational email messages, and a website. Participants will take part in two group-based Zoom exercise sessions (40-minute exercise sessions and 20 minutes of motivational counseling) and two individual exercise sessions per week for six months. Exercise sessions will include a combination of various aerobic (e.g., jogging in place, high knees) and muscle strengthening exercises (e.g., burpees, push-ups, lunges, body weight squats) designed to keep heart rate in the 60-85% range of maximum heart rate. Participants will choose from a variety of options for their two individual sessions (e.g., online exercise video, jogging or walking outside, prescribed exercise session listed on the website, or any other exercise) and modifications for each exercise will be made depending on the participant's ability and current fitness and strength level (e.g., wall push-ups vs. knee push-ups vs. regular push-ups). Participants will be instructed to stop exercising if problems occur and will receive training and handouts on how to recognize problems such as angina and myocardial infarction symptoms.
Self-Determination Theory (SDT) and habit formation theory will guide the content of the counseling portion of the Zoom sessions and the motivational features of the study website and text messages. Motivational counseling will be focused on increasing motivation to exercise and habit formation. The goal is to achieve integrated regulation and therefore, the health counselor will focus on positive affective response to exercise sessions and discuss how being physically active is becoming part of their self-identity. The goal will be high intrinsic motivation (i.e., individuals engage in exercise due to inherent pleasure) since it is related to higher levels of exercise. Strength training-based participants will also receive access to a mobile phone-friendly study website and will receive emails. Both the website and email messages will contain motivational content to complete the exercise sessions. The motivational website will also include an online log to track completion of home-based sessions and options for individual-based exercise sessions.. Assessment of exercise adherence, weight, and psychosocial variables will occur at baseline and three months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training-based exercise | Experimental | Behavioral: Strength training-based exerciseThe strength training-based exercise intervention will be delivered via group-based Zoom sessions, motivational text messages, and a website. Participants will take part in two group-based Zoom exercise sessions (40-minute exercise sessions and 20 minutes of motivational counseling) and two individual exercise sessions per week for three months. Exercise sessions will include a combination of various aerobic and muscle strengthening exercises designed to keep heart rate in the 60-85% range of maximum heart rate. Motivational counseling will be focused on increasing motivation to exercise and habit formation. Strength training-based participants will also receive access to a mobile phone-friendly study website and will receive email messages. Both the website and email messages will contain motivational content to complete the exercise sessions. |
| No contact, wait-list control | No intervention | –Participants in the no contact, wait-list control intervention will participate in assessments at baseline and three months. Following the six month assessment, participants will have the option of receiving the strength training-based intervention as described above. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) pre-menopausal women ages 40-50 years; (2) engaging in 90 minutes or less of exercise per week; (3) no exercise contraindications; (4) adequate space at home to complete exercise sessions and capacity to use Zoom via a mobile device or computer; (5) available to attend two zoom-based sessions a week; (6) be able to read, understand, and speak in the English language (7) willing to be randomly assigned to either study condition (8) access to iPhone 8 or later with iOS 16 or later
Key exclusion criteria (1 listed)
- Specific exclusion criteria will include a history of coronary heart disease (history of myocardial infarction, symptoms of angina), orthopedic problems that would limit physical activity participation, diabetes, stroke, osteoarthritis, and any other medical condition that may make physical activity unsafe or unwise. Other exclusion criteria will include current or planned pregnancy, psychosis or current suicidal ideation, and psychiatric hospitalization within the last six months.
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 |
|---|---|---|
| Strength training-based exerciseParticipants will take part in two group-based Zoom exercise sessions and two individual exercise sessions per week for three months. Exercise sessions will include a combination of various aerobic (e.g., jogging in place, high knees) and muscle strengthening exercises (e.g., burpees, push-ups, lunges, body weight squats) designed to keep heart rate in the 60-85% range of maximum heart rate. Participants will choose from a variety of options for their two individual sessions (e.g., online exercise video, jogging or walking outside, prescribed exercise session listed on the website, or any other exercise) and modifications for each exercise will be made depending on the participant's ability and current fitness and strength level. Participants will be instructed to stop exercising if problems occur and will receive training and handouts on how to recognize problems such as angina and myocardial infarction. | Behavioural | Strength training-based exercise |
Primary outcome
Exercise Adherence
Time frame: from date of randomization until the date of three month assessment; up to three months
Apple Watch
1 secondary outcome
Weight
Time frame: from date of randomization until the date of three month assessment; up to three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- BackgroundRyan, R. M., & Deci, E. L. (2002). Overview of self-determination theory: An organismic dialectical perspective. Handbook of Self-determination Research, 2, 3-33.
- Background: PubMed 21749245Lally P, Wardle J, Gardner B. Experiences of habit formation: a qualitative study. Psychol Health Med. 2011 Aug;16(4):484-9. doi: 10.1080/13548506.2011.555774.
- Background: PubMed 26389719Thogersen-Ntoumani C, Shepherd SO, Ntoumanis N, Wagenmakers AJ, Shaw CS. Intrinsic motivation in two exercise interventions: Associations with fitness and body composition. Health Psychol. 2016 Feb;35(2):195-8. doi: 10.1037/hea0000260. Epub 2015 Sep 21.
- Derived from this study: PubMed 40784014Lewis BA, Schuver KJ, Swinney KB, Dregney TM, Linde JA. Examining the feasibility and preliminary efficacy of a group-based physical activity intervention integrating strength training among pre- and perimenopausal women: A randomized pilot trial. Womens Health (Lond). 2025 Jan-Dec;21:17455057251361243. doi: 10.1177/17455057251361243. Epub 2025 Aug 10.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training-based exercise in people with Physical Inactivity and Obesity, run by University of Minnesota 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Adherence (time frame: from date of randomization until the date of three month assessment; up to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426070, which also lists 4 linked publications.
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 8 Jan 2024.