Body Image DisturbanceNCT04038463
Effects of Resistance Training in Body Composition and Body Image Perception of Women Throughout the Menstrual Cycle
A study testing EFP, LFP and ELP in people with Body Image Disturbance, run by Southern Illinois University Edwardsville at 1 site in United States.
Trial summary
The objective of this research study is two-fold, 1) to determine if body composition and body image perception are affected through the different phases of the menstrual cycle, and 2) if an acute session of resistance training can have different effects depending on the menstrual cycle phase. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image Disturbance
- What is being tested?
- EFP, LFP and ELP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 16 Mar 2020
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Sedentary or Active
- 18.5-34.9 kg/m2 BMI
- Normal menstrual cycle defined as 28 to 30 days and a duration of 3 to 7 days
- Age range is 18-45 years old
- The inclusion of other participants may alter the results as an increase in body fat has been linked to known changes in different hormonal levels and those changes might influence substrate utilization
- Changes in the hormonal status of pre-menopausal women may appear without symptoms
- Younger females also display variations in their hormones since they are going through the process of development
Who cannot join
- Previous physiological and mental health history
- Pregnant females
- Males
- Irregular menstrual cycle, menstrual dysfunction or unusual sex hormone levels
- Musculoskeletal injuries
- Contraceptives, a medication that alters hormonal or cardio-respiratory responses
- Pre-menopausal symptoms
- On moderate to high-intensity exercise regime more than 2 days/week
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University Edwardsville
Edwardsville, Illinois, 62026
About this study
The objective of this research study is two-fold, 1) to determine if body composition and body image perception are affected through the different phases of the menstrual cycle, and 2) if an acute session of resistance training can have different effects depending on the menstrual cycle phase.
Read the detailed description
The purpose of the research is to establish whether body composition and body image perception are affected throughout the different phases of the menstrual cycle and if the perception can be modified through resistance training. To the best of our knowledge, only one study has analyzed the effects of the menstrual cycle on body image perception. However, research analyzing the effects of the menstrual cycle on both body image perception and, body composition is lacking. Furthermore, research in the effects of resistance training on menstrual cycle-related changes on both perceived and measured body composition are inexistent. Findings from this study have the potential to increase the knowledge about resistance training's effects in modulating body image perception throughout the menstrual cycle. Further understanding of these responses may set the groundwork to develop exercise intervention programs to reduce the risk of developing more serious mental conditions linked to unhealthy body image perception.
- Conditions
- Body Image Disturbance
- Being tested
- EFP, LFP, ELP, LLP
- Keywords
- Menstrual Cycle, Resistance Training, Body Composition, Intervention, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFPBehavioural
This intervention will take place on day 4 of the participants' menstrual cycle. This will correspond to the mid-point of the early follicular phase (EFP).
LFPBehavioural
The intervention will take place on day 8 of the participants' menstrual cycle. This will correspond to the mid-point of the late follicular phase (LFP).
ELPBehavioural
The intervention will take place on day 18 of the participants' menstrual cycle. This will correspond to the mid-point of the early luteal phase (ELP).
LLPBehavioural
The intervention will take place on day 25 of the participants' menstrual cycle. This will correspond to the mid-point of the late luteal phase (LLP).
| Study group | Role | What they receive |
|---|---|---|
| Early Follicular Phase (EFP) | Experimental | The group will engage in the Resistance Training intervention on the fourth day of their menstrual cycle, which will correlate with the middle of the early follicular phase (EFP). Receives: Behavioral: EFP |
| Late Follicular Phase (LFP) | Experimental | The group will engage in the Resistance Training intervention on the eleventh day of their menstrual cycle, which will correlate with the middle of the late follicular phase (LFP). Receives: Behavioral: LFP |
| Early Luteal Phase (ELP) | Experimental | The group will engage in the Resistance Training intervention on the eighteenth of their menstrual cycle, which will correlate with the middle of the early luteal phase (ELP). Receives: Behavioral: ELP |
| Late Luteal Phase (LLP) | Experimental | The group will engage in the Resistance Training intervention on the twenty-fifth day of their menstrual cycle, which will correlate with the middle of the late luteal phase (LLP). Receives: Behavioral: LLP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Image Perception through questionnaire
Participants will be distributed the Multidimensional Body-Self Relations Questionnaire-Appearance Scale (MBSRQ-AS) to measure their body image perceptions.
Measured: Through study completion: an average of 1 month
Body Image Perception through drawing scale
Participants will be distributed the Contour Drawing Rating Scale to measure their body image perception.
Measured: Through study completion: an average of 1 month
Barriers to Weight Control
Participants will be distributed the Survey of Barriers to Weight Control to measure their body image perception.
Measured: Through study completion: an average of 1 month
Fat Mass in Kilograms
We will measure fat mass using the Dual-Energy Xray Absorptiometry (DXA)
Measured: Through study completion: an average of 1 month
Lean Body Mass in Kilograms
We will measure lean body mass using the Dual-Energy Xray Absorptiometry (DXA)
Measured: Through study completion: an average of 1 month
Relative Body Fat
We will measure relative body fat (percentage) using the Dual-Energy Xray Absorptiometry (DXA)
Measured: Through study completion: an average of 1 month
Secondary outcomes (5)
Bench Press One Repetition Maximum
Participants muscular strength will be assessed by a one-repetition (1RM) on bench press
Measured: At baseline: 1 assessment point prior randomization
Leg Press One Repetition Maximum
Participants lower body muscular strength will be assessed by a one-repetition (1RM) on leg press
Measured: At baseline: 1 assessment point prior randomization
Dietary habits
The participants diet will be recorded using the ASA-24h recall
Measured: Before each exercise session: 1 assessment point on each menstrual cycle phase
Estrogen (Estradiol) levels
Blood will be drawn from the participants for assessment of the estrogen hormone
Measured: Before each exercise session: 1 assessment point on each menstrual cycle phase
Progesterone levels
Blood will be drawn from the participants for assessment of the progesterone hormone
Measured: Before each exercise session: 1 assessment point on each menstrual cycle phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Sep 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Image DisturbanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University Edwardsville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Fernandez del Valle, PhD, Principal investigator, Southern Illinois University Edwardsville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038463
- Sponsor's protocol ID
- 160
- Status last verified
- Jul 2019
- First submitted
- 21 May 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training in Body Composition and Body Image Perception of Women Throughout the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT04038463
- Acronym / sponsor ID
- 160
- Conditions
- Body Image Disturbance
- Keywords
- Menstrual Cycle, Resistance Training, Body Composition, Intervention, Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pandemic
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Southern Illinois University EdwardsvilleUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 30 Jul 2019 (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 objective of this research study is two-fold, 1) to determine if body composition and body image perception are affected through the different phases of the menstrual cycle, and 2) if an acute session of resistance training can have different effects depending on the menstrual cycle phase.
Detailed description
The purpose of the research is to establish whether body composition and body image perception are affected throughout the different phases of the menstrual cycle and if the perception can be modified through resistance training. To the best of our knowledge, only one study has analyzed the effects of the menstrual cycle on body image perception. However, research analyzing the effects of the menstrual cycle on both body image perception and, body composition is lacking. Furthermore, research in the effects of resistance training on menstrual cycle-related changes on both perceived and measured body composition are inexistent. Findings from this study have the potential to increase the knowledge about resistance training's effects in modulating body image perception throughout the menstrual cycle. Further understanding of these responses may set the groundwork to develop exercise intervention programs to reduce the risk of developing more serious mental conditions linked to unhealthy body image perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early Follicular Phase (EFP) | Experimental | Behavioral: EFPThe group will engage in the Resistance Training intervention on the fourth day of their menstrual cycle, which will correlate with the middle of the early follicular phase (EFP). |
| Late Follicular Phase (LFP) | Experimental | Behavioral: LFPThe group will engage in the Resistance Training intervention on the eleventh day of their menstrual cycle, which will correlate with the middle of the late follicular phase (LFP). |
| Early Luteal Phase (ELP) | Experimental | Behavioral: ELPThe group will engage in the Resistance Training intervention on the eighteenth of their menstrual cycle, which will correlate with the middle of the early luteal phase (ELP). |
| Late Luteal Phase (LLP) | Experimental | Behavioral: LLPThe group will engage in the Resistance Training intervention on the twenty-fifth day of their menstrual cycle, which will correlate with the middle of the late luteal phase (LLP). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female
- Sedentary or Active
- 18.5-34.9 kg/m2 BMI
- Normal menstrual cycle defined as 28 to 30 days and a duration of 3 to 7 days
- Age range is 18-45 years old
Key exclusion criteria (8 listed)
- Previous physiological and mental health history
- Pregnant females
- Males
- Irregular menstrual cycle, menstrual dysfunction or unusual sex hormone levels
- Musculoskeletal injuries
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 |
|---|---|---|
| EFPThis intervention will take place on day 4 of the participants' menstrual cycle. This will correspond to the mid-point of the early follicular phase (EFP). | Behavioural | Early Follicular Phase (EFP) |
| LFPThe intervention will take place on day 8 of the participants' menstrual cycle. This will correspond to the mid-point of the late follicular phase (LFP). | Behavioural | Late Follicular Phase (LFP) |
| ELPThe intervention will take place on day 18 of the participants' menstrual cycle. This will correspond to the mid-point of the early luteal phase (ELP). | Behavioural | Early Luteal Phase (ELP) |
| LLPThe intervention will take place on day 25 of the participants' menstrual cycle. This will correspond to the mid-point of the late luteal phase (LLP). | Behavioural | Late Luteal Phase (LLP) |
Primary outcome
Body Image Perception through questionnaire
Time frame: Through study completion: an average of 1 month
Participants will be distributed the Multidimensional Body-Self Relations Questionnaire-Appearance Scale (MBSRQ-AS) to measure their body image perceptions.
Body Image Perception through drawing scale
Time frame: Through study completion: an average of 1 month
Participants will be distributed the Contour Drawing Rating Scale to measure their body image perception.
Barriers to Weight Control
Time frame: Through study completion: an average of 1 month
Participants will be distributed the Survey of Barriers to Weight Control to measure their body image perception.
Fat Mass in Kilograms
Time frame: Through study completion: an average of 1 month
We will measure fat mass using the Dual-Energy Xray Absorptiometry (DXA)
Lean Body Mass in Kilograms
Time frame: Through study completion: an average of 1 month
We will measure lean body mass using the Dual-Energy Xray Absorptiometry (DXA)
Relative Body Fat
Time frame: Through study completion: an average of 1 month
We will measure relative body fat (percentage) using the Dual-Energy Xray Absorptiometry (DXA)
5 secondary outcomes
Bench Press One Repetition Maximum
Time frame: At baseline: 1 assessment point prior randomization
Leg Press One Repetition Maximum
Time frame: At baseline: 1 assessment point prior randomization
Dietary habits
Time frame: Before each exercise session: 1 assessment point on each menstrual cycle phase
Estrogen (Estradiol) levels
Time frame: Before each exercise session: 1 assessment point on each menstrual cycle phase
Progesterone levels
Time frame: Before each exercise session: 1 assessment point on each menstrual cycle phase
Results and safety
The study was stopped early (reason given: Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
Maria Fernandez del Valle, PhD principal investigator
Southern Illinois University Edwardsville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFP, LFP and ELP in people with Body Image Disturbance, run by Southern Illinois University Edwardsville 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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Oct 2021. 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 was stopped early (reason given: Pandemic). Results are not available in the source record.
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?
Body Image Perception through questionnaire (time frame: Through study completion: an average of 1 month). The study lists 6 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 4 Oct 2021.