Weight LossBODIESNCT06636305
Investigation of Increased Physical Activity During the Postpartum Period on Weight Loss, Body Composition, and Energy Expenditure
A study testing physical activity intervention in people with Weight Loss and Postpartum, run by Nicolas D. Knuth at 1 site in United States.
Trial summary
The overall goal of this study is to investigate the impact of increased physical activity during the postpartum period on on weight loss, body composition, energy expenditure, and body image perceptions following pregnancy and childbirth. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Postpartum, Physical Activity
- What is being tested?
- physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2017to 13 Dec 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 6-12 weeks postpartum following a live singleton birth.
Who cannot join
- inability to walk without assistance.
- not cleared by their medical provider to resume physical activity by 12 weeks postpartum.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postpartum Behavioral Observation of Diet, Image, and Exercise Study (BODIES)
The overall goal of this study is to investigate the impact of increased physical activity during the postpartum period on on weight loss, body composition, energy expenditure, and body image perceptions following pregnancy and childbirth. Specifically, this study utilizes a mixed methods approach including qualitative and quantitative analyses of the physiological and sociological determinants of postpartum women's health and wellness,
The primary objective of the proposed project is to assess the impact of a physical activity intervention on postpartum women\'s ability to return to pre-pregnancy body weight, the resumption of normal activity and bodily function, and the improvement of body image.
This objective will be achieved via the assessment of quantitative, physiological markers (i.e. physical activity level, body composition, energy expenditure, and hormone levels), as well as qualitative, sociological markers (i.e. self-report and interview data related to body image and bodily recovery) that serve as a measure of a postpartum body that has resumed relatively normal physical function and activity.
Read the detailed description
Postpartum women will be recruited to participate and randomly assigned to a control group or an intervention group. Both groups will follow the data collection protocol described below; however, the intervention group will also be tasked with a self-administered physical activity intervention while the control group will be told to go about their normal routine and engage in whatever activity they would normally do. The intervention group will be asked to meet physical activity benchmarks of 10,000 steps per day and 150 minutes of moderate-to-vigorous physical activity (MVPA) per week (intervention protocol described in more detail below).
All participants will begin the study when they are between 6 weeks and 3 months postpartum and, overall, data will be collect at 4 separate visits, approximately 3 months apart, over the course of 9 months.
Testing to occur at each visit:
Body composition - Total fat mass, lean tissue mass and percentage of body fat will be assessed as participants lie in a supine position using dual-energy x-ray absorptiometry (DXA) (GE Lunar Prodigy, GE Medical Systems, Milwaukee WI).
Vascular Function Test - Indices of vascular function will be obtained in the non-dominant arm using a strain gauge plethsymograph or ultrasound. The testing entails wrapping a rubber band like device (i.e., strain gauge) around the forearm or placing an ultrasound on the skin while the subject is in a supine position. To induce a change in blood flow, a blood pressure cuff is wrapped around the upper portion of the limb (upper arm or thigh) and occluded for 5 minutes. After the 5 minute occlusion the blood pressure cuff is rapidly deflated. The change in the diameter of the strain gauge is used to quantify the change in blood flow and, in turn, the change in vascular function.
Resting energy expenditure (REE) - REE represents the minimum amount of energy the body needs to maintain normal body function and will be measured while fasted by indirect calorimetry over 20-30 minutes while lying down comfortable.
Blood draw - A 15mL blood draw will be made to allow measurement of metabolic substrate (glucose, fatty acids, triglycerides, cholesterol) and inflammation factors (IL-6, IL-1, TNF-a) related to metabolic rate and fatigue.
Blood pressure, height \& weight measurements.
Surveys and monitoring to be administered and/or completed at each visits 1:
Participant Information Form - requires participant to list their name and contact information as well as relevant physician and emergency contact information.
Medical History Form -Measures self-reported general health history. Participants will only complete this form at visit 1.
Pittsburg Sleep Quality Index (PSQI) - a self-rated questionnaire assessment that measures sleep quality and disturbance over a 1-month time interval. Nineteen items generate scores to assess sleep quality, latency and duration.
Demographic Survey - Measures self-reported demographic characteristics of the participants. Participants will only complete this form at visit 1.
Breastfeeding Questionnaire - Asks questions about breastfeeding practices
3-day food record- Allows quantifying and qualifying diet over a 3 day period. Participants will take this form home to complete and return at visits 2, 4, \& 6.
Body Image Quality of Life Inventory (BIQLI) - Self-reported 7-point response format ranging from very negative (-3) to very positive (+3) to assess effects of body image on 19 life domains (including sense of self, social functioning, sexuality, emotional well-being, eating, exercise, grooming, etc.).
Edinburg Postpartum Depression Scale (EDPS) - The EDPS is a self-reported 10-item psychological rating scale for measuring the severity of postnatal depression symptoms. This is a standard scale utilized in clinical settings (OBGYN, Pediatrician, \& specialized clinician visits).
Multidimensional Assessment of Fatigue (MAF) - This is a self-reported 16-item rating scale useful in measuring the experience of fatigue and its relationship to one's ability to execute daily activities and perform tasks/roles.
Daily activity and sleep monitoring (7 consecutive days)- Objective sleep and physical activity data will be collected using wristwatch actigraph technology. The device is worn on the non-dominant arm and provides accurate and reliable activity and sleep time measurements, including; number of steps taken, estimated energy expenditure, amount of sleep, frequency of awakenings and sleep efficiency. This device has been well validated. Participants will be fitted with this device and wear it for 7 consecutive days.
American College of Obstetricians \& Gynecologists (ACOG) Brochure "Exercise after Pregnancy" - This pamphlet explains the benefits of exercise, the latest guidelines for physical activity and details an example of how postpartum women can exercise following pregnancy.
Continuous data collection over nine month period:
Fitbit Data Collection - Participants will be given a Fitbit Charge HR 2 and asked to wear the device for the duration of the study as it will assist them with tracking and achieving step count and MVPA goals. Participants will be asked to consent to share the data the FitBit collects related to daily step count, calories burned, heart rate, and physical activity monitoring. FitBit data will be collected via Fitabase, a research platform that collects data from FitBit devices. The research team will monitor participant FitBit data via Fitabase and send participants assigned to the invertention group weekly text messages regarding their weekly performance. Participants assigned to the control group will not receive weekly feedback regarding their performance.
Specific details of the Intervention Protocol:
The intervention group will be asked to meet physical activity benchmarks of 10,000 steps per day and 150 minutes of MVPA per week (ACOG FAQ Handout entitled "Exercise after pregnancy" will be provided to participants to help define MVPA and provide suggestions for how to engage in physical activity - form attached). MVPA will be defined as physical activity that places heart rate in the range of 120-170 beats per min (bpm) as tracked by the FitBit. Participants will also receive weekly text messages regarding their adherence to the intervention and have access to a brief video that addresses the importance of postpartum physical activity.
- Conditions
- Weight Loss, Postpartum, Physical Activity
- Being tested
- physical activity intervention
- Keywords
- Postpartum, Weight Loss, Physical Activity
- Medical subject headings
- Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity interventionBehavioural
Women in the intervention group were instructed to obtain 10,000 steps per day and 150 minutes of MVPA (defined as physical activity that resulted in a heart rate in the range of 120-170 bmp) per week and were given a physical activity tracker (FitBit Charge HR 2, Fitbit, San Francisco, USA) to self-monitor progress.
| Study group | Role | What they receive |
|---|---|---|
| physical activity intervention | Experimental | Women in the intervention group were instructed to obtain 10,000 steps per day and 150 minutes of MVPA (defined as physical activity that resulted in a heart rate in the range of 120-170 bmp) per week and were given a physical activity tracker (FitBit Charge HR 2, Fitbit, San Francisco, USA) to self-monitor progress. Receives: Behavioral: physical activity intervention |
| control group | No intervention | Women in the control group were given a physical activity tracker (FitBit Charge HR 2, Fitbit, San Francisco, USA) but no other physical activity instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Weight Retention
Postpartum weight retention was calculated as the difference between the participant's postpartum weight at each visit and their self-reported pre-pregnancy weight.
Measured: From enrollment to the end of the study at the 12 month postpartum mark
Secondary outcomes (3)
Postpartum Resting Energy Expenditure
Resting energy expenditure (REE) was measured in supine position for 20 minutes by indirect calorimetry following a >8h fast. REE was calculated from the average rate of oxygen consumption and carbon dioxide production over the last 15 minutes of the test.
Measured: REE was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.
Postpartum Body Composition
Body composition (i.e., fat mass (kg) and fat-free-mass (kg)) was measured by dual energy x-ray absorptiometry. In instances where participants supine body width exceeded the dimensions of the scan window, the analysis of the scans utilized the MirrorImage application.
Measured: Postpartum body composition was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.
Postpartum Sleep Quality
The Pittsburg Sleep Quality Index (PSQI) was used to assess sleep quality over the past month at each visit. The PSQI is a 19-item self-report questionnaire indexing seven clinically formulated sleep domains: subjective sleep quality, sleep latency, sleep duration, sleep duration, habitual sleep efficiency, sleep disturbances, and use of sleep medications. Scores on each of the seven PSQI subscales were used to calculate a global score ranging from 0 to 21, with higher score reflecting poorer sleep quality.
Measured: Postpartum sleep quality was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start17 Oct 2017
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One groups will be assigned to a physical activity intervention, the other group will serve as a control group.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolas D. Knuth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicolas D. Knuth, Towson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636305
- Sponsor's protocol ID
- 1707021250
- Acronym
- BODIES
- Status last verified
- Sep 2024
- First submitted
- 4 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Behavioral Observation of Diet, Image, and Exercise Study (BODIES)
- ClinicalTrials.gov ID
- NCT06636305
- Acronym / sponsor ID
- BODIES / 1707021250
- Conditions
- Weight Loss, Postpartum, Physical Activity
- Keywords
- Postpartum, Weight Loss, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nicolas D. KnuthUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 10 Oct 2024 (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 overall goal of this study is to investigate the impact of increased physical activity during the postpartum period on on weight loss, body composition, energy expenditure, and body image perceptions following pregnancy and childbirth. Specifically, this study utilizes a mixed methods approach including qualitative and quantitative analyses of the physiological and sociological determinants of postpartum women's health and wellness,
The primary objective of the proposed project is to assess the impact of a physical activity intervention on postpartum women\'s ability to return to pre-pregnancy body weight, the resumption of normal activity and bodily function, and the improvement of body image.
This objective will be achieved via the assessment of quantitative, physiological markers (i.e. physical activity level, body composition, energy expenditure, and hormone levels), as well as qualitative, sociological markers (i.e. self-report and interview data related to body image and bodily recovery) that serve as a measure of a postpartum body that has resumed relatively normal physical function and activity.
Detailed description
Postpartum women will be recruited to participate and randomly assigned to a control group or an intervention group. Both groups will follow the data collection protocol described below; however, the intervention group will also be tasked with a self-administered physical activity intervention while the control group will be told to go about their normal routine and engage in whatever activity they would normally do. The intervention group will be asked to meet physical activity benchmarks of 10,000 steps per day and 150 minutes of moderate-to-vigorous physical activity (MVPA) per week (intervention protocol described in more detail below).
All participants will begin the study when they are between 6 weeks and 3 months postpartum and, overall, data will be collect at 4 separate visits, approximately 3 months apart, over the course of 9 months.
Testing to occur at each visit:
Body composition - Total fat mass, lean tissue mass and percentage of body fat will be assessed as participants lie in a supine position using dual-energy x-ray absorptiometry (DXA) (GE Lunar Prodigy, GE Medical Systems, Milwaukee WI).
Vascular Function Test - Indices of vascular function will be obtained in the non-dominant arm using a strain gauge plethsymograph or ultrasound. The testing entails wrapping a rubber band like device (i.e., strain gauge) around the forearm or placing an ultrasound on the skin while the subject is in a supine position. To induce a change in blood flow, a blood pressure cuff is wrapped around the upper portion of the limb (upper arm or thigh) and occluded for 5 minutes. After the 5 minute occlusion the blood pressure cuff is rapidly deflated. The change in the diameter of the strain gauge is used to quantify the change in blood flow and, in turn, the change in vascular function.
Resting energy expenditure (REE) - REE represents the minimum amount of energy the body needs to maintain normal body function and will be measured while fasted by indirect calorimetry over 20-30 minutes while lying down comfortable.
Blood draw - A 15mL blood draw will be made to allow measurement of metabolic substrate (glucose, fatty acids, triglycerides, cholesterol) and inflammation factors (IL-6, IL-1, TNF-a) related to metabolic rate and fatigue.
Blood pressure, height \& weight measurements.
Surveys and monitoring to be administered and/or completed at each visits 1:
Participant Information Form - requires participant to list their name and contact information as well as relevant physician and emergency contact information.
Medical History Form -Measures self-reported general health history. Participants will only complete this form at visit 1.
Pittsburg Sleep Quality Index (PSQI) - a self-rated questionnaire assessment that measures sleep quality and disturbance over a 1-month time interval. Nineteen items generate scores to assess sleep quality, latency and duration.
Demographic Survey - Measures self-reported demographic characteristics of the participants. Participants will only complete this form at visit 1.
Breastfeeding Questionnaire - Asks questions about breastfeeding practices
3-day food record- Allows quantifying and qualifying diet over a 3 day period. Participants will take this form home to complete and return at visits 2, 4, \& 6.
Body Image Quality of Life Inventory (BIQLI) - Self-reported 7-point response format ranging from very negative (-3) to very positive (+3) to assess effects of body image on 19 life domains (including sense of self, social functioning, sexuality, emotional well-being, eating, exercise, grooming, etc.).
Edinburg Postpartum Depression Scale (EDPS) - The EDPS is a self-reported 10-item psychological rating scale for measuring the severity of postnatal depression symptoms. This is a standard scale utilized in clinical settings (OBGYN, Pediatrician, \& specialized clinician visits).
Multidimensional Assessment of Fatigue (MAF) - This is a self-reported 16-item rating scale useful in measuring the experience of fatigue and its relationship to one's ability to execute daily activities and perform tasks/roles.
Daily activity and sleep monitoring (7 consecutive days)- Objective sleep and physical activity data will be collected using wristwatch actigraph technology. The device is worn on the non-dominant arm and provides accurate and reliable activity and sleep time measurements, including; number of steps taken, estimated energy expenditure, amount of sleep, frequency of awakenings and sleep efficiency. This device has been well validated. Participants will be fitted with this device and wear it for 7 consecutive days.
American College of Obstetricians \& Gynecologists (ACOG) Brochure "Exercise after Pregnancy" - This pamphlet explains the benefits of exercise, the latest guidelines for physical activity and details an example of how postpartum women can exercise following pregnancy.
Continuous data collection over nine month period:
Fitbit Data Collection - Participants will be given a Fitbit Charge HR 2 and asked to wear the device for the duration of the study as it will assist them with tracking and achieving step count and MVPA goals. Participants will be asked to consent to share the data the FitBit collects related to daily step count, calories burned, heart rate, and physical activity monitoring. FitBit data will be collected via Fitabase, a research platform that collects data from FitBit devices. The research team will monitor participant FitBit data via Fitabase and send participants assigned to the invertention group weekly text messages regarding their weekly performance. Participants assigned to the control group will not receive weekly feedback regarding their performance.
Specific details of the Intervention Protocol:
The intervention group will be asked to meet physical activity benchmarks of 10,000 steps per day and 150 minutes of MVPA per week (ACOG FAQ Handout entitled "Exercise after pregnancy" will be provided to participants to help define MVPA and provide suggestions for how to engage in physical activity - form attached). MVPA will be defined as physical activity that places heart rate in the range of 120-170 beats per min (bpm) as tracked by the FitBit. Participants will also receive weekly text messages regarding their adherence to the intervention and have access to a brief video that addresses the importance of postpartum physical activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One groups will be assigned to a physical activity intervention, the other group will serve as a control group.
| Arm | Type | Receives |
|---|---|---|
| physical activity intervention | Experimental | Behavioral: physical activity interventionWomen in the intervention group were instructed to obtain 10,000 steps per day and 150 minutes of MVPA (defined as physical activity that resulted in a heart rate in the range of 120-170 bmp) per week and were given a physical activity tracker (FitBit Charge HR 2, Fitbit, San Francisco, USA) to self-monitor progress. |
| control group | No intervention | –Women in the control group were given a physical activity tracker (FitBit Charge HR 2, Fitbit, San Francisco, USA) but no other physical activity instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- between 6-12 weeks postpartum following a live singleton birth.
Key exclusion criteria (2 listed)
- inability to walk without assistance.
- not cleared by their medical provider to resume physical activity by 12 weeks postpartum.
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 |
|---|---|---|
| physical activity interventionWomen in the intervention group were instructed to obtain 10,000 steps per day and 150 minutes of MVPA (defined as physical activity that resulted in a heart rate in the range of 120-170 bmp) per week and were given a physical activity tracker (FitBit Charge HR 2, Fitbit, San Francisco, USA) to self-monitor progress. | Behavioural | physical activity intervention |
Primary outcome
Postpartum Weight Retention
Time frame: From enrollment to the end of the study at the 12 month postpartum mark
Postpartum weight retention was calculated as the difference between the participant's postpartum weight at each visit and their self-reported pre-pregnancy weight.
3 secondary outcomes
Postpartum Resting Energy Expenditure
Time frame: REE was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.
Postpartum Body Composition
Time frame: Postpartum body composition was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.
Postpartum Sleep Quality
Time frame: Postpartum sleep quality was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.
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 10 Oct 2024.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request.
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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 physical activity intervention in people with Weight Loss and Postpartum, run by Nicolas D. Knuth 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 2 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 10 Oct 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?
Postpartum Weight Retention (time frame: From enrollment to the end of the study at the 12 month postpartum mark). 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 10 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.