Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636305
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Investigation of Increased Physical Activity During the Postpartum Period on Weight Loss Body Composition and Energy Expenditure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Postpartum Behavioral Observation of Diet Image and Exercise Study BODIES
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BODIES
Brief 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 Specifically this study utilizes a mixed methods approach including qualitative and quantitative analyses of the physiological and sociological determinants of postpartum womens health and wellness
The primary objective of the proposed project is to assess the impact of a physical activity intervention on postpartum women39s 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 ie physical activity level body composition energy expenditure and hormone levels as well as qualitative sociological markers ie 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
The primary objective of the proposed project is to assess the impact of a physical activity intervention on postpartum women39s 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 ie physical activity level body composition energy expenditure and hormone levels as well as qualitative sociological markers ie 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 10000 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 ie 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 amp weight measurements
Surveys and monitoring to be administered andor 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 amp 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 amp 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 ones ability to execute daily activities and perform tasksroles
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 amp 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 10000 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
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 ie 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 amp weight measurements
Surveys and monitoring to be administered andor 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 amp 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 amp 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 ones ability to execute daily activities and perform tasksroles
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 amp 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 10000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None