GDMLifestyleNCT05355038
Effect of Lifestyle Modification on Pregnancy Outcome for GDM
A study testing lifestyle modification (dietary modification), lifestyle modification (physical activity) and lifestyle modification( self glucose monitoring) in people with GDM and Lifestyle, run by Cairo University at 1 site in Egypt.
Trial summary
Effect of lifestyle modification on pregnancy outcome for pregnant women with GDM Read more about this study
- Who is it for?
- Ages 19 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GDM, Lifestyle, Pregnancy Outcome
- What is being tested?
- lifestyle modification (dietary modification), lifestyle modification (physical activity) and lifestyle modification( self glucose monitoring)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2020to 21 Mar 2022
- 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 19 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women diagnosed with GDM
Who cannot join
- pre-gestational diabetes type 1 or type 2 diabetes mellitus, diagnosed as pregnancy induced hypertension before GDM
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lifestyle Modification on Pregnancy Outcomes for Pregnant Women With Gestational Diabetes: an Evidence Based.
Effect of lifestyle modification on pregnancy outcome for pregnant women with GDM
Read the detailed description
evaluate the effect of lifestyle modification on pregnancy outcome among GDM women.
Primary outcomes: excessive gestational weight gain, uncontrolled blood glucose level, PIH, polyhydromnios, oligohydrominos, recurrent monilia infection and urinary tract infection , intra uterine fetal death (IUFD), intra uterine growth restriction (IUGR), premature preterm rupture of membrane and Diabetic ketoacidosis.
Secondary outcomes: preterm labor, caesarian section, neonatal hypoglycemia, stillbirth, respiratory distress syndrome, small for gestational age (SGA), large for gestational age (LGA) ,neonatal intensive care unit (NICU) and failure to initiate or maintain breast feeding.
- Conditions
- GDM, Lifestyle, Pregnancy Outcome
- Being tested
- lifestyle modification (dietary modification), lifestyle modification (physical activity), lifestyle modification( self glucose monitoring)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle modification (dietary modification)Behavioural
Also called low glycemic index diet
low glycemic index diet the researcher gave detail information about (importance of LGI diet, component of food, number of meals and snake, example of food taken in breakfast, lunch, dinner and snake in between, food allowed and not allowed). After that, the researcher required from the woman to make an example of food for one day according to her income level, if correction of the content of food needed, the researcher will explain this point again.
lifestyle modification (physical activity)Behavioural
Also called brisk waking exercise or seated arm exercise or both type performed
health teaching about choose between two types of exercise to be selected according to the ability of GDM women to perform : brisk walking or seated arm exercise or selected both. Brisk walking should be performed for at least half an hour three time /week, while, seated arm exercise done three time after each meal for10 minute in each time. The researcher given a detail information about both types and its importance in decreasing blood glucose level, also how to perform and what should be done in case of appearance of fatigue manifestation during exercise, and the women have choice for perform both or selected one to perform according to your health condition.
lifestyle modification( self glucose monitoring)Behavioural
Also called self glucose monitoring
self-glucose monitoring the researcher explain the important of monitoring blood glucose level and instruct the women about how to perform self- glucose measuring, recording way of the result in schedule and to bring this result in the next antenatal visit. The women who have digital blood glucose monitoring instructed to measure it at least 5 time/day. while, the women who didn't have digital blood glucose monitoring measure went to nearest pharmacy to measure blood glucose at least one time per day especially when the woman felt the signs and symptoms of hypo or hyperglycemia and recorded the result in paper or sent the result in whatsapp for the researcher if you have whatsapp application. In addition to give the woman instruction about sings symptoms of hypoglycemia and hyperglycemia and the proper ways for management
| Study group | Role | What they receive |
|---|---|---|
| lifesyle modification | Experimental | intervention group will take lifestyle modification protocol which composed of health teaching about low glycemic index diet, physical activity and self glucose monitoring Receives: Behavioral: lifestyle modification (dietary modification); Behavioral: lifestyle modification (physical activity); Behavioral: lifestyle modification( self glucose monitoring) |
| control group | No intervention | routine care of the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of lifestyle modification among GDM on pregnancy outcome
change blood glucose level (fasting blood sugar (FBS) and random blood sugar (RBS) measured with digital blood glucose monitoring by using test strips; HA1C and urine analysis done in the laboratory and get the result)
Measured: from 28 weeks of gestational until the first 24hours postpartum
effect of lifestyle modification among GDM on pregnancy outcome
attained proper weight gain during pregnancy. Weight was measured utilizing bath scale where the accuracy were obtained through balancing zero prior weighting
Measured: from 28 weeks of gestational until the first 24hours postpartum
effect of lifestyle modification among GDM on pregnancy outcome
occurrence of maternal complications during pregnancy((preeclampsia, urinary infection, monilia infection, premature rupture of membrane, bleeding during pregnancy, and diabetic ketoacidosis).this will recorded by using tool to assess this compilication
Measured: from 28 weeks of gestational until the first 24hours postpartum
effect of lifestyle modification among GDM on pregnancy outcome
occurrences of fetal complications during pregnancy detected by the result of ultrasound done by physician (decrease fetal movement count, IUGR, and IUFD)
Measured: from 28 weeks of gestational until the first 24hours postpartum
effect of lifestyle modification among GDM on pregnancy outcome
Intrapartum assessment of the outcomes. The researcher assessed mode of delivery and complications occurrence to the GDM women and their neonatal during intrapartum from the hospital filling . The maternal complications (preterm labor, prolonged labor, traumatic labor, intrapartum instrumental delivery, perineal trauma or tear, postoperative hemorrhage and infection). While regarding to fetal assessment (occurrences of intra uterine fetal death, preterm birth, Birth trauma (shoulder dystocia, bone fracture, cerebral palsy), fetal distress, macrosomia, IUGR, five-minute Apgar less than seven, stillbirth)
Measured: from 28 weeks of gestational until the first 24hours postpartum
effect of lifestyle modification among GDM on pregnancy outcome
Postpartum assessment of the outcomes.The researcher assessed each woman and their newborn for the first 24 hours postpartum in both groups. It included the following items:1) assessed maternal vital sings: Temperature was assessed by using thermometer; blood pressure was measured through a sphygmomanometer; 2) maternal and newborn lab investigation as FBS and postprandial using digital blood glucose monitoring with test strips.
In addition to, assess the occurrences of Maternal and newborn complications as; postpartum hemorrhage, failure or delay for initiating breastfeeding, neonatal hypoglycemia, respiratory distress syndrome, sings of jaundice, (SGA or LGA), neonatal death, and neonatal administration to ICU, and preterm birth.
Measured: from 28 weeks of gestational until the first 24hours postpartum
effect of lifestyle modification among GDM on pregnancy outcome
newborn gestational age. assessment of the neonatal anthropometric measurements such as weight which taken from labor sheet, length was measured from head to toe when the neonates were in supine position and legs were extended using measurement tap. Then, measured head circumference through measurement tape firmly around head above the eyebrow ridge. The researcher plotted neonatal weight, length and head circumference by gestational age on the growth chart, to determine if the growth below 10th percentile the neonate was small for gestational age (SGA), if the growth above the 90th percentile, the neonates was large for gestational age (LGA) called macrocosmic baby, if the growth was in between 10th and 90th percentiles, the neonates was appropriate for gestational age (AGA). Postpartum assessment taken 30 minutes for each woman in each group.
Measured: from 28 weeks of gestational until the first 24hours postpartum
effect of lifestyle modification among GDM on pregnancy outcome
body mass index(was calculated through the formula "weight in Kg, divided by height squared in meters"; class of weight using the international classification of adult underweight<18.5, normal weight 18.5-24.9, over weight 25-29.9 and obesity ≥ 30 according to BMI )
Measured: from 28 weeks of gestational until the first 24hours postpartum
effect of lifestyle modification among GDM on pregnancy outcome
height measured by using measurement tape. firstStand with your feet flat on the floor with your heels against the corner where the wall and floor meet. Make sure your head, shoulders, and buttocks are touching the wall. then use Use a tape measure - - to measure the distance from the floor to the mark on the wall.
Stand up straight with your eyes looking straight ahead. Your line of sight and chin should be parallel to the floor.
Measured: from 28 weeks of gestational until the first 24hours postpartum
effect of lifestyle modification among GDM on pregnancy outcome
assessment of fasting blood sugar and random blood sugar for the postpartum GDM women and their neonatal in the first 24 hours postpartum by using (fasting blood sugar (FBS) and random blood sugar (RBS) measured with digital blood glucose monitoring by using test strips
Measured: from 28 weeks of gestational until the first 24hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start11 Nov 2020
- Primary completion28 Aug 2021
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control and study group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Said Mahmoud Elgamasy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355038
- Sponsor's protocol ID
- Basma said Mahmoud El gamasy
- Acronym
- Lifestyle
- Status last verified
- Mar 2022
- First submitted
- 2 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lifestyle Modification on Pregnancy Outcomes for Pregnant Women With Gestational Diabetes: an Evidence Based.
- ClinicalTrials.gov ID
- NCT05355038
- Acronym / sponsor ID
- Lifestyle / Basma said Mahmoud El gamasy
- Conditions
- GDM, Lifestyle, Pregnancy Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 28 Aug 2021 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 2 May 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.
Effect of lifestyle modification on pregnancy outcome for pregnant women with GDM
Detailed description
evaluate the effect of lifestyle modification on pregnancy outcome among GDM women.
Primary outcomes: excessive gestational weight gain, uncontrolled blood glucose level, PIH, polyhydromnios, oligohydrominos, recurrent monilia infection and urinary tract infection , intra uterine fetal death (IUFD), intra uterine growth restriction (IUGR), premature preterm rupture of membrane and Diabetic ketoacidosis.
Secondary outcomes: preterm labor, caesarian section, neonatal hypoglycemia, stillbirth, respiratory distress syndrome, small for gestational age (SGA), large for gestational age (LGA) ,neonatal intensive care unit (NICU) and failure to initiate or maintain breast feeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- control and study group
| Arm | Type | Receives |
|---|---|---|
| lifesyle modification | Experimental | Behavioral: lifestyle modification (dietary modification), Behavioral: lifestyle modification (physical activity), Behavioral: lifestyle modification( self glucose monitoring)intervention group will take lifestyle modification protocol which composed of health teaching about low glycemic index diet, physical activity and self glucose monitoring |
| control group | No intervention | –routine care of the hospital |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women diagnosed with GDM
Key exclusion criteria (1 listed)
- pre-gestational diabetes type 1 or type 2 diabetes mellitus, diagnosed as pregnancy induced hypertension before GDM
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 |
|---|---|---|
| lifestyle modification (dietary modification)Also: low glycemic index dietlow glycemic index diet the researcher gave detail information about (importance of LGI diet, component of food, number of meals and snake, example of food taken in breakfast, lunch, dinner and snake in between, food allowed and not allowed). After that, the researcher required from the woman to make an example of food for one day according to her income level, if correction of the content of food needed, the researcher will explain this point again. | Behavioural | lifesyle modification |
| lifestyle modification (physical activity)Also: brisk waking exercise or seated arm exercise or both type performedhealth teaching about choose between two types of exercise to be selected according to the ability of GDM women to perform : brisk walking or seated arm exercise or selected both. Brisk walking should be performed for at least half an hour three time /week, while, seated arm exercise done three time after each meal for10 minute in each time. The researcher given a detail information about both types and its importance in decreasing blood glucose level, also how to perform and what should be done in case of appearance of fatigue manifestation during exercise, and the women have choice for perform both or selected one to perform according to your health condition. | Behavioural | lifesyle modification |
| lifestyle modification( self glucose monitoring)Also: self glucose monitoringself-glucose monitoring the researcher explain the important of monitoring blood glucose level and instruct the women about how to perform self- glucose measuring, recording way of the result in schedule and to bring this result in the next antenatal visit. The women who have digital blood glucose monitoring instructed to measure it at least 5 time/day. while, the women who didn't have digital blood glucose monitoring measure went to nearest pharmacy to measure blood glucose at least one time per day especially when the woman felt the signs and symptoms of hypo or hyperglycemia and recorded the result in paper or sent the result in whatsapp for the researcher if you have whatsapp application. In addition to give the woman instruction about sings symptoms of hypoglycemia and hyperglycemia and the proper ways for management | Behavioural | lifesyle modification |
Primary outcome
effect of lifestyle modification among GDM on pregnancy outcome
Time frame: from 28 weeks of gestational until the first 24hours postpartum
change blood glucose level (fasting blood sugar (FBS) and random blood sugar (RBS) measured with digital blood glucose monitoring by using test strips; HA1C and urine analysis done in the laboratory and get the result)
effect of lifestyle modification among GDM on pregnancy outcome
Time frame: from 28 weeks of gestational until the first 24hours postpartum
attained proper weight gain during pregnancy. Weight was measured utilizing bath scale where the accuracy were obtained through balancing zero prior weighting
effect of lifestyle modification among GDM on pregnancy outcome
Time frame: from 28 weeks of gestational until the first 24hours postpartum
occurrence of maternal complications during pregnancy((preeclampsia, urinary infection, monilia infection, premature rupture of membrane, bleeding during pregnancy, and diabetic ketoacidosis).this will recorded by using tool to assess this compilication
effect of lifestyle modification among GDM on pregnancy outcome
Time frame: from 28 weeks of gestational until the first 24hours postpartum
occurrences of fetal complications during pregnancy detected by the result of ultrasound done by physician (decrease fetal movement count, IUGR, and IUFD)
effect of lifestyle modification among GDM on pregnancy outcome
Time frame: from 28 weeks of gestational until the first 24hours postpartum
Intrapartum assessment of the outcomes. The researcher assessed mode of delivery and complications occurrence to the GDM women and their neonatal during intrapartum from the hospital filling . The maternal complications (preterm labor, prolonged labor, traumatic labor, intrapartum instrumental delivery, perineal trauma or tear, postoperative hemorrhage and infection). While regarding to fetal assessment (occurrences of intra uterine fetal death, preterm birth, Birth trauma (shoulder dystocia, bone fracture, cerebral palsy), fetal distress, macrosomia, IUGR, five-minute Apgar less than seven, stillbirth)
effect of lifestyle modification among GDM on pregnancy outcome
Time frame: from 28 weeks of gestational until the first 24hours postpartum
Postpartum assessment of the outcomes.The researcher assessed each woman and their newborn for the first 24 hours postpartum in both groups. It included the following items:1) assessed maternal vital sings: Temperature was assessed by using thermometer; blood pressure was measured through a sphygmomanometer; 2) maternal and newborn lab investigation as FBS and postprandial using digital blood glucose monitoring with test strips. In addition to, assess the occurrences of Maternal and newborn complications as; postpartum hemorrhage, failure or delay for initiating breastfeeding, neonatal hypoglycemia, respiratory distress syndrome, sings of jaundice, (SGA or LGA), neonatal death, and neonatal administration to ICU, and preterm birth.
effect of lifestyle modification among GDM on pregnancy outcome
Time frame: from 28 weeks of gestational until the first 24hours postpartum
newborn gestational age. assessment of the neonatal anthropometric measurements such as weight which taken from labor sheet, length was measured from head to toe when the neonates were in supine position and legs were extended using measurement tap. Then, measured head circumference through measurement tape firmly around head above the eyebrow ridge. The researcher plotted neonatal weight, length and head circumference by gestational age on the growth chart, to determine if the growth below 10th percentile the neonate was small for gestational age (SGA), if the growth above the 90th percentile, the neonates was large for gestational age (LGA) called macrocosmic baby, if the growth was in between 10th and 90th percentiles, the neonates was appropriate for gestational age (AGA). Postpartum assessment taken 30 minutes for each woman in each group.
effect of lifestyle modification among GDM on pregnancy outcome
Time frame: from 28 weeks of gestational until the first 24hours postpartum
body mass index(was calculated through the formula "weight in Kg, divided by height squared in meters"; class of weight using the international classification of adult underweight<18.5, normal weight 18.5-24.9, over weight 25-29.9 and obesity ≥ 30 according to BMI )
effect of lifestyle modification among GDM on pregnancy outcome
Time frame: from 28 weeks of gestational until the first 24hours postpartum
height measured by using measurement tape. firstStand with your feet flat on the floor with your heels against the corner where the wall and floor meet. Make sure your head, shoulders, and buttocks are touching the wall. then use Use a tape measure - - to measure the distance from the floor to the mark on the wall. Stand up straight with your eyes looking straight ahead. Your line of sight and chin should be parallel to the floor.
effect of lifestyle modification among GDM on pregnancy outcome
Time frame: from 28 weeks of gestational until the first 24hours postpartum
assessment of fasting blood sugar and random blood sugar for the postpartum GDM women and their neonatal in the first 24 hours postpartum by using (fasting blood sugar (FBS) and random blood sugar (RBS) measured with digital blood glucose monitoring by using test strips
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 2 May 2022.
Related trials for GDM
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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 lifestyle modification (dietary modification), lifestyle modification (physical activity) and lifestyle modification( self glucose monitoring) in people with GDM and Lifestyle, run by Cairo University at 1 site in Egypt.
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 2 May 2022. 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 Egypt. 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?
effect of lifestyle modification among GDM on pregnancy outcome (time frame: from 28 weeks of gestational until the first 24hours postpartum). The study lists 10 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 2 May 2022.