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Effect of Lifestyle Modification on Pregnancy Outcome for GDM

Effect of Lifestyle Modification on Pregnancy Outcomes for Pregnant Women With Gestational Diabetes: an Evidence Based.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05355038
Acronym
Lifestyle
Enrollment
150
Registered
2022-05-02
Start date
2020-11-11
Completion date
2022-03-21
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GDM, Lifestyle, Pregnancy Outcome

Brief summary

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.

Interventions

BEHAVIORALlifestyle modification (dietary modification)

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.

BEHAVIORALlifestyle modification (physical activity)

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.

BEHAVIORALlifestyle modification( 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

control group were in the first 3 day of week (saturday ,sunday ,monday) study group were in the 2nd three day of week(tuesday, wednsday,thursday)

Intervention model description

control and study group

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* women diagnosed with GDM

Exclusion criteria

* pre-gestational diabetes type 1 or type 2 diabetes mellitus, diagnosed as pregnancy induced hypertension before GDM

Design outcomes

Primary

MeasureTime frameDescription
effect of lifestyle modification among GDM on pregnancy outcomefrom 28 weeks of gestational until the first 24hours postpartumchange 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026