An interventional study of Intervention group that received detailed nutrition assessment, counseling, and monitoring in Overweight and Obesity During Pregnancy, sponsored by University of Nicosia. Completed at 1 site in Lebanon. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by University of Nicosia · Not applicable, Interventional, and Prevention
A high percentage of women are either overweight or obese before pregnancy and many women are exceeding the gestational weight gain recommendations when pregnant. Excessive gestational weight gain increases the risk of maternal and fetal complications. To help with this, women need to be advised about the appropriate weight gain recommendation according to their pre-pregnancy body weight. One way to do this is by receiving dietary and lifestyle advices during prenatal visits. This study will contribute to knowledge that will inform dietary guidelines and public policy on how to manage gestational weight gain and thus improve maternal and fetal outcomes.
If you choose to participate in the suggested study, you will be seen by a dietitian during the first trimester for an in-depth counseling session and provide you with individualized nutrition counseling regarding your physical activity, dietary, and weight gain goals. You will then be asked to self-monitor your diet, weight, and physical activity. Study staff will instruct you on how to keep weekly paper logs of weight, activity, and diet that you will share with your dietitian weekly or biweekly by telephone. In order to determine the total gestational weight gain and to determine the impact of nutrition intervention on the health of your baby, data collectors will review your medical record to obtain your weight at delivery, your infants' birthweight, and method of delivery.
Apart from the 30 minutes of your time taken during the nutrition counseling session and your dietary and activity commitment according to the recommendations, we can expect no risks or inconveniences for you. Your participation in the study is voluntary and you may withdraw your participation from the study at any time. Your personal health information will be treated as confidential and all persons involved in the study are committed to respecting your privacy.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Nicosia is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women were required to be attending regular prenatal care visits at randomly selected gynecology clinics
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group participated in an initial 30-60-minute nutrition counseling session with a registered dietitian during the first trimester. Counseling emphasized balanced nutrition, limiting added sugars and unhealthy fats, and promoting whole foods. Individualized weight gain targets were set based on Institute of Medicine (IOM) guidelines of 2009: 6.8-11.4 kg for overweight women and 5-9 kg for women with obesity. Participants were also advised to engage in 150 minutes of moderate-intensity physical activity per week, as recommended by health guidelines. Follow-ups were conducted every 10-15 days via smartphone applications (e.g., WhatsApp, Zoom) with an average of 14 nutrition follow-ups throughout the intervention. The follow-ups were utilizing asynchronous telehealth platform that was secure and user-friendly.
Behavioral: Intervention group that received detailed nutrition assessment, counseling, and monitoring
Usual prenatal care
The intervention group participated in an initial 30-60-minute nutrition counseling session with a registered dietitian during the first trimester. Counseling emphasized balanced nutrition, limiting added sugars and unhealthy fats, and promoting whole foods. Individualized weight gain targets were set based on Institute of Medicine (IOM) guidelines of 2009: 6.8-11.4 kg for overweight women and 5-9 kg for women with obesity. Participants were also advised to engage in 150 minutes of moderate-intensity physical activity per week, as recommended by health guidelines. Follow-ups were conducted every 10-15 days via smartphone applications (e.g., WhatsApp, Zoom) with an average of 14 nutrition follow-ups throughout the intervention. The follow-ups were utilizing asynchronous telehealth platform that was secure
Gestational weight gain
Total weight gained during pregnancy
Time frame: 6-8 months period
adherence to IOM weight gain guidelines
comparing actual gestational weight gain to guidelines based on pre-BMI category
Time frame: 1 month
Plan to share: Undecided — It depends on what information is needed. Values like gestational weight gain of participants can be shared.
No publications or documents are linked to this record.
Ran from Feb 2021 to primary completion in Mar 2022, 13 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 13 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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University of Nicosia