Overweight and Obesity During PregnancyNCT07279337
Effectiveness of Nutrition Counseling on Gestational Weight Gain Among Overweight and Obese Pregnant Women in Lebanon
A study testing Intervention group that received detailed nutrition assessment, counseling, and monitoring in people with Overweight and Obesity During Pregnancy, run by University of Nicosia at 1 site in Lebanon.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Overweight and Obesity During Pregnancy
- What is being tested?
- Intervention group that received detailed nutrition assessment, counseling, and monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Feb 2021to 20 Jun 2023
- 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 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- In their first trimester of pregnancy
- With a pre-pregnancy Body Mass Index (BMI) ranging from 25 to 35 kg/m², classifying them as overweight or obese.
- Women were required to be attending regular prenatal care visits at randomly selected gynecology clinics
- The ability and willingness to meet with a licensed dietitian for individualized counseling.
- Commitment to follow the recommended nutrition and physical activity guidelines throughout the duration of the study
Who cannot join
- Contraindications to exercise
- Medical conditions such as uncontrolled hypertension, insulin-dependent diabetes, uncontrolled thyroid disease, multiple gestation, persistent bleeding in the first trimester
- History of recurrent miscarriages.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Overweight and Obesity During Pregnancy
- Being tested
- Intervention group that received detailed nutrition assessment, counseling, and monitoring
- Keywords
- Nutrition, pregnancy, obesity, dietary intervention, gestational weight gain
- Medical subject headings
- Overweight, Obesity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group that received detailed nutrition assessment, counseling, and monitoringBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| nutrition counseling provided by licensed dietitians | Experimental | 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. Receives: Behavioral: Intervention group that received detailed nutrition assessment, counseling, and monitoring |
| Control group | No intervention | Usual prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Total weight gained during pregnancy
Measured: 6-8 months period
Secondary outcomes (1)
adherence to IOM weight gain guidelines
comparing actual gestational weight gain to guidelines based on pre-BMI category
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Feb 2021
- Primary completion20 Mar 2022
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and Obesity During PregnancyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nicosia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessy Rizk, University of Nicosia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279337
- Sponsor's protocol ID
- LIUIRB-200706-JR1
- Status last verified
- Feb 2021
- First submitted
- 30 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It depends on what information is needed. Values like gestational weight gain of participants can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nutrition Counseling on Gestational Weight Gain Among Overweight and Obese Pregnant Women in Lebanon
- ClinicalTrials.gov ID
- NCT07279337
- Acronym / sponsor ID
- LIUIRB-200706-JR1
- Conditions
- Overweight and Obesity During Pregnancy
- Keywords
- Nutrition, pregnancy, obesity, dietary intervention, gestational weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of NicosiaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 12 Dec 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutrition counseling provided by licensed dietitians | Experimental | Behavioral: Intervention group that received detailed nutrition assessment, counseling, and monitoringThe 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. |
| Control group | No intervention | –Usual prenatal care |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In their first trimester of pregnancy
- With a pre-pregnancy Body Mass Index (BMI) ranging from 25 to 35 kg/m², classifying them as overweight or obese.
- Women were required to be attending regular prenatal care visits at randomly selected gynecology clinics
Key exclusion criteria (3 listed)
- Contraindications to exercise
- Medical conditions such as uncontrolled hypertension, insulin-dependent diabetes, uncontrolled thyroid disease, multiple gestation, persistent bleeding in the first trimester
- History of recurrent miscarriages.
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 |
|---|---|---|
| Intervention group that received detailed nutrition assessment, counseling, and monitoringThe 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 | Behavioural | nutrition counseling provided by licensed dietitians |
Primary outcome
Gestational weight gain
Time frame: 6-8 months period
Total weight gained during pregnancy
1 secondary outcome
adherence to IOM weight gain guidelines
Time frame: 1 month
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 12 Dec 2025.
- Individual participant dataSharing planned: Undecided. It depends on what information is needed. Values like gestational weight gain of participants can be shared.
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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 Intervention group that received detailed nutrition assessment, counseling, and monitoring in people with Overweight and Obesity During Pregnancy, run by University of Nicosia at 1 site in Lebanon.
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 5 inclusion and 3 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 12 Dec 2025. 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 Lebanon. 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?
Gestational weight gain (time frame: 6-8 months period). 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 12 Dec 2025.