OverweightNCT07845773
Effects of Antenatal Nutrition Counseling on Maternal and Infant Outcomes
A study testing Dietitian-Led Nutrition Education and Counseling in people with Overweight and Pregnancy, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
This randomized controlled trial evaluated whether individualized antenatal nutrition counseling provided between 24 and 36 weeks of gestation could improve maternal dietary quality, dietary inflammatory potential, gestational weight gain, postpartum depressive symptoms, and infant growth outcomes among pregnant women… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Pregnancy
- What is being tested?
- Dietitian-Led Nutrition Education and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Jun 2022to 30 Dec 2025
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women at 24 weeks of gestation
- Aged 19-40 years
- Singleton pregnancy
- Pre-pregnancy body mass index between 25 and 30 kg/m²
- Willingness to participate and provide informed consent
Who cannot join
- Multiple pregnancy
- Gestational diabetes mellitus diagnosed before or at enrollment
- Chronic disease requiring medical treatment
- Pregnancy complications occurring before recruitment
- Current smoking
- Receiving nutrition counseling from another dietitian or healthcare professional
Show all 9Show fewer
- History of preterm birth
- History of intrauterine growth restriction or delivery of a low-birth-weight infant (<2500 g)
- History of fetal anomaly or stillbirth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Individualized Antenatal Nutrition Counseling on Maternal Diet Quality, Gestational Weight Gain, Postpartum Depression, and Infant Growth: A Randomized Controlled Trial
This randomized controlled trial evaluated whether individualized antenatal nutrition counseling provided between 24 and 36 weeks of gestation could improve maternal dietary quality, dietary inflammatory potential, gestational weight gain, postpartum depressive symptoms, and infant growth outcomes among pregnant women with a pre-pregnancy body mass index of 25-30 kg/m². Participants were assigned to either an intervention group receiving six structured nutrition counseling sessions or a control group receiving standard written nutrition information and routine antenatal care. Assessments were conducted at 24 weeks and 36 weeks of gestation and at two months postpartum.
Read the detailed description
Pregnant women with a singleton pregnancy and a pre-pregnancy body mass index of 25-30 kg/m² were recruited at 24 weeks of gestation from private antenatal clinics in Northern Cyprus. Participants were randomly assigned to an intervention or control group.
The intervention consisted of six dietitian-led nutrition counseling sessions delivered between 24 and 36 weeks of gestation. The first and final sessions were conducted face-to-face, while the interim sessions were delivered online. Counseling covered healthy eating during pregnancy, recommended gestational weight gain, Mediterranean dietary principles, anti-inflammatory and pro-inflammatory foods, dietary diversity, meal planning, portion control, and individualized dietary recommendations. The control group received a standard nutrition booklet and routine antenatal care.
Maternal dietary inflammatory potential, Mediterranean diet adherence, dietary diversity, diet quality, anthropometric measurements, and gestational weight gain were assessed. Postpartum depressive symptoms and infant anthropometric outcomes were evaluated at two months postpartum.
- Conditions
- Overweight, Pregnancy
- Being tested
- Dietitian-Led Nutrition Education and Counseling
- Keywords
- Antenatal Nutrition Counseling, Maternal Nutrition, Dietary Inflammatory Index, Mediterranean Diet, Dietary Diversity, Gestational Weight Gain, Postpartum Depression, Infant Growth
- Medical subject headings
- Overweight, Gestational Weight Gain, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietitian-Led Nutrition Education and CounselingBehavioural
Participants received six dietitian-led nutrition education and counseling sessions between 24 and 36 weeks of gestation. Sessions were delivered face-to-face at 24 and 36 weeks and online at 28, 30, 32, and 34 weeks. Content included healthy eating during pregnancy, recommended gestational weight gain, Mediterranean dietary principles, anti-inflammatory and pro-inflammatory foods, dietary diversity, meal planning, portion control, and individualized dietary recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Dietitian-Led Nutrition Education and Counseling Group | Experimental | Participants received six dietitian-led nutrition education and counseling sessions between 24 and 36 weeks of gestation. The sessions covered healthy eating during pregnancy, recommended gestational weight gain, Mediterranean dietary principles, anti-inflammatory and pro-inflammatory foods, dietary diversity, meal planning, portion control, and individualized dietary recommendations. Receives: Behavioral: Dietitian-Led Nutrition Education and Counseling |
| Standard Antenatal Care | No intervention | Participants received a standard pregnancy nutrition booklet and routine antenatal care without individualized nutrition education and counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dietary Inflammatory Index Score
Dietary Inflammatory Index scores were calculated from participants' dietary intake data. Higher scores indicate a more pro-inflammatory diet, whereas lower scores indicate a more anti-inflammatory diet.
Measured: At 24 and 36 weeks of gestation and at 2 months postpartum
Change in Mediterranean Diet Adherence Screener Score
Mediterranean Diet Adherence Screener scores range from 0 to 14. Higher scores indicate greater adherence to the Mediterranean diet.
Measured: At 24 and 36 weeks of gestation and at 2 months postpartum
Change in Minimum Dietary Diversity for Women Score
Minimum Dietary Diversity for Women scores reflect the number of food groups consumed from 10 defined food groups. Higher scores indicate greater dietary diversity.
Measured: At 24 and 36 weeks of gestation and at 2 months postpartum
Change in Adapted Healthy Eating Index for Pregnant Women Score
The Adapted Healthy Eating Index for Pregnant Women assesses overall diet quality during pregnancy. Higher scores indicate better diet quality.
Measured: At 24 and 36 weeks of gestation
Secondary outcomes (6)
Gestational Weight Gain
Maternal gestational weight gain was calculated in kilograms from measured body weight during pregnancy. Higher values indicate greater weight gain.
Measured: From 24 to 36 weeks of gestation
Change in Maternal Mid-Upper Arm Circumference
Maternal mid-upper arm circumference was measured in centimeters using a non-stretchable measuring tape.
Measured: At 24 and 36 weeks of gestation
Edinburgh Postnatal Depression Scale Score
Postpartum depressive symptoms were assessed using the 10-item Edinburgh Postnatal Depression Scale. Total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.
Measured: At 2 months postpartum
Infant Body Weight
Infant body weight was measured in grams.
Measured: At birth and at 2 months of age
Infant Length
Infant recumbent length was measured in centimeters.
Measured: At birth and at 2 months of age
Infant Head Circumference
Infant head circumference was measured in centimeters.
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start15 Jun 2022
- Primary completion10 Jun 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845773
- Sponsor's protocol ID
- EMU-NUTR-PREG-2022-01
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in the published article will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized Antenatal Nutrition Counseling on Maternal Diet Quality, Gestational Weight Gain, Postpartum Depression, and Infant Growth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07845773
- Acronym / sponsor ID
- EMU-NUTR-PREG-2022-01
- Conditions
- Overweight, Pregnancy
- Keywords
- Antenatal Nutrition Counseling, Maternal Nutrition, Dietary Inflammatory Index, Mediterranean Diet, Dietary Diversity, Gestational Weight Gain, Postpartum Depression, Infant Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 29 Sep 2026 (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.
This randomized controlled trial evaluated whether individualized antenatal nutrition counseling provided between 24 and 36 weeks of gestation could improve maternal dietary quality, dietary inflammatory potential, gestational weight gain, postpartum depressive symptoms, and infant growth outcomes among pregnant women with a pre-pregnancy body mass index of 25-30 kg/m². Participants were assigned to either an intervention group receiving six structured nutrition counseling sessions or a control group receiving standard written nutrition information and routine antenatal care. Assessments were conducted at 24 weeks and 36 weeks of gestation and at two months postpartum.
Detailed description
Pregnant women with a singleton pregnancy and a pre-pregnancy body mass index of 25-30 kg/m² were recruited at 24 weeks of gestation from private antenatal clinics in Northern Cyprus. Participants were randomly assigned to an intervention or control group.
The intervention consisted of six dietitian-led nutrition counseling sessions delivered between 24 and 36 weeks of gestation. The first and final sessions were conducted face-to-face, while the interim sessions were delivered online. Counseling covered healthy eating during pregnancy, recommended gestational weight gain, Mediterranean dietary principles, anti-inflammatory and pro-inflammatory foods, dietary diversity, meal planning, portion control, and individualized dietary recommendations. The control group received a standard nutrition booklet and routine antenatal care.
Maternal dietary inflammatory potential, Mediterranean diet adherence, dietary diversity, diet quality, anthropometric measurements, and gestational weight gain were assessed. Postpartum depressive symptoms and infant anthropometric outcomes were evaluated at two months postpartum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietitian-Led Nutrition Education and Counseling Group | Experimental | Behavioral: Dietitian-Led Nutrition Education and CounselingParticipants received six dietitian-led nutrition education and counseling sessions between 24 and 36 weeks of gestation. The sessions covered healthy eating during pregnancy, recommended gestational weight gain, Mediterranean dietary principles, anti-inflammatory and pro-inflammatory foods, dietary diversity, meal planning, portion control, and individualized dietary recommendations. |
| Standard Antenatal Care | No intervention | –Participants received a standard pregnancy nutrition booklet and routine antenatal care without individualized nutrition education and counseling. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women at 24 weeks of gestation
- Aged 19-40 years
- Singleton pregnancy
- Pre-pregnancy body mass index between 25 and 30 kg/m²
- Willingness to participate and provide informed consent
Key exclusion criteria (9 listed)
- Multiple pregnancy
- Gestational diabetes mellitus diagnosed before or at enrollment
- Chronic disease requiring medical treatment
- Pregnancy complications occurring before recruitment
- Current smoking
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 |
|---|---|---|
| Dietitian-Led Nutrition Education and CounselingParticipants received six dietitian-led nutrition education and counseling sessions between 24 and 36 weeks of gestation. Sessions were delivered face-to-face at 24 and 36 weeks and online at 28, 30, 32, and 34 weeks. Content included healthy eating during pregnancy, recommended gestational weight gain, Mediterranean dietary principles, anti-inflammatory and pro-inflammatory foods, dietary diversity, meal planning, portion control, and individualized dietary recommendations. | Behavioural | Dietitian-Led Nutrition Education and Counseling Group |
Primary outcome
Change in Dietary Inflammatory Index Score
Time frame: At 24 and 36 weeks of gestation and at 2 months postpartum
Dietary Inflammatory Index scores were calculated from participants' dietary intake data. Higher scores indicate a more pro-inflammatory diet, whereas lower scores indicate a more anti-inflammatory diet.
Change in Mediterranean Diet Adherence Screener Score
Time frame: At 24 and 36 weeks of gestation and at 2 months postpartum
Mediterranean Diet Adherence Screener scores range from 0 to 14. Higher scores indicate greater adherence to the Mediterranean diet.
Change in Minimum Dietary Diversity for Women Score
Time frame: At 24 and 36 weeks of gestation and at 2 months postpartum
Minimum Dietary Diversity for Women scores reflect the number of food groups consumed from 10 defined food groups. Higher scores indicate greater dietary diversity.
Change in Adapted Healthy Eating Index for Pregnant Women Score
Time frame: At 24 and 36 weeks of gestation
The Adapted Healthy Eating Index for Pregnant Women assesses overall diet quality during pregnancy. Higher scores indicate better diet quality.
6 secondary outcomes
Gestational Weight Gain
Time frame: From 24 to 36 weeks of gestation
Change in Maternal Mid-Upper Arm Circumference
Time frame: At 24 and 36 weeks of gestation
Edinburgh Postnatal Depression Scale Score
Time frame: At 2 months postpartum
Infant Body Weight
Time frame: At birth and at 2 months of age
Infant Length
Time frame: At birth and at 2 months of age
Infant Head Circumference
Time frame: At birth
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 29 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in the published article will be made available upon reasonable request.
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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 Dietitian-Led Nutrition Education and Counseling in people with Overweight and Pregnancy, run by Eastern Mediterranean University at 1 site in Cyprus.
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 9 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 29 Sep 2026. 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 Cyprus. 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?
Change in Dietary Inflammatory Index Score (time frame: At 24 and 36 weeks of gestation and at 2 months postpartum). The study lists 4 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 29 Sep 2026.