The "first 1000 days of life", from conception to 2 years of life, are crucial for promoting the health of both mother and baby. During this period, a woman's diet and lifestyle play a significant role in determining the future health of the child. The perinatal period is an ideal time for regular contact with healthcare providers who can institute an intervention to encourage pregnant women to make nutritional changes to improve their health and that of their babies.

Therefore, an educational program on an appropriate lifestyle during the "first 1000 days" can represent a crucial primary prevention strategy in reducing the risk of developing obesity and non-communicable diseases (NCDs) during childhood and later adulthood.

Conditions: Pregnancy, Lactation
Being tested: Lifestyle Educational Intervention
Keywords: Lifestyle, Health, First one-thousand days, Dietary habits
Medical subject headings: Breast Feeding, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lifestyle Educational InterventionOther
Also called LEI
The Lifestyle Educational Intervention (LEI) consists of promoting a healthy lifestyle during pregnancy and breastfeeding. In particular, the contents concern: i). macro- and micronutrient requirements during pregnancy/breastfeeding; ii). definition of the concept of the food pyramid and healthy plate also considering aspects of food sustainability; iii). definition of the principles of food safety during pregnancy; iv). importance of maternal and infant sleep quality; v). importance of maternal physical activity during pregnancy and lactation; vi). psychological aspects regarding the mother-child dyad.

Study groups in NCT06264349
Study group	Role	What they receive
Group A: frontal lessons	Experimental	50 women will receive a Lifestyle Educational Intervention (LEI) from research staff regarding a correct lifestyle during pregnancy and lactation through 6 interactive online lectures lasting approximately 30 minutes each. Receives: Other: Lifestyle Educational Intervention
Group B: web-mobile app	Experimental	50 women will receive Lifestyle Educational Intervention (LEI) from research staff regarding a correct lifestyle during pregnancy and lactation through a digital tool (web-mobile app), previously developed. Receives: Other: Lifestyle Educational Intervention
Control Group	No intervention	50 women of the same age as the intervention group will be selected within the LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children (LIMIT) project cohort. The LIMIT protocol is registered on clinicaltrials.gov (NCT04960670)

What is being measured

The primary outcome is the main question the study is designed to answer.

Gestational weight gain management
Evaluation of the LEI program effectiveness on gestational weight gain (GWG) management. GWG (Kg) will be calculated retrospectively as the difference between the weight at the first and last prenatal visit, just before delivery. Based on that, women will be classified into 3 categories, according to the IOM (U.S.) and the National Research Council (U.S.) Committee to Reexamine IOM Pregnancy Weight Guidelines, as follow:
i.) Women with Adequate GWG (AGWG; women with normal pre-pregnancy BMI, gaining from 11.5 Kg to 16 Kg during pregnancy); ii.) Women with Excessive GWG (EGWG; women with pre-pregnancy BMI indicating overweight or obesity, gaining more than 11.5 Kg or 9 Kg during pregnancy, respectively); and iii.)Women with Low GWG (LGWG; women with low pre-pregnancy weight status, gaining less than 12.5 Kg).
Measured: GWG will be evaluated at T2 (1 month after delivery)

Secondary outcomes (4)

Nutritional aspects evaluation during pregnancy and lactation
Evaluation of the LEI program effectiveness on nutritional aspects. In particular, maternal adherence to the Mediterranean Diet as well as maternal nutritional knowledge will be assessed by meaning of previously validated questionnaires at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).
Measured: Nutritional aspects will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).
Physical activity evaluation during pregnancy and lactation
Evaluation of the LEI program effectiveness on physical activity. In particular, to investigate physical activity patterns, a section of a previously developed and validated questionnaire on an Italian youth population was adapted and administered to our adult participants by deleting physical activities in the school environment. This adapted version was also pre-tested on a sample of 24 subjects and revised accordingly. All answers were structured to quantify the time spent weekly in physical activity, including the activities spent during free time and screen time. The questionnaire was composed of 5 multiple-choice questions that followed a Likert scale format comprising 4 choices ("Always", "Often", "Sometimes", and "Never") corresponding to a score between 0 to 3, where the highest score suggested the healthiest habit.
Measured: Physical activity will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).
Smoking habits during pregnancy and lactation
Evaluation of the LEI program effectiveness on smoking habits. In particular, smoking habits will be monitored through interviews, and the number of smoked cigarette packs per year will be documented. Participants will be categorized as those who had never smoked, quit smoking before or during pregnancy, or started or kept smoking during pregnancy and/or lactation.
Measured: Smoking habits will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).
Maternal attitude towards infant feeding.
The Iowa Infant Feeding Attitude Scale (IIFAS) was used to assess the maternal attitude towards infant feeding methods and to predict breastfeeding intention and exclusivity. In brief, the IIFAS is a standardized interview questionnaire on participants' characteristics and habits (age, residence, education, self-assessed socioeconomic status, relationship status, work before pregnancy, back to work after maternity leave, mode of delivery, parity, way of feeding previous babies, planned way of feeding this newborn)
Measured: Maternal attitude towards infant feeding will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T2, 4 weeks after the delivery).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202430 Nov 2025

First posted16 Feb 2024
Study start15 Mar 2024 (estimated)
Primary completion15 May 2025 (estimated)
Study completion30 Nov 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Non-randomised
Intervention model: Parallel groups
Model description: Quasi-experimental - controlled, non-randomized pilot study
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06264349
Sponsor's protocol ID: 05102023
Acronym: MATER
Status last verified: Feb 2024
First submitted: 5 Oct 2023
Last updated: 16 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Hellas Cena, Prof

+390382987542

hellas.cena@unipv.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Women and Maternity: Development of a Nutritional Education Project
ClinicalTrials.gov ID: NCT06264349
Acronym / sponsor ID: MATER / 05102023
Conditions: Pregnancy, Lactation
Keywords: Lifestyle, Health, First one-thousand days, Dietary habits
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: University of PaviaUniversity, hospital or other
Study start: 15 Mar 2024 (estimated)
Primary completion: 15 May 2025 (estimated)
Study completion: 30 Nov 2025 (estimated)
First posted: 16 Feb 2024 (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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Quasi-experimental - controlled, non-randomized pilot study

Arm	Type	Receives
Group A: frontal lessons	Experimental	Other: Lifestyle Educational Intervention50 women will receive a Lifestyle Educational Intervention (LEI) from research staff regarding a correct lifestyle during pregnancy and lactation through 6 interactive online lectures lasting approximately 30 minutes each.
Group B: web-mobile app	Experimental	Other: Lifestyle Educational Intervention50 women will receive Lifestyle Educational Intervention (LEI) from research staff regarding a correct lifestyle during pregnancy and lactation through a digital tool (web-mobile app), previously developed.
Control Group	No intervention	–50 women of the same age as the intervention group will be selected within the LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children (LIMIT) project cohort. The LIMIT protocol is registered on clinicaltrials.gov (NCT04960670)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

age ≥ 18 years;
first trimester;
parents' ability to speak and understand the Italian language;
parents' ability to sign the informed consent and to fill in the questionnaires

Key exclusion criteria (2 listed)

age < 18 years;
diagnosis of chronic and/or eating disorders

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 Educational InterventionAlso: LEIThe Lifestyle Educational Intervention (LEI) consists of promoting a healthy lifestyle during pregnancy and breastfeeding. In particular, the contents concern: i). macro- and micronutrient requirements during pregnancy/breastfeeding; ii). definition of the concept of the food pyramid and healthy plate also considering aspects of food sustainability; iii). definition of the principles of food safety during pregnancy; iv). importance of maternal and infant sleep quality; v). importance of maternal physical activity during pregnancy and lactation; vi). psychological aspects regarding the mother-child dyad.	Other	Group A: frontal lessons, Group B: web-mobile app

Primary outcome

Gestational weight gain management
Time frame: GWG will be evaluated at T2 (1 month after delivery)
Evaluation of the LEI program effectiveness on gestational weight gain (GWG) management. GWG (Kg) will be calculated retrospectively as the difference between the weight at the first and last prenatal visit, just before delivery. Based on that, women will be classified into 3 categories, according to the IOM (U.S.) and the National Research Council (U.S.) Committee to Reexamine IOM Pregnancy Weight Guidelines, as follow: i.) Women with Adequate GWG (AGWG; women with normal pre-pregnancy BMI, gaining from 11.5 Kg to 16 Kg during pregnancy); ii.) Women with Excessive GWG (EGWG; women with pre-pregnancy BMI indicating overweight or obesity, gaining more than 11.5 Kg or 9 Kg during pregnancy, respectively); and iii.)Women with Low GWG (LGWG; women with low pre-pregnancy weight status, gaining less than 12.5 Kg).

4 secondary outcomes

Nutritional aspects evaluation during pregnancy and lactation
Time frame: Nutritional aspects will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).
Physical activity evaluation during pregnancy and lactation
Time frame: Physical activity will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).
Smoking habits during pregnancy and lactation
Time frame: Smoking habits will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).
Maternal attitude towards infant feeding.
Time frame: Maternal attitude towards infant feeding will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T2, 4 weeks after the delivery).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
Project funded by the National Recovery and Resilience Plan (NRRP), ONFOOD Research Project, Spoke 5 - Lifelong and Nutrition.Link provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Hellas Cena, Prof contact

+390382987542

hellas.cena@unipv.it

Rachele De Giuseppe, PhD contact

+390382987544

rachele.degiuseppe@unipv.it

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Educational Intervention in people with Pregnancy and Lactation, run by University of Pavia.

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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hellas Cena, Prof (+390382987542, hellas.cena@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational weight gain management (time frame: GWG will be evaluated at T2 (1 month after delivery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06264349.

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 16 Feb 2024.