Mathilde Touvier, Dr

Pilar Galan, Dr

Serge Hercberg, Pr

Emmanuelle Kesse-Guyot, Dr

Sandrine Péneau, Dr

Léopold Fezeu, Dr

Chantal Julia, Dr

Valentina Andreeva, Dr

Allès Benjamin, Dr

Baudry Julia, Dr

Deschasaux Mélanie, Dr

The NutriNet-Santé study was set up to investigate nutrition and health relationships. Specifically, it was the first web-based cohort worldwide on such a large scale (n=171 000 as of 2021) focused on the complex link between nutrition and health status. It is characterized by a very detailed assessment of nutritional exposure and dietary behavior.

https://etude-nutrinet-sante.fr/ https://info.etude-nutrinet-sante.fr/en

NutriNet-Santé is a large-scale (n=171,000) web-based cohort coordinated by EREN, launched in France in 2009 to investigate nutrition and health relationships. All required ethics authorisations have been obtained (listed here). NutriNet-Santé participants regularly fill questionnaires through a dedicated and secure website, providing extensive, high-quality nutritional and non-nutritional data, including repeated data on socio-demographics and lifestyle (yearly), anthropometrics (every 6 months), dietary intake (every 6 months), physical activity (IPAQ questionnaire, yearly)5 and health status (every 6 months). NutriNet-Santé is characterised by a very detailed and up-to-date assessment of nutritional exposure and dietary behaviours. Usual dietary intakes are assessed at baseline and every 6 months thereafter through a series of 3 non-consecutive randomly assigned 24h dietary records. Daily energy, alcohol, micro- and macronutrient intakes are calculated using the published NutriNet-Santé food composition database (\>3,500 generic items). All major health events (e.g., cancers, cardio- and cerebrovascular diseases) are reported by the participants and validated by an expert committee of physicians based on medical records, and/or retrieved from the French National Health Insurance medico-administrative databases to limit potential reporting bias. In turn, mortality data are obtained from the exhaustive French National Mortality Registry (CépiDC). The number of incident events already registered is as follows: 4,200 cancers and 1,240 deaths. A sub-sample of the cohort (n=20,000) provided blood and urine samples, currently stored at -80°C in EREN's biobank.

Samples of serum, plasma, and buffy-coats (for genetic analyses), as well as urine samples was set up for 19 600 subjects of the cohort.

The NutriNet-Santé Study

The NutriNet-Santé Study. A Web-based Prospective Cohort Study of the Relationship Between Nutrition and Health and of Dietary Patterns and Nutritional Status Predictors

self reported though validated scales and/or questionnaires

combination of previsously listed mental and physical health outcomes

Institut National de la Santé Et de la Recherche Médicale, France

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Conservatoire national des Arts et Métiers

University of Paris 13

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Integrated intervention of smoking cessation and breastfeeding

Instructions on general pregnancy and infant care

The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.

Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

Attention placebo control

Xiaozhong Wen, MD, PhD

This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.

The investigators are proposing the first randomized controlled trial to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their 1st or 2nd trimester of pregnancy (≤28 weeks) from local obstetric clinics, communities, and social media. They will be randomized into either the intervention (N=20) or control group (N=20). The two groups will complete the same number of sessions (6 during pregnancy and 3 postpartum), but focus on different topics. Specifically, the control group will receive instructions on general pregnancy and infant care. The intervention group will receive instructions on general pregnancy and infant care, plus an integrated multicomponent intervention that promotes both smoking cessation and breastfeeding (i.e., education and counseling, monitoring and feedback, and contingent financial incentives). Two female Certified Lactation Counselors (interventionists) will be trained to run study sessions during home visits. Interventionists will provide additional support via phone and text messaging until 6 months postpartum. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum within the duration of this award.

The 40 eligible participants will be randomized into either the intervention (N=20) or control group (N=20). A sequence of random numbers in blocks of 2 will be used to ensure equal numbers of participants for each group over time.

Research staff who collect and analyze outcome data will be blinded to participants' group assignments.

Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding

Based on their recorded daily numbers of cigarettes and cigars smoked after enrollment, the investigators will classify smoking abstinence status in the past 7 days (7-day point-prevalence).60,61 The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (\<50 ng/mL).

During pregnancy, participants will report breastfeeding intention using questionnaires modified from the Infant Feeding Practices Study II.

During postpartum, mothers will report breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum.

During postpartum, mothers will report breastfeeding frequency (times per day) every month until 6 months postpartum.

During postpartum, mothers will update breastfeeding duration (weeks) every month until 6 months postpartum.

During postpartum, mothers will update formula duration (weeks) every month until 6 months postpartum.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The NutriNet-Santé Study	NCT03335644	Diet, Food, and... Exercise Diseases Catego... Cohort Studies Adult Anthropometry Humans Internet Surveys and Que... Mortality		15 Years -	University of Paris 13
The NutriNet-Santé Study	NCT03335644	Diet, Food, and... Exercise Diseases Catego... Cohort Studies Adult Anthropometry Humans Internet Surveys and Que... Mortality		15 Years -	University of Paris 13
Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding	NCT05123118	Smoking, Cigare... Breastfeeding	Integrated inte... Attention place...	18 Years -	State University of New York at Buffalo

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