Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Supporting MumS (SMS) multisite, parallel-group, randomised controlled trial.

INTRODUCTION: The reproductive years can increase women's weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development. METHODS AND ANALYSIS: Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m2 and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m2), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost-utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants' experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation. ETHICS AND DISSEMINATION: Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences. TRIAL REGISTRATION NUMBER: ISRCTN16299220.

Exploring the world of food with families: perspectives of low-income families on factors influencing their food choices.

OBJECTIVE: The aim of this study was to investigate the social and environmental factors involved in the food decision-making processes of families living on lower incomes on the Island of Ireland. DESIGN: A qualitative design was employed for this study, using photovoice and creative mapping methods. Parents were requested to take photos and draw maps of their food environments. Interviews were then conducted with parents, using the materials produced by parents as a cue to discuss their food environments, influences and decision-making processes around food choices. SETTING: The participants were interviewed online via Microsoft Teams. PARTICIPANTS: The participants were parents or guardians of children between the ages of 2 and 18 who self-defined as 'living on a tight budget'. RESULTS: Twenty-eight participants were recruited and interviewed for this study, including twelve parents in Northern Ireland and sixteen in the Republic of Ireland. The findings were mapped on to Bronfenbrenner's Ecological Systems Theory and showed that multiple, overlapping and intersecting factors at the individual, micro-, meso-, exo-, macro- and chrono-system were implicated in family food choices. Upstream factors in particular, including structural, policy and commercial determinants, appear to be significant drivers of behaviour. CONCLUSIONS: While the findings suggest that a complex range of factors are involved in family food choices, it is clear that policy measures and regulations are needed to stave off the impacts of rising social inequality and food poverty. Health promoters should strive to find non-stigmatising interventions to bridge the nutritional divide experienced by lower-income families.

Using Online Photovoice to Explore Food Decisions of Families on Low Income: Lessons Learnt During the COVID-19 Pandemic.

The method of photovoice has been previously used to effectively engage with socioeconomically disadvantaged groups and explore their eating behaviours. In this methodological article, we draw on our experiences from using photovoice through online interviews with families on low income about their food decisions. A purposive recruitment approach targeted parents of children 2-17 years old who lived on a tight budget across the island of Ireland. Participants provided demographic information and were invited to take photographs of food-related decisions and activities for 1 week during the COVID-19 lockdown. The photographs were then discussed through an online communication platform to generate qualitative data. A total of 28 parents participated in the photo-elicited interviews and shared a total of 642 photographs of factors that influenced their food decisions. Following the interviews, the researchers documented their reflections which focused on (1) participants' engagement with the online photo-elicitation and (2) practical aspects around participant consent and data safety. The participants in our study engaged well with the online photovoice method and shared a variety of photos which provided ample material to facilitate the conversations around their food environment and its impact on their food decisions. Our experiences can provide novel insights into using photovoice in a virtual environment and useful considerations around ethics and data collection for researchers who work with socioeconomically disadvantaged groups. Photo-elicited interviews offer an engaging and flexible data collection technique that can highlight issues informing future priorities of healthcare policy.

Public beliefs about the consequences of living with obesity in the Republic of Ireland and Northern Ireland.

BACKGROUND: This study aimed to capture public beliefs about living with obesity, examine how these beliefs have changed over time and to explore whether certain characteristics were associated with them in a nationally representative sample of adults from the Republic of Ireland (RoI) and Northern Ireland (NI). METHODS: A cross-sectional survey employed a random quota sampling approach to recruit a nationally representative sample of 1046 adults across NI and RoI. Telephone interviews captured information on demographics; health behaviours & attitudes; and beliefs about the consequences of obesity (measured using the Obesity Beliefs Scale). Univariable analyses compared beliefs about the consequences of living with obesity between participants with a self-reported healthy weight and those living with overweight or obesity, and non-responders (those for whom weight status could not be ascertained due to missing data). Multiple linear regression examined associations between obesity-related beliefs and socio-demographics, self-rated health and perceived ability to change health behaviours. Multiple linear regression also compared changes in obesity-related beliefs between 2013 and 2020 in the RoI. RESULTS: Higher endorsement of the negative outcomes of obesity was significantly associated with living with a healthy weight, higher self-rated health, dietary quality and perceived ability to improve diet and physical activity. Those who lived with overweight, with obesity and non-responders were less likely to endorse the negative consequences of obesity. Those living with obesity and non-responders were also more likely to support there is an increased cost and effort in maintaining a healthy weight. Comparison with survey data from 2013 showed that currently, there is a greater endorsement of the health benefits of maintaining a healthy weight (p < 0001), but also of the increased costs associated with it (p < 0001). CONCLUSION: Beliefs about the consequences of maintaining a healthy body weight are associated with individuals' weight, self-rated health, diet and perceived ease of adoption of dietary and exercise-related improvements. Beliefs about the health risks of obesity and perceived greater costs associated with maintaining a healthy weight appear to have strengthened over time. Present findings are pertinent to researchers and policy makers involved in the design and framing of interventions to address obesity.

An online survey of dietary quality during complementary feeding; associations with maternal feeding self-efficacy and adherence to dietary recommendations.

BACKGROUND: Parents are the gatekeepers of nutrition in early life and their feeding practices form children's dietary behaviours. Although maternal characteristics have been associated with certain feeding practices, their relationship with overall quality of complementary feeding diets has not been explored. This study aimed to: assess dietary quality in complementary feeding age; explore its association with maternal and child characteristics; and evaluate the association between complementary feeding practices and child weight. METHODS: An online cross-sectional survey captured data from a self-selected sample of mothers living in the UK with a healthy full-term child in complementary feeding age. A total of 466 mothers completed a questionnaire on their complementary feeding practices, demographics, anthropometrics, rates of maternal food neophobia, feeding self-efficacy, social support, postnatal depression and infant temperament. Dietary quality was assessed using the Complementary Feeding Utility Index (CFUI). Children were classified into underweight, normal weight, overweight and obese. RESULTS: Majority of participants reported high levels of dietary quality as determined by a mean CFUI score of 80%. High dietary quality was associated with reliance on the NHS recommendation on timing of complementary feeding and maternal self-efficacy in promoting a healthy diet and limiting non-recommended foods. Responsive feeding, longer breastfeeding duration, frequent exposure to fruits and to a high variety of protein-rich animal foods were significantly associated with lighter child weight status. Consumption of sweetened drinks and delayed introduction of lumpy foods were associated with heavier child weight status. CONCLUSIONS: This study provided an evaluation of dietary quality in complementary feeding in a UK sample of children and explored its relationship with maternal and child attributes. Increasing understanding of the current complementary feeding recommendations and strengthening maternal feeding self-efficacy may be key for healthcare professionals and researchers to improving complementary feeding practices.

Parental perceptions of the food environment and their influence on food decisions among low-income families: a rapid review of qualitative evidence.

BACKGROUND: The food environment within and surrounding homes influences family dietary habits with socio-economic areas at a nutritional disadvantage. Families' perception of the food environment and how it influences their food decisions is less clear. This rapid review aimed to synthesise qualitative evidence of parental perspectives of the food environment and their influence on food decisions among disadvantaged families. METHOD: Qualitative and mixed-methods peer-reviewed journal articles published after 2000, that explored the perspectives of low-income parents in relation to their food environment and how this impacted food decisions for families with children aged 2-17 years, were included in this review. Embase, Scopus and PsycINFO were the databases chosen for this review. Search strategies included seven concepts related to family, food, perceptions, influences, environment, socio-economic status and study type. Two independent reviewers screened sixty-four studies. Thematic synthesis was employed. RESULTS: Two thousand one hundred and forty five results were identified through database searching and 1,650 were screened. Fourteen articles that originated from the US, Australia and the UK were included in this review. No articles were excluded following quality appraisal. Child preferences, financial and time constraints, and location and access to food outlets were barriers to accessing healthy food. Parental nutrition education and feeding approaches varied but positive outcomes from interventions to address these behaviours will be short-lived if inequities in health caused by poverty and access to affordable and healthy food are not addressed. The reliance on social support from families or government sources played an important role for families but are likely to be short-term solutions to health and nutritional inequities. CONCLUSIONS: This qualitative evidence synthesis provides an insight into the perceptions of low-income parents on the factors influencing food decisions. Findings have implications for public health and the development of effective strategies to improve the dietary habits of children of disadvantaged families. Sustainable changes to dietary habits for families on low-income requires policy responses to low income, food access and to the high cost of healthy foods.

A qualitative exploration of the impact of COVID-19 on food decisions of economically disadvantaged families in Northern Ireland.

BACKGROUND: The first UK-wide lockdown to prevent the spread of COVID-19 had a serious financial impact on low-income households, a population already in higher risk of food insecurity and poor dietary choices. Qualitative data on the impact of COVID-19 lockdown on food decisions of UK families are scarce. This study aimed to explore how the measures to control the spread of COVID-19 influenced the food-related decisions of socioeconomically deprived families in Northern Ireland. METHODS: A qualitative study captured data from online individual interviews. Participation was open for parents of children 2-17 years old living on a tight budget in urban and rural areas of Northern Ireland. A sampling matrix enabled equal representation of single- and two-parent households, as well as parents of younger children (<12y) and adolescents (≥12y). Data were collected by using the methods of Photovoice and mapping exercise. Data were analysed through a thematic approach. RESULTS: Twelve online interviews were conducted and five distinct themes were identified reflecting families' food-related decisions that were affected by the COVID-19 lockdown: 1) food planning; 2) food purchasing; 3) meal preparation; 4) eating and feeding behaviours and 5) eating food prepared outside the house. CONCLUSIONS: The restrictions put in place to inhibit the spread of COVID-19 influenced all aspects of dietary decisions of low-income families. Changes observed during this period included frequent consumption of homemade meals, but also increased unhealthy snacking. Infrequent food shopping encouraged good meal planning, but was also a barrier to securing adequate fresh food. Food-related support including school meal assistance contributed to families' food security, particularly those of single parents.

Recruiting 'hard to reach' parents for health promotion research: experiences from a qualitative study.

OBJECTIVE: Marginalised populations are less likely to take part in health research, and are sometimes considered 'easy to ignore'. We aimed to describe our approach and results of recruiting parents who experience disadvantage, for focus groups exploring infant feeding on the island of Ireland. Upon receiving ethical approval, we implemented recruitment strategies that included building rapport with community organisations through existing networks, targeting specific organisations with information about our aims, and utilising social media groups for parents. RESULTS: We approached 74 organisations of which 17 helped with recruitment. We recruited 86 parents/carers (one male) for 19 focus groups (15 urban/4 rural). Seventy two percent met at the eligibility criteria. Most participants were recruited through organisations (91%), and the remainder on social media (9%). Recruitment barriers included multiple steps, research fatigue, or uncertainty around expectations. Factors such as building rapport, simplifying the recruitment process and being flexible with procedures were facilitators. Despite comprehensive, multi-pronged approaches, the most marginalised parents may not have been reached. Further alternative recruitment strategies are required for recruiting fathers, rural populations, or those without the capacity or opportunity to engage with local services.

Parental considerations during complementary feeding in higher income countries: a systematic review of qualitative evidence.

OBJECTIVE: Worldwide data suggest a clash between parental complementary feeding practices and recommendations. Understanding the circumstances under which parents form their feeding practices is a crucial step to improve such practices. This paper aimed to systematically review the existing qualitative literature and synthesise the factors that parents take into consideration in relation to complementary feeding. DESIGN: A systematic review was undertaken. Four electronic databases were searched for qualitative studies published after 2001 exploring parental experiences during complementary feeding. A framework that included authors' outcomes of interest was used to extract and synthesise study findings. The Standards for Reporting Qualitative Research were used to critically assess the included studies. SETTING: Upper-middle- and high-income countries. PARTICIPANTS: Parents with a child below the age of 3 years. RESULTS: A total of forty-seven studies met the eligibility criteria and were included in this systematic review. The themes were organised into three main categories: (1) factors related to introduction of complementary foods; (2) factors related to the type of complementary foods and (3) factors related to both timing and type. The selected literature highlights: prevalent baby cues that prompt parents to introduce solid foods; parents' views on the recommended timing of complementary feeding; factors that drive the choice of complementary foods and perceived value in advice received from health professionals and grandmothers. CONCLUSIONS: This systematic review indicates factors that can be barriers to complying with the complementary feeding guidelines, and therefore, its findings are pertinent to improving parental feeding practices through intervention studies and through infant feeding education in a primary care setting.

Comparing Maternal and Paternal Complementary Feeding Practices: Findings From an Online Survey.

OBJECTIVE: To explore differences between mothers' and fathers' complementary feeding practices. METHODS: An online survey of UK parents with a healthy child in complementary feeding age. Timing of introducing solid foods and adherence to feeding guidelines were assessed. Dietary quality was measured using the Complementary Feeding Utility Index. RESULTS: In a sample of 60 mothers and fathers (nondyads), there were no differences between fathers and mothers in the timing of introduction of solid foods, compliance with complementary feeding guidelines, or dietary quality. Most fathers who participated had a male child, whereas mothers had an equal number of male and female children (P < 0.001). The proportion of mothers who followed baby-led weaning was higher compared with fathers (P = 0.02). CONCLUSIONS AND IMPLICATIONS: Study findings reveal no gender differences in parental complementary feeding practices apart from the use of baby-led weaning. Future studies with bigger male samples are warranted to explore the paternal role during complementary feeding.

Micronutrient dietary intakes and their food sources in adults: the Hellenic National Nutrition and Health Survey (HNNHS).

BACKGROUND: The present study aimed to assess micronutrient intake among Greek adults and to identify the main food sources that contribute to it. METHODS: Food consumption data from 2389 participants in the Hellenic National Nutrition and Health Survey (HNNHS), collected with 24-h recalls, was used to calculate micronutrient intakes. Usual nutrient intake was estimated according to the National Cancer Institute method. Nutrient adequacy was estimated using the estimated average requirement (EAR) cut-point method, when available, or adequate intake otherwise. The probability approach was used to determine iron intake adequacy in females of reproductive age. Food group contribution for each nutrient assessed was derived to identify their main food sources. RESULTS: Almost all individuals had vitamin D intake below EAR, whereas vitamins A, E, K and C, as well as potassium intake, were also insufficient in a considerable percentage of the population (>70% in most age groups). Calcium intake was substantially below the EAR for females aged >50 years and males >70 years; the same for magnesium in males >70 years. Furthermore, 50% of females, including those of reproductive age, had intake of folate below EAR. More than 50% of the population (to 79%) exceeded the upper tolerable limit for sodium (2300 mg day-1 ). Food contribution analysis revealed that most vitamins were derived from low-quality foods (i.e. fast-food). CONCLUSIONS: A significant proportion of adults residing in Greece have low nutrient intake and poor food selections. These results provide guidance to public health policy makers for developing strategies to improve the dietary quality in Greece.

Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial.

BACKGROUND: Pregnant women with metabolic risk factors are at high risk of complications. We aimed to assess whether a Mediterranean-style diet reduces adverse pregnancy outcomes in high-risk women. METHODS AND FINDINGS: We conducted a multicentre randomised trial in 5 maternity units (4 in London and 1 in Birmingham) between 12 September 2014 and 29 February 2016. We randomised inner-city pregnant women with metabolic risk factors (obesity, chronic hypertension, or hypertriglyceridaemia) to a Mediterranean-style diet with high intake of nuts, extra virgin olive oil, fruits, vegetables, nonrefined grains, and legumes; moderate to high consumption of fish; low to moderate intake of poultry and dairy products; low intake of red and processed meat; and avoidance of sugary drinks, fast food, and food rich in animal fat versus usual care. Participants received individualised dietary advice at 18, 20, and 28 weeks' gestation. The primary endpoints were composite maternal (gestational diabetes or preeclampsia) and composite offspring (stillbirth, small for gestational age, or admission to neonatal care unit) outcomes prioritised by a Delphi survey. We used an intention-to-treat (ITT) analysis with multivariable models and identified the stratification variables and prognostic factors a priori. We screened 7,950 and randomised 1,252 women. Baseline data were available for 593 women in the intervention (93.3% follow-up, 553/593) and 612 in the control (95.6% follow-up, 585/612) groups. Over a quarter of randomised women were primigravida (330/1,205; 27%), 60% (729/1,205) were of Black or Asian ethnicity, and 69% (836/1,205) were obese. Women in the intervention arm consumed more nuts (70.1% versus 22.9%; adjusted odds ratio [aOR] 6.8, 95% confidence interval [CI] 4.3-10.6, p ≤ 0.001) and extra virgin olive oil (93.2% versus 49.0%; aOR 32.2, 95% CI 16.0-64.6, p ≤ 0.001) than controls; increased their intake of fish (p < 0.001), white meat (p < 0.001), and pulses (p = 0.05); and reduced their intake of red meat (p < 0.001), butter, margarine, and cream (p < 0.001). There was no significant reduction in the composite maternal (22.8% versus 28.6%; aOR 0.76, 95% CI 0.56-1.03, p = 0.08) or composite offspring (17.3% versus 20.9%; aOR 0.79, 95% CI 0.58-1.08, p = 0.14) outcomes. There was an apparent reduction in the odds of gestational diabetes by 35% (aOR 0.65, 95% CI 0.47-0.91, p = 0.01) but not in other individual components of the composite outcomes. Mothers gained less gestational weight (mean 6.8 versus 8.3 kg; adjusted difference -1.2 Kg, 95% CI -2.2 to -0.2, p = 0.03) with intervention versus control. There was no difference in any of the other maternal and offspring complications between both groups. When we pooled findings from the Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes (ESTEEM) trial with similar trials using random effects meta-analysis, we observed a significant reduction in gestational diabetes (odds ratio [OR] 0.67, 95% CI 0.53-0.84, I2 = 0%), with no heterogeneity (2 trials, 2,397 women). The study's limitations include the use of participant reported tools for adherence to the intervention instead of objective biomarkers. CONCLUSIONS: A simple, individualised, Mediterranean-style diet in pregnancy did not reduce the overall risk of adverse maternal and offspring complications but has the potential to reduce gestational weight gain and the risk of gestational diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02218931.

"The One Time You Have Control over What They Eat": A Qualitative Exploration of Mothers' Practices to Establish Healthy Eating Behaviours during Weaning.

BACKGROUND: Weaning marks the transition from a milk-only diet to the consumption of solid foods. It is a time period where nutrition holds an undeniable importance and taste experiences have a long-lasting effect on food preferences. The factors and conditions that form parental feeding practices are yet to be fully understood; doing so can help target problematic behaviours and develop interventions aiming to modify them. OBJECTIVE: This study used a qualitative methodology to gain a better understanding of parental experiences of weaning a child. Particular emphasis was placed on exploring the factors and conditions that favour the establishment of a healthy relationship with food in infancy and those that impede it. METHODS: Thirty-seven mothers of healthy infants 3⁻14 months with no previous history of allergies or food-related disorders were recruited. Eight semi-structured focus group discussions were conducted, transcribed and analysed thematically. RESULTS: Discussions revealed a number of opportunities to establish healthy eating habits during weaning, as well as relevant challenges. Important opportunities included: acting as a role model for healthy foods; giving multiple opportunities to try a food; food variety "so you don't have a fussy eater"; and without food variety "things aren't going to work properly". Additionally, some of the challenges identified were: misconceptions about the definition of food variety; and distractions occurring during feeding. CONCLUSIONS: Mothers were mindful of the need to provide their children with appropriate nutritional stimuli during weaning. They were aware of their role in influencing their infants' likes and used strategies such as modelling and repeated food exposure. The importance of a diverse diet in infancy was acknowledged, although knowledge gaps exist in relation to its definition. Distractions were tactfully employed by mothers to assist feeding. Findings of this study have applications in developing interventions for nutritional education in the complementary feeding period.

Solid advice: Complementary feeding experiences among disadvantaged parents in two countries.

The initiation of complementary feeding (CF; introducing infants to food/drink other than milk) is recommended close to 6 months and not before 4 months of age. Low socio-economic status (SES) is a determinant of nonadherence to CF recommendations, but there is an evidence gap around reasons for nonadherence among these parents. This study investigated knowledge, attitudes, and practices of disadvantaged families (in terms of SES and social support) and use of guidance for CF, in the Republic of Ireland and Northern Ireland. Parents of infants aged 3-14 months were recruited via community groups. Semistructured focus groups aided by vignettes were used. Data were analysed using an inductive thematic approach. Nineteen focus groups took place with parents (n = 83). A range of factors influence parents when introducing solids. Sources of guidance extend to family, friends, the internet, and commercial resources. Parents experience uncertainty and anxiety during this time, driven by lack of knowledge and conflicting advice. Five major themes were identified: (a) more guidance that is accessible, timely, and respectfully needed; (b) the challenge of choosing safe, nutritious food; (c) "everybody has an opinion"; (d) feelings of inadequacy, embarrassment, and guilt; and (e) decisions are ultimately based on individual circumstances. CF advice should be culturally appropriate, practical, and empowering, emphasising the rationale behind updates to recommendations and consequences of nonadherence. Future training of health professionals for delivery of CF advice and guidance should consider these findings. Compliance with CF recommendations is influenced by health professionals, the wider family, and the commercial baby-food sector.

Mediterranean diet based intervention in pregnancy to improve maternal and fetal outcomes: Methodological challenges and lessons learned from the multicentre ESTEEM study.

INTRODUCTION: Evaluating complex dietary interventions such as Mediterranean diet in pregnancy presents unique methodological challenges. We present the challenges and the lessons learned from a multicentre randomised trial (ESTEEM) on Mediterranean-based dietary intervention in pregnancy. METHODS: We recruited pregnant women who met our predefined inclusion criteria and randomised those with metabolic risk factors to the Mediterranean-based dietary intervention or routine antenatal care. We evaluated the effect of the ESTEEM intervention on composite maternal and fetal outcomes. CHALLENGES AND SOLUTIONS: The main challenges were encountered in recruiting to ESTEEM, delivering the intervention, engaging clinical staff, assessing adherence and choosing the outcome measures. The large sample size coupled with the slow recruitment rate forced us to extend the recruitment period by 4 months. The limitation in available resources was overcome by opening sites in a step-wise approach. Engaging healthcare providers was promoted by embedding the recruitment and the follow-up activities into current clinical practice, and promoting research skills training. We delivered the intervention early on in the pregnancy to promote the dietary effect on healthy placentation and reduce metabolic risk factors. Participants and their families were actively involved in the dietary intervention to improve adherence through a series of group teaching sessions. A user-friendly short dietary questionnaire was developed and validated to assess adherence to the intervention. The trial composite primary outcome was chosen in consensus based on input from a panel of experts. CONCLUSION: The ESTEEM experience offers an insight into future pragmatic nutritional studies in pregnancy. TRIAL REGISTRATION NUMBER: NCT02218931.

Effect of simple, targeted diet in pregnant women with metabolic risk factors on maternal and fetal outcomes (ESTEEM): study protocol for a pragmatic multicentre randomised trial.

INTRODUCTION: Women with metabolic risk factors are at higher risk of adverse pregnancy outcomes. Mediterranean-based dietary interventions have the potential to minimise these risks. We aim to evaluate the effectiveness of a simple, targeted intervention modelled on Mediterranean diet in preventing maternal and fetal complications in pregnant women with metabolic risk factors. METHODS AND ANALYSIS: Pregnant women with a singleton pregnancy <18 weeks gestation, and without pre-existing diabetes, chronic renal disease and autoimmune diseases will be recruited. Women with metabolic risk factors will be randomised to receive a dietary intervention based on a Mediterranean pattern, supplemented with extra virgin olive oil and mixed nuts until delivery. The intervention will be delivered through a series of one to one and group sessions. The primary outcome is a composite maternal outcome of pre-eclampsia or gestational diabetes and a composite fetal outcome of stillbirth, small for gestational age fetus or admission to the neonatal intensive care unit. Secondary outcomes include maternal, fetal, dietary and laboratory outcomes. We aim to randomise 1230 eligible women with metabolic risk factors. We will also compare the outcomes in women with and without these risk factors. The sample size will provide us with 80% power at 5% significance, assuming a 20% loss to follow-up to detect a 30% reduction in maternal and fetal complications. ETHICS AND DISSEMINATION: The ESTEEM trial is designed to provide a definitive estimate of the effects of Mediterranean dietary pattern in pregnancy on maternal and fetal outcomes. The pragmatic nature of ESTEEM ensures the applicability of its findings into clinical practice. The findings of the study will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the NHS Research Ethics Committees (14/EE/1048). TRIAL REGISTRATION NUMBER: NCT02218931; Pre-results.