Designing Mobile Phone Text Messages Using the Behavior Change Wheel Framework to Influence Food Literacy in Adults With Type 2 Diabetes in Kenya: Protocol for a Systematic Development Study.

BACKGROUND: The worldwide prevalence of type 2 diabetes (T2D) has increased in the past decade, and it is projected to increase by 126% by 2045 in Africa. At the same time, mobile phone use has increased in Africa, providing a potential for innovative mobile health interventions to support diabetes care. OBJECTIVE: This study aimed to apply the Behavior Change Wheel (BCW) framework to develop text messages to influence food literacy in adults with T2D in urban Kenya. METHODS: The 8 steps of the BCW framework guided the development of text messages: (1) Define the problem in behavioral terms; (2) select target behaviors; (3) specify the target behaviors based on who needs to perform the behaviors, what needs to change, and when, where, how often, and with whom; (4) identify what needs to change; (5) identify intervention functions; (6) select policy categories; (7) select behavior change techniques (BCTs); and (8) select the mode of delivery. Recent exploratory studies in Kenya and other low- and middle-income countries provided information that was used to contextualize the intervention. RESULTS: In step 1, the behavioral problem was defined as unhealthy dietary patterns among adults with T2D. In step 2, based on a qualitative study in the target population, the target behavior was selected to be evaluation of reliable sources of information, and selection and preparation of healthy food. In step 3, unhealthy dietary patterns were selected. In step 4, 10 domains of the Theoretical Domains Framework were identified, and in step 5, 5 intervention functions were linked to the domains and unhealthy dietary patterns were specified. In step 6, communication and regulations were identified as policy categories, while in step 7, 9 BCTs were selected from the Behavior Change Technique Taxonomy version 1. In step 8, the most suitable mode of delivery was determined to be mobile text messages. A total of 36 mobile text messages were developed based on the 9 BCTs. CONCLUSIONS: This study shows the step-by-step application of the BCW framework to develop mobile text messages to influence food literacy in adults with T2D. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/48271.

Belgian Fertility Clinic Staff Value Healthy Lifestyle Promotion but Lack Access to a Structured Lifestyle Modification Programme: An Observational Study.

OBJECTIVES: Guidelines advise promoting a healthy lifestyle among patients with fertility problems as the lifestyle of women and men proved to be associated with their fertility. Australian fertility nurses were shown to lack access to structured lifestyle modification programmes, although they value healthy lifestyle promotion. This study aimed to examine whether gynaecologists also value promoting a healthy lifestyle and whether structured lifestyle modification programmes are available in Belgian fertility clinics. DESIGN: An observational study was conducted among health care professionals (HCPs) working in Belgian fertility clinics. PARTICIPANTS/MATERIALS, SETTING, METHODS: An Australian questionnaire on attitudes and practices related to promoting a healthy lifestyle among patients with fertility problems was reciprocally back-to-back translated and three open-ended questions were added. All HCPs of Belgian fertility clinics, including gynaecologists, fertility nurses/midwives, psychologists, and embryologists, were invited by e-mail to complete the questionnaire online. Responses to closed and open-ended questions were analysed with, respectively, descriptive statistics and qualitative thematic analysis. Finally, differences in perspectives between different groups of HCPs were explored. RESULTS: A total of 50 fertility nurses/midwives, 42 gynaecologists, and 19 other HCPs completed the survey (n = 111). Regarding attitudes, all respondents valued informing patients about the impact of lifestyle on fertility. The vast majority of HCPs (n = 96; 86%) stated that fertility clinics have the responsibility to address unhealthy lifestyles prior to offering fertility treatment. Fertility nurses/midwives were significantly more likely than gynaecologists to state that fertility clinics have this responsibility (p = 0.040). Regarding practices, the patient's lifestyle was most commonly discussed by the gynaecologist (n = 107; 96%) during the first appointment (n = 105; 95%). The lifestyle factors that were being addressed, according to the vast majority of respondents, were smoking, weight, age, alcohol, and recreational drugs. Only three HCPs (from three different clinics) stated that their clinic offered a structured lifestyle modification programme. HCPs explained that they lacked the resources and expertise for offering a structured lifestyle modification programme. LIMITATIONS: Response rates were limited, but the responding Belgian gynaecologists and fertility nurses/midwives confirmed the findings of the previous study in Australian fertility nurses. CONCLUSIONS: HCPs working in Belgian fertility clinics value healthy lifestyle promotion but lack access to structured lifestyle modification programmes to implement in their daily clinical practice. Future studies should focus on developing and evaluating structured lifestyle modification programmes for patients with fertility problems.

Development and validity of a short web-based semi-quantitative Food Frequency Questionnaire applicable in both clinical and research setting: an evolution over time.

Background: Assessing dietary intake is valuable both in clinical practice and in research. In research and in clinical practice, long-term habitual dietary intake is most often of interest. Therefore, a web-based semi-quantitative Food Frequency Questionnaire (FFQ) was developed to measure habitual intake of nutrients and foods. Aim: This study aimed to assess content validity, convergent validity, and reliability of a 32-item semi-quantitative FFQ for adults. Methods: A total of three different cohorts of Flemish adults were recruited in the past 10 years. The first cross-sectional validation study took place in 2013, consequently in 2019 and 2021. Content validity was assessed in 2019 through a semi-structured cognitive interview. Convergent validity was assessed by examining mean differences, Wilcoxon signed-rank test, Spearman's correlation coefficients (SCC), and Bland-Altman analysis for energy, nutrient, and food group intake compared with a 3-day food record (FR). Additionally, consumers-only analysis was performed together with cross-classification analysis by assessing the ranking capabilities of the FFQ into quartiles and weighted kappa. Reliability was assessed through the evaluation of SCC and intra-class correlation (ICC) of test-retest assessment of the FFQ. Results: Spearman's correlation coefficient (SCC) for energy and absolute nutrient intake between the FFQ and the FR ranged from 0.02 to 0.54. Compared with absolute macronutrients, higher SCC was found for the majority of the relative macronutrient intake and most food groups. Bland-Altman plots showed improved agreement and decreasing bias between the FFQ and the FR over time. Misclassification of the FFQ for nutrients was acceptable and decreased over time (7.4, 7.5, and 6.8% in 2013, 2019, and 2021, respectively), but weighted kappa remained mostly fair (κ ≤ 0.20). The reliability of the FFQ was good and improved over time (mean SCC of 0.65 and 0.66 p <0.001 in 2013 and 2019). Conclusion: The short web-based FFQ is an easy, low-cost, and feasible tool with good reliability, low misclassification, and acceptable validity to compare nutrient densities and food group intake at the population level. The measurement of absolute intake remains debatable.

A blended preconception lifestyle programme for couples undergoing IVF: lessons learned from a multicentre randomized controlled trial.

STUDY QUESTION: What is the effect of a blended preconception lifestyle programme on reproductive and lifestyle outcomes of couples going through their first 12 months of IVF as compared to an attention control condition? SUMMARY ANSWER: This randomized controlled trial (RCT) was stopped prematurely because of the coronavirus disease 2019 (Covid-19) pandemic but the available data did not suggest that a blended preconception lifestyle programme could meaningfully affect time to ongoing pregnancy or other reproductive and lifestyle outcomes. WHAT IS KNOWN ALREADY: Increasing evidence shows associations between a healthy lifestyle and IVF success rates. Lifestyle programmes provided through a mobile phone application have yet to be evaluated by RCTs in couples undergoing IVF. STUDY DESIGN SIZE DURATION: A multicentre RCT (1:1) was carried out. The RCT started in January 2019 and was prematurely stopped because of the Covid-19 pandemic, leading to a reduced sample size (211 couples initiating IVF) and change in primary outcome (cumulative ongoing pregnancy to time to ongoing pregnancy). PARTICIPANTS/MATERIALS SETTING METHODS: Heterosexual couples initiating IVF in five fertility clinics were randomized between an attention control arm and an intervention arm for 12 months. The attention control arm received treatment information by mobile phone in addition to standard care. The intervention arm received the blended preconception lifestyle (PreLiFe)-programme in addition to standard care. The PreLiFe-programme included a mobile application, offering tailored advice and skills training on diet, physical activity and mindfulness, in combination with motivational interviewing over the telephone. The primary outcome was 'time to ongoing pregnancy'. Secondary reproductive outcomes included the Core Outcome Measures for Infertility Trials and IVF discontinuation. Changes in the following secondary lifestyle outcomes over 3 and 6 months were studied in both partners: diet quality, fruit intake, vegetable intake, total moderate to vigorous physical activity, sedentary behaviour, emotional distress, quality of life, BMI, and waist circumference. Finally, in the intervention arm, acceptability of the programme was evaluated and actual use of the mobile application part of the programme was tracked. Analysis was according to intention to treat. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 211 couples were randomized (105 control arm, 106 intervention arm). The hazard ratio of the intervention for time to ongoing pregnancy was 0.94 (95% CI 0.63 to 1.4). Little to no effect on other reproductive or lifestyle outcomes was identified. Although acceptability of the programme was good (6/10), considerable proportions of men (38%) and 9% of women did not actively use all the modules of the mobile application (diet, physical activity, or mindfulness). LIMITATIONS REASONS FOR CAUTION: The findings of this RCT should be considered exploratory, as the Covid-19 pandemic limited its power and the actual use of the mobile application was low. WIDER IMPLICATIONS OF THE FINDINGS: This is the first multicentre RCT evaluating the effect of a blended preconception lifestyle programme for women and their partners undergoing IVF on both reproductive and lifestyle outcomes. This exploratory RCT highlights the need for further studies into optimal intervention characteristics and actual use of preconception lifestyle programmes, as well as RCTs evaluating effectiveness. STUDY FUNDING/COMPETING INTERESTS: Supported by the Research foundation Flanders (Belgium) (FWO-TBM; reference: T005417N). No competing interests to declare. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT03790449. TRIAL REGISTRATION DATE: 31 December 2018. DATE OF FIRST PATIENT'S ENROLMENT: 2 January 2019.

Evaluation of a stand-alone mobile mindfulness app in people experiencing infertility: the protocol for an exploratory randomised controlled trial (MoMiFer-RCT).

INTRODUCTION: Infertility and its treatment bring a considerable emotional burden. Increasing evidence demonstrates the effectiveness of smartphone-delivered mindfulness apps for reducing symptoms of emotional distress in both clinical and non-clinical populations. Evidence on this topic in women, men and couples experiencing infertility is currently under-represented. The aim of the MoMiFer study is, therefore, to investigate the efficacy of a stand-alone mobile mindfulness app on symptoms of emotional distress and fertility-related quality of life in people experiencing infertility. METHODS AND ANALYSIS: This study is an exploratory randomised controlled trial (RCT) with open enrollment. The primary outcomes are symptoms of emotional distress and fertility-related quality of life. Secondary outcomes are mindfulness skills, repetitive negative thinking, self-compassion, user-rated quality of the stand-alone mobile mindfulness app and use of the app. Experience sampling method and standardised self-report questionnaires are combined within a repeated measures design to measure the effects of the stand-alone mobile mindfulness app on the primary and secondary outcomes, apart from the use of the app. The latter will be evaluated through app tracking. People, including women, men and couples, experiencing infertility (n=60) will be randomised to an intervention group receiving the stand-alone mobile mindfulness app for 3 months or a wait-list control group. The app follows the format and content of Mindfulness-Based Stress Reduction. Data will be collected at baseline, at 1.5 months and 3 months after randomisation. Analysis will be according to intention to treat and based on general linear modelling and multilevel mixed-effects modelling. ETHICS AND DISSEMINATION: This study received approval from the Medical Ethical Committee of the Leuven University Hospital (Belgium). The findings of this exploratory RCT will be disseminated through presentations at public lectures, scientific institutions and meetings, and through peer-reviewed scientific articles. TRIAL REGISTRATION NUMBER: NCT04143828.

Preconception lifestyle advice for people with infertility.

BACKGROUND: Infertility is a prevalent problem that has significant consequences for individuals, families, and the community. Modifiable lifestyle factors may affect the chance of people with infertility having a baby. However, no guideline is available about what preconception advice should be offered. It is important to determine what preconception advice should be given to people with infertility and to evaluate whether this advice helps them make positive behavioural changes to improve their lifestyle and their chances of conceiving. OBJECTIVES: To assess the safety and effectiveness of preconception lifestyle advice on fertility outcomes and lifestyle behavioural changes for people with infertility. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, PsycINFO, AMED, CINAHL, trial registers, Google Scholar, and Epistemonikos in January 2021; we checked references and contacted field experts to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs), randomised cross-over studies, and cluster-randomised studies that compared at least one form of preconception lifestyle advice with routine care or attention control for people with infertility. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. Primary effectiveness outcomes were live birth and ongoing pregnancy. Primary safety outcomes were adverse events and miscarriage. Secondary outcomes included reported behavioural changes in lifestyle, birth weight, gestational age, clinical pregnancy, time to pregnancy, quality of life, and male factor infertility outcomes. We assessed the overall quality of evidence using GRADE criteria. MAIN RESULTS: We included in the review seven RCTs involving 2130 participants. Only one RCT included male partners. Three studies compared preconception lifestyle advice on a combination of topics with routine care or attention control. Four studies compared preconception lifestyle advice on one topic (weight, alcohol intake, or smoking) with routine care for women with infertility and specific lifestyle characteristics. The evidence was of low to very low-quality. The main limitations of the included studies were serious risk of bias due to lack of blinding, serious imprecision, and poor reporting of outcome measures. Preconception lifestyle advice on a combination of topics versus routine care or attention control Preconception lifestyle advice on a combination of topics may result in little to no difference in the number of live births (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.79 to 1.10; 1 RCT, 626 participants), but the quality of evidence was low. No studies reported on adverse events or miscarriage. Due to very low-quality evidence, we are uncertain whether preconception lifestyle advice on a combination of topics affects lifestyle behavioural changes: body mass index (BMI) (mean difference (MD) -1.06 kg/m², 95% CI -2.33 to 0.21; 1 RCT, 180 participants), vegetable intake (MD 12.50 grams/d, 95% CI -8.43 to 33.43; 1 RCT, 264 participants), alcohol abstinence in men (RR 1.08, 95% CI 0.74 to 1.58; 1 RCT, 210 participants), or smoking cessation in men (RR 1.01, 95% CI 0.91 to 1.12; 1 RCT, 212 participants). Preconception lifestyle advice on a combination of topics may result in little to no difference in the number of women with adequate folic acid supplement use (RR 0.98, 95% CI 0.95 to 1.01; 2 RCTs, 850 participants; I² = 4%), alcohol abstinence (RR 1.07, 95% CI 0.99 to 1.17; 1 RCT, 607 participants), and smoking cessation (RR 1.01, 95% CI 0.98 to 1.04; 1 RCT, 606 participants), on low quality evidence. No studies reported on other behavioural changes. Preconception lifestyle advice on weight versus routine care Studies on preconception lifestyle advice on weight were identified only in women with infertility and obesity. Compared to routine care, we are uncertain whether preconception lifestyle advice on weight affects the number of live births (RR 0.94, 95% CI 0.62 to 1.43; 2 RCTs, 707 participants; I² = 68%; very low-quality evidence), adverse events including gestational diabetes (RR 0.78, 95% CI 0.48 to 1.26; 1 RCT, 317 participants; very low-quality evidence), hypertension (RR 1.07, 95% CI 0.66 to 1.75; 1 RCT, 317 participants; very low-quality evidence), or miscarriage (RR 1.50, 95% CI 0.95 to 2.37; 1 RCT, 577 participants; very low-quality evidence). Regarding lifestyle behavioural changes for women with infertility and obesity, preconception lifestyle advice on weight may slightly reduce BMI (MD -1.30 kg/m², 95% CI -1.58 to -1.02; 1 RCT, 574 participants; low-quality evidence). Due to very low-quality evidence, we are uncertain whether preconception lifestyle advice affects the percentage of weight loss, vegetable and fruit intake, alcohol abstinence, or physical activity. No studies reported on other behavioural changes. Preconception lifestyle advice on alcohol intake versus routine care Studies on preconception lifestyle advice on alcohol intake were identified only in at-risk drinking women with infertility. We are uncertain whether preconception lifestyle advice on alcohol intake affects the number of live births (RR 1.15, 95% CI 0.53 to 2.50; 1 RCT, 37 participants; very low-quality evidence) or miscarriages (RR 1.31, 95% CI 0.21 to 8.34; 1 RCT, 37 participants; very low-quality evidence). One study reported on behavioural changes for alcohol consumption but not as defined in the review methods. No studies reported on adverse events or other behavioural changes. Preconception lifestyle advice on smoking versus routine care Studies on preconception lifestyle advice on smoking were identified only in smoking women with infertility. No studies reported on live birth, ongoing pregnancy, adverse events, or miscarriage. One study reported on behavioural changes for smoking but not as defined in the review methods. AUTHORS' CONCLUSIONS: Low-quality evidence suggests that preconception lifestyle advice on a combination of topics may result in little to no difference in the number of live births. Evidence was insufficient to allow conclusions on the effects of preconception lifestyle advice on adverse events and miscarriage and on safety, as no studies were found that looked at these outcomes, or the studies were of very low quality. This review does not provide clear guidance for clinical practice in this area. However, it does highlight the need for high-quality RCTs to investigate preconception lifestyle advice on a combination of topics and to assess relevant effectiveness and safety outcomes in men and women with infertility.

A Mixed-Method Approach to Develop and Validate an Integrated Food Literacy Tool for Personalized Food Literacy Guidance.

BACKGROUND: Food literacy refers to all practicalities associated with healthy eating. Current food literacy tools are limited in practical use in clinical practice. Therefore, an integrated food literacy tool (IFLT) to assess food literacy and to personalize food literacy guidance was developed and validated. METHODS: Following an iterative process, a food literacy framework was developed and food literacy goals were defined. A corresponding food literacy screener (FLS) to assess food literacy was developed along with an algorithm to provide personalized food literacy guidance based on the food literacy assessment. Content validation of the FLS was assessed by a panel of experts, measuring item and scale content validity index (I/S-CVI) and by the target population in semi structured interviews with 15 adults of reproductive age. Subsequently, an online cross-sectional survey was conducted among 114 adults of reproductive age to evaluate the validity of the FLS. Construct validity was examined against both the validated healthy eating and weight self-efficacy scale and against a food frequency questionnaire assessing healthy eating self-efficacy (HESE) and diet quality, respectively. Reliability was assessed with a two-week test-retest. Pearson correlation tests were conducted. RESULTS: An IFLT consisting of a FLS and corresponding algorithm to personalize food literacy guidance by prioritizing food literacy goals was developed. The IFLT includes 24 food literacy goals, addressed by 17 FLS items. Every item received a weighting factor based on theory and expert opinion to prioritize food literacy goals according to personal needs. Content validity revealed that the FLS was rated relevant by experts (S-CVI = 0.93) and well-understood by the target population. The FLS has a good construct validity as it was positively correlated with diet quality (r = 0.536, p < 0.001) and with HESE (r = 0.685, p < 0.001). It also showed a good test-retest reliability (r = 0.721, p < 0.001). CONCLUSION: The newly developed IFLT is a practically applicable, context specific theory-and expert-based dual purpose tool to assess food literacy and to personalize food literacy guidance by prioritizing individuals' food literacy goals to their needs.

Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT).

INTRODUCTION: Infertility and in vitro fertilisation (IVF; with or without intracytoplasmic sperm injection) result in considerable emotional and financial burden. Increasing evidence suggests that lifestyle factors, including diet, physical activity and personal well-being, are associated with IVF-success rates. Currently, IVF is not routinely combined with a lifestyle programme. The preconception lifestyle (PreLiFe) randomised controlled trial (RCT) assesses the effects of a new mobile PreLiFe programme in couples undergoing IVF. METHODS AND ANALYSIS: A multicentre RCT including 460 heterosexual couples starting IVF in Belgian fertility clinics. IVF couples are randomised between an attention control group or the PreLiFe programme for a period of 12 months or until an ongoing pregnancy is confirmed by ultrasound. The attention control programme includes a mobile application with treatment information (ie, appointments and medication instructions) in addition to standard care. The PreLiFe programme includes a mobile application with the same treatment information in combination with a lifestyle programme. This new lifestyle programme includes tailored advice and skills training on diet, physical activity and mindfulness in combination with text messages and telephone interaction with a healthcare professional trained in motivational interviewing. The primary outcome of this RCT is the cumulative ongoing pregnancy rate within 12 months after randomisation. Secondary outcomes include changes in diet, physical activity, emotional distress, body mass index, waist circumference, quality of life and other reproductive outcomes including IVF discontinuation, clinical pregnancy rate and time to pregnancy. Additionally, partner support and the feasibility (use and acceptability) of the PreLiFe programme will be evaluated in the intervention group. Analysis will be according to intention to treat. ETHICS AND DISSEMINATION: This study has been approved by the Medical Ethical Committee of the Leuven University Hospital (Belgium) and the other recruiting clinics. The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT03790449; Pre-results.