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Table. 1 Domains and assessment questionnaires for secondary analyses in the Bump2Baby and Me Study

From: Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children

Domain Measurement/questionnaire Details Time point measured References
Maternal
Diet Food4Me Food Frequency Questionnaire (FFQ) Contains questions on the average consumption of 157 food items over the previous month. Food portion size is estimated using photographs. The questionnaire has been validated against standard food frequency questionnaires and 4-day weighed food diaries, in multiple countries including Ireland, Spain, and the UK.
Measurements units:
Continuous: nutrient values
Categorical: meeting dietary guidelines
Analysis:
Compare mean/median and SD/IQR and meeting guidelines (yes/no)
- Pregnancy (12–24 weeks’ gestation)
- Postpartum (12 months)a
[31]
 Physical activity 1. Pregnancy Physical Activity Questionnaire (PPQA)
2. Smartphone app inbuilt activity tracker (intervention group only)
1. The PPQA was identified as the most psychometrically sound self-reported measure of physical activity in pregnancy. It is available in English and Spanish.
2. The smartphone inbuilt activity tracking capabilities of individuals phones will be used to record physical activity for the intervention group. This will be used to record the estimated step count for participants.
Measurement units:
Continuous: metabolic equivalent minutes (METs), Time spent in moderate/vigorous physical activity, steps per day.
Categorical: Meeting physical activity recommendations
Analysis:
Compare mean/median and SD/IQR and meeting guidelines (yes/no)
- Pregnancy (12–24 weeks’ gestation)
- Postpartum (12 months)a
[32, 33]
Breastfeeding 1. Iowa Infant Feeding Attitudes Scale (IIFAS)
2. Adapted version of the Australian National Infant Feeding Survey 2010 and InFANT Extend Study
1. The IIFAS has been validated in English and Spanish, with good reliability.
2. Adapted questions will be used from the Australian National Infant Feeding Survey and InFANT Extend Study to assess levels of breastfeeding, feeding styles (including combinations of breast milk and formula), experience of pumping, timing and frequency of feeding, and age of weaning.
Measurement units:
Continuous: IIFA score (17–85)
Categorical: IIFAS scores will be categorised into groups: (1) positive to breastfeeding, (2) neutral, and (3) positive to formula feeding. Groups will be created based on previous breastfeeding experience, breastfeeding intentions, and meeting breastfeeding and infant feeding recommendations.
Analysis:
Compare the mean/median and SD/IQR and categories
- Pregnancy (12–24 weeks’ gestation)
- Postpartum (3, 6, 9, 12a months)
[34,35,36,37]
Health status EuroQol-5 Dimension (EQ 5-D-L) The EQ 5-D-L is a standardised instrument for measuring generic health status and has been extensively validated in over 200 countries.
Measurement units:
Continuous: self-rated EQ visual analogue scale (1–100), score 1–5 for five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (score 1–5)
Categorical: high/low across the five dimensions
Analysis:
Compare scores in categories, mean/median, and SD/IQR for visual analogue scale
- Pregnancy (12–24 weeks’ gestation)
- Postpartum (12 months)a
[38, 39]
Psychological health Edinburgh Postnatal Depression Scale (EPDS) The EDPS is a questionnaire originally developed to assist in identifying possible symptoms of depression in the postpartum period. It also has adequate sensitivity and specificity to identify depressive symptoms in the antenatal period and is useful in identifying symptoms of anxiety. The EDPS has been extensively validated in multiple languages including Spanish, with good sensitivity, reliability and established validity against diagnostic interviews.
Measurement units:
Continuous: score (1–25)
Categories: at-risk of depression (< 13, yes/no)
Analysis:
Compare the mean/median and SD/IQR and categories
- Pregnancy (12–24 weeks’ gestation)
- Postpartum (3, 6, 9, 12a months)
[40,41,42]
Sleep quality Pittsburgh Sleep Quality Index (PSQI) The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The PSQI is one of the most widely used sleep questionnaires and has been translated and validated into multiple languages, including Spanish, and amongst antenatal and postpartum populations.
Measurement units:
Continuous: total score (0–21), 7 subscores (0–3)
Categories: poor sleep quality (> 5, yes/no)
Analysis:
Compare the mean/median and SD/IQR and categories
- Pregnancy (12–24 weeks’ gestation)
- Postpartum (3, 6, 9, 12a months)
[43,44,45]
Health literacy Health Literacy Questionnaire (HLQ) and electronic Health Literacy Questionnaire (eHLQ) The HLQ and eHLQ are a series of independent scales that assess functional health literacy and the fuller constructs of health literacy. The HLQ has extensive cross-cultural validity and has translations available in Spanish. The eHLQ is well-defined, validated, and reliable and was designed to evaluate interactions with digital health services.
Measurement units:
Continuous: 9 subscales scores (1–5)
Categories: adequate/inadequate health literacy
Analysis:
Compare the mean/median and SD/IQR and categories
- Pregnancy (12–24 weeks’ gestation)
- Postpartum (12 months)a
[46, 47]
Willpower 6 Implicit Theories of Willpower – Resisting Temptation (ITW-RT) The ITW-RT scale has been shown to have good psychometric properties, including predictive and concurrent validity.
Measurement units:
Continuous: total score (1–30)
Categories: non-limited theory of willpower (score 0–17), limited theory of willpower (18–30)
Analysis:
Compare the mean/median and SD/IQR and categories
- Pregnancy (12–24 weeks’ gestation)
- Postpartum (12 months)a
[48,49,50]
Infant
Development Ages & Stages Questionnaires, Third Edition (ASQ-3) The ASQ-3 is a parental-reported developmental screening tool that shows high reliability, internal consistency, sensitivity, and specificity. It is available in English and Spanish.
Measurement units:
Continuous: 5 subscale scores (5 areas; communication, gross motor, fine motor, problem solving, personal-social)
Categories: typical development or need for monitoring/further assessment
Analysis:
Compare the mean/median and SD/IQR scores of sub scales and categories
- Postpartum (12 months) [51, 52]
Physical activity Two question items—sedentary/screen time and outdoor play Infant physical activity at 12 months of age will be assessed using two question items: one on sedentary time including screen time over a typical week and time spent in situations that restrict movement (e.g. stroller, playpen) and one on the amount of activity about the number of hours the child typically spends playing outdoors on weekdays and weekend days.
Measurement units:
Continuous: time spent sedentary or playing (minutes)
Categories: meeting guidelines
Analysis:
Compare the mean/median and SD/IQR and meeting guidelines (yes/no)
- Postpartum (12 months)  
Diet Complementary Food Frequency Questionnaire (CFFQ) The CFFQ comprises 49 food items under six food categories which measures what the infant consumed over the last 4 days. Breastmilk and formula intakes are also measured in this validated tool.
Measurement units:
Continuous: nutrient values
Categories: meeting dietary guidelines
Analysis:
Compare the mean/median and SD/IQR and meeting guidelines (yes/no)
- Postpartum (12 months) [53]
Health status Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) Incidence of infections, eczema, and atopic dermatitis will be assessed using the PO-SCORAD, a self-assessment tool for use by parents which has been validated in 12 European countries.
Measurement units:
Continuous: PO-SCORAD Score (0–90)
Categories: incidence of infections, eczema, and atopic dermatitis (yes/no)
Analysis:
Compare the mean/median and SD/IQR and incidences
- Postpartum (12 months) [54]
Health costs Adapted questionnaires from the InFANT Extend Study and the Infant Feeding Practices Study II Participant employment, childcare, and out of pocket costs will be estimated by self-completed questionnaires derived from the Infant Feeding Practices Study II. Health costs for the child will be assessed using an adaption of the instrument used to assess costs in the InFANT Extend Study. The questionnaire covers health costs, travel costs, and lost productivity during the antenatal and postpartum periods.
Measurement units:
Continuous: productivity loss (absenteeism and presenteeism), out-of-pocket costs
Categorical: employment status, childcare status, high/average/low costs, and productivity losses
Analysis:
Compare the mean/median and SD/IQR and groups
- Postpartum (3, 6, 9, 12a months) [37, 55]
Sleep Brief Infant Sleep Questionnaire (BISQ) Sleep duration, night wakings, and method of falling asleep will be measured using the BISQ which is available in English and Spanish.
Measurement units:
Continuous: time spent asleep/awake (minutes) and sleep behaviour scores
Categorical: problem sleeper (yes/no), meeting sleep recommendations (yes/no)
Analysis:
Compare the mean/median and SD/IQR and groups
- Postpartum (3, 6, 9, 12a months) [56]
  1. For measurements collected at more than one time point
  2. aThe primary outcome of interest