National Institute for Health Research, Guys and St Thomas' Charity, Chief Scientist Office Scotland, Tommy's Charity.

BackgroundHealth literacy (HL) is an important public health issue. Current measures have drawbacks in length and/or acceptability. The US-developed Newest Vital Sign (NVS) health literacy instrument measures both reading comprehension and numeracy skills using a nutrition label, takes 3 minutes to administer, and has proven to be acceptable to research subjects. This study aimed to amend and validate it for the UK population.MethodsWe used a three-stage process; (1) a Delphi study with academic and clinical experts to amend the NVS label to reflect UK nutrition labeling (2) community-based cognitive testing to assess and improve ease of understanding and acceptability of the test (3) validation of the NVS-UK against an accepted standard test of health literacy, the Test of Functional Health Literacy in Adults (TOFHLA) (Pearson’s r and the area under the Receiver Operating Characteristic (ROC) curve) and participant educational level. A sample size calculation indicated that 250 participants would be required. Inclusion criteria were age 18–75 years and ability to converse in English. We excluded people working in the health field and those with impaired vision or inability to undertake the interview due to cognitive impairment or inability to converse in English.ResultsIn the Delphi study, 28 experts reached consensus (3 cycles). Cognitive testing (80 participants) yielded an instrument that needed no further refinement. Validation testing (337 participants) showed high internal consistency (Cronbach’s Alpha = 0.74). Validation against the TOFHLA demonstrated a Pearson’s r of 0.49 and an area under the ROC curve of 0.81.ConclusionsThe NVS-UK is a valid measure of HL. Its acceptability and ease of application makes it an ideal tool for use in the UK. It has potential uses in public health research including epidemiological surveys and randomized controlled trials, and in enabling practitioners to tailor care to patient need.

BackgroundComplex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity.MethodsWe undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2).Diet was assessed by repeated triple pass 24-hour dietary recall and physical activity by accelerometry and questionnaire, at 16+0 to 18+6 and at 27+0 to 28+6 weeks’ gestation in women in control and intervention arms. Attitudes to behaviour change and quality of life were assessed and a process evaluation undertaken. The full RCT protocol was undertaken to assess feasibility.ResultsCompared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI −47 to −20), (p < 0.001) and saturated fat intake (−1.6% energy, 95% CI −2.8 to −0. 3) at 28 weeks’ gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks’ gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery.ConclusionsThis pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT.Trial registrationTrial Registration Number: ISRCTN89971375

This study finds that there is a deficiency of appropriately designed interventions for maternal obesity and it concludes by highlighting areas for developing a more effective strategy.