Effectiveness and Cost-Effectiveness of a Cluster-Randomized Prenatal Lifestyle Counseling Trial: A Seven-Year Follow-Up

Abstract

There is a link between the pregnancy and its long-term influence on health and susceptibility to future chronic disease both in mother and offspring. The objective was to determine whether individual counseling on physical activity and diet and weight gain at five antenatal visits can prevent type 2 diabetes mellitus (T2DM) and overweight or improve glycemic parameters, among all at-risk-mothers and their children. Another objective was to evaluate whether gestational lifestyle intervention was cost-effective as measured with mother’s sickness absence and quality-adjusted life years (QALY). This study was a seven-year follow-up study for women, who were enrolled to the antenatal cluster-randomized controlled trial (RCT). Analysis of the outcome included all women whose outcome was available, in addition with subgroup analysis including women adherent to all lifestyle aims. A total of 173 women with their children participated to the study, representing 43% (173/399) of the women who finished the original RCT. Main outcome measures were: T2DM based on medication use or fasting blood glucose or oral glucose tolerance test (OGTT), body mass index (BMI), glycosylated hemoglobin (HbA1c). None of the women were diagnosed to have T2DM. HbA1c or fasting blood glucose differences were not found among mothers or children. Differences in BMI were non-significant among mothers (Intervention 27.3, Usual care 28.1 kg/m2, p = 0.33) and children (I 21.3 vs U 22.5 kg/m2, p = 0.07). Children’s BMI was significantly lower among adherent group (I 20.5 vs U 22.5, p = 0.04). The mean total cost per person was 30.6% lower in the intervention group than in the usual care group (I €2,944 vs. U €4,243; p = 0.74). Intervention was cost-effective in terms of sickness absence but not in QALY gained i.e. if society is willing to pay additional €100 per one avoided sickness absence day; there is a 90% probability of the intervention arm to be cost-effective. Long-term effectiveness of antenatal lifestyle counseling was not shown, in spite of possible effect on children’s BMI. Cost-effectiveness of the intervention in terms of sickness absence may have larger societal impact.

Can antenatal diet and lifestyle interventions influence childhood obesity? A systematic review

“…The number of offspring investigated from the antenatal studies ranged from 72 to 698. Offspring age at follow‐up was 6 months (Horan et al, ; Patel et al, ), 1 year (Rauh, Gunther, Kunath, Stecher, & Hauner, ; Vesco et al, ), 2.8 years (Tanvig et al, ), 5 years (Ronnberg, Hanson, & Nilsson, ), and 7 years (Kolu et al, ). The measures of adiposity recorded are described in Table and included anthropometric measurements of weight, height, BMI, circumferences (mid‐upper arm, abdominal, hip, thigh), skinfold thicknesses, and estimated total body composition values via dual‐energy X‐ray absorptiometry (DXA) scans.…”

“…When reported, anthropometric measures were converted to z‐scores and adjusted for infant sex, age, and length and standard deviations using WHO growth standards (Horan et al, ; Mustila, Raitanen, Keskinen, Saari, & Luoto, ; Patel et al, ; Ronnberg et al, ; Tanvig et al, ; Vesco et al, ). Kolu et al () calculated the children's BMI using a Finnish BMI for age calculator for children aged 2–20 years (Saari et al, ). Sums and ratios of anthropometric characteristics as opposed to individual measures were also used to estimate infant adiposity (Horan et al, ; Patel et al, ; Vesco et al, ).…”

“…However, when the data were analysed as a cohort using multiple linear regression modelling, associations between specific maternal dietary variables and infant adiposity, glycaemic index, saturated fat, and sodium intake in pregnancy were associated with some measures of offspring adiposity at follow‐up including weight‐for‐age z‐score, BMI‐for‐age z‐score, and select skinfold measurements. Kolu et al () conducted a separate statistical analysis of a subset that included data obtained from children of women adherent to the lifestyle intervention in the NELLI trial, which included women from all BMI categories. When this subset was analysed, summarised in Table , there was a significant reduction in childhood BMI between the intervention and control groups at 7 years of age ( n = 24, I: 20.5 kg/m 2 vs. C: 22.5 kg/m 2 , p = .04).…”

“…The overall quality of the included offspring follow‐up studies varied and is summarised in Table ; two studies were classified as moderate risk (Kolu et al, ; Vesco et al, ), one as high (Mustila et al, ), and the remaining five studies as low risk (Horan et al, ; Patel et al, ; Rauh et al, ; Ronnberg et al, ; Tanvig et al, ). The main source of bias across all studies was the high rate of participant attrition to offspring follow‐up.…”

“…There is no ideal measurement of infant or childhood adiposity, and a balance between costs, efficiency, age of the child, and ease of collection influences the type of data collected. BMI z‐scores or BMI were analysed by five studies and adjusted for infant age and gender and reported as standard deviations (SD) from the median (Horan et al, ; Kolu et al, ; Patel et al, ; Ronnberg et al, ; Tanvig et al, ). However, BMI is an inaccurate estimate of body fat mass in children, and the same thresholds do not apply as in the adult population.…”