Timmermans 2019.
Study name | TOP‐mums |
Methods |
Study design: parallel‐group randomised controlled trial Setting: region (South of Limburg, The Netherlands) |
Participants | 112 overweight or obese women planning to conceive within 1 year |
Interventions |
Control: routine care Access to the general practitioner and child wish consultations by a midwife. In addition, ART as part of care as usual for subfertile women according to the Dutch infertility guidelines Intervention: combination Multi‐disciplinary lifestyle intervention from preconception to 1 year postpartum. Lifestyle programme based on lifestyle habits measured with nutritional diary and activity tracker and developed by medical background lifestyle coach trained in motivational interviewing + mHealth Coaching "Smarter Pregnancy" = digital tailored coaching on nutrition and lifestyle, 3 digital posts/week, advice, seasonal recipes, and additional questions addressing lifestyle behaviour during pregnancy (26 weeks) + psychological guidance on eating behaviour if necessary (2 to 3 times a week for 4 months) + personal dietary guidance by dietician every 1 or 2 months + physical activity programme (with physiotherapist) |
Outcomes | Live birth or ongoing pregnancy; any adverse event (perinatal complications of mother and child); miscarriage; reported behavioural changes in weight (difference in weight in kg from baseline to 6 weeks postpartum = primary outcome), smoking (smoking cessation and biochemical verification of tobacco use), diet (dietary habits), and physical activity (physical activity habits); birth weight; gestational age; time to pregnancy; quality of life |
Starting date | July 2016 |
Contact information | a.vreugdenhil@mumc.nl |
Notes |
Status of study: ongoing: study author replied by email on 26 May 2020 that trial was still ongoing, and that no data are available that can be included in the review at this point. Estimated study completion date on Clinicaltrials.gov is December 2021 Other notes: inclusion of fertile couples and couples with infertility. Intervention from preconception to 1 year postpartum |
6MWT: 6‐Minute Walk test.
ART: assisted reproductive technology.
BMI: body mass index.
FertiQOL: Fertility Quality of Life tool.
FFQ: Food Frequency Questionnaire.
ICSI: intracytoplasmic sperm injection.
IPAQ: International Physical Activity Questionnaire.
IVF: in vitro fertilisation.
MEDAS: XXX.