None listed
Conditions
Brief summary
One third of New Zealand children are overweight or obese, with much higher rates among Pacific and Maori children (51% and 43%, respectively) who form about half the population in Counties Manukau district, South Auckland (our research area). In pregnant obese women (40% in Counties Manukau), unborn babies are exposed to excess nutrients inside the womb, making them more likely to be born large and become obese as children and adults. When obese women gain excessive weight during pregnancy (the majority) or develop gestational diabetes mellitus, problems for the baby are compounded. An important first step to breaking this vicious intergenerational cycle is to develop successful interventions for obese women starting in early pregnancy. If excessive pregnancy weight gain can be limited maternal and infant health may be improved. The proposed demonstration project will recruit obese women in early pregnancy and will test two novel, practical interventions: (1) a culturally appropriate, affordable, sustainable dietary education intervention; and (2) probiotic/placebo capsules. This demonstration project is an important first step to gaining insight into dietary interventions that may work in the South Auckland population, which has one of the highest rates of obesity in the world.
Interventions
This is a randomised controlled demonstration trial in 220 obese pregnant women to determine whether treatment with a probiotic capsule and/or dietary educational intervention:
1) Reduce excessive pregnancy weight gain
2) Reduce infant birthweight
Participants will be randomly allocated to one of the four study groups:
1) Probiotic and dietary intervention (group 1)
2) Placebo and dietary intervention (group 2)
3) Probiotic and routine dietary advice (group 3)
4) Placebo and routine dietary adv
This is a randomised controlled demonstration trial in 220 obese pregnant women to determine whether treatment with a probiotic capsule and/or dietary educational intervention: 1) Reduce excessive pregnancy weight gain 2) Reduce infant birthweight Participants will be randomly allocated to one of the four study groups: 1) Probiotic and dietary intervention (group 1) 2) Placebo and dietary intervention (group 2) 3) Probiotic and routine dietary advice (group 3) 4) Placebo and routine dietary advice (group 4, controls). Randomisation of participants to probiotics/placebo is double-blinded and the dietary intervention is unblinded. Probiotics: The oral probiotic capsules will contain Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 (Chr. Hansen A/S, Horsholm, Denmark) at a dose of 7*10x9 colony-forming units per day each. The probiotics capsules are taken once-daily from recruitment (between 12 weeks and zero days and 17 weeks and 6 days) until delivery. Compliance with probiotic/placebo will be assessed by counting and documenting capsule numbers remaining in canisters when repeat supplies are provided to participants at monthly intervals. Dietary intervention: Dietary education will be provided by a community health worker (CHW) trained in pregnancy nutrition, over four counselling sessions before the 26-28 week oral glucose tolerance test (OGTT). This will be complemented by 3-times weekly text messaging about healthy nutrition which will continue until birth. In-depth education will be provided by the CHW to women in the dietary intervention groups on healthy eating including: portion control, healthy food and drink choices, limiting energy dense foods, healthy recipes, label reading and managing cravings. Education on physical activity will cover four key physical activity messages (from the Te Wai o Rona program) which are relevant to pregnant women: look for ways to be active every day; increase daily exercise; move more, add more steps; and reduce sedentary leisure time. Each participant will have an initial 1 to 1.5 hour educational session (on average at about 14 weeks’ gestation) with the CHW. Three further 30 to 60 minute face-to-face sessions will occur with the CHW at two to three weekly intervals and be completed before the 26-28 week OGTT. Compliance with the dietary intervention will be assessed by the number of educational sessions participants attend with the CHW.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
1) Women with a BMI greater than or equal to 30 kg/m2, 2) singleton pregnancy 3) between 12 weeks 0 days and 17 weeks and 6 days of gestation 4) able to provide informed written consent
Exclusion criteria
1) pre-existing diabetes or HbA1c at booking >=50 mmol/mol 2) taking probiotic supplements 3) known congenital abnormality 4) medications or medical conditions which alter glucose metabolism 5) bariatric surgery 6) severe hyperemesis
Outcome results
None listed