Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01129505 |
| Other study ID # |
OPG-92367 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2009 |
| Est. completion date |
December 2013 |
Study information
| Verified date |
December 2023 |
| Source |
Western University, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Our longitudinal aim is to reduce childhood obesity using our two-pronged intervention
program, which includes healthy food choices and increased physical activity initiated during
pregnancy and re-instated in the early period after delivery for overweight and obese women.
We will accomplish this with our family-based Nutrition and Exercise Lifestyle Intervention
Program (NELIP) to promote healthy family living. An intervention targeting school-aged
children on the importance of healthy lifestyles occurs too late to prevent childhood obesity
and establish lifelong healthy body weights. To break this spiraling cycle of generations of
unhealthy body weights in Canadian children, and to reduce the risk of future obesity-related
health problems, it is necessary to prevent excessive pregnancy weight gain, high blood
sugars in the mother and to promote a healthy lifestyle during pregnancy and early post
delivery. With our NELIP team as a cornerstone, and our pilot data already collected with
promising results, we foresee an opportunity over the next 3 years to contribute to changing
patient care with emphasis on disease prevention and healthy family lifestyle initiation
early in life to reverse the trend of childhood obesity. With a solid research-based
initiative from the lab to the community by educating health care providers, future health
care can be improved by putting prevention-based programs into practice.
Healthy women = healthy babies = healthy families = healthy futures!!
Description:
Overweight and obesity have been identified as major neglected public health issues, as the
prevalence of unhealthy body weights is increasing world-wide at an alarming rate. There is a
robust link between the fetal environment and its long-term influence on health and
susceptibility to future chronic disease in the offspring. Obesity begets obesity, and an
unhealthy maternal metabolic state can have a profound influence on the risk of early obesity
development in the child. Excessive pregnancy weight gain and high pre-pregnant body-mass
index (BMI) have been linked to gestational diabetes (GDM) and macrosomic infants (birth
weight >4.0kg. Since much of the influence of the intrauterine milieu is transmitted to the
next generation non-genetically, potentially deleterious effects can be reversed and
prevented. An intervention targeting school-aged children on the importance of healthy
lifestyles occurs too late to prevent childhood obesity and establish lifelong healthy body
weights. To break the spiralling cycle of generations of unhealthy body weights in Canadian
children, and to reduce the risk of future obesity-related health problems, it is imperative
to prevent excessive pregnancy weight gain, GDM and to promote a healthy prenatal and early
postnatal lifestyle.
Reversing the obesity epidemic will involve a lifetime of effort by the medical and research
communities, however, over the next 3 years, we believe that we may contribute to the
solution by using a two-pronged approach by first targeting pregnant overweight and obese
women with a healthy lifestyle approach called the Nutrition & Exercise Lifestyle
Intervention Program (NELIP) combined with a Family-based Behavioural Treatment (FBBT) that
will prevent excessive weight gain and GDM, and promote a healthy fetal environment. The
second prong will use this healthy lifestyle (NELIP+FBBT) approach starting at 2 months
postpartum continuing to the first year, to minimize postpartum weight retention, encourage
breastfeeding, and promote a healthy family lifestyle.
Primary objectives are:
1. To prevent excessive pregnancy weight gain and GDM in order to decrease the incidence of
macrosomia and large for gestational age babies
2. To prevent weight retention postpartum and encourage healthy infant feeding practices in
order to decrease the risk of developing obesity during the first year of life.
Secondary objectives are:
1. To track pregnancy weight gain and postpartum weight loss, gradually reducing body
weight as needed (0.5 kg per week) to achieve and maintain a healthy body weight in the
mother
2. To track birth weight and infant growth within the first year of life (at 2, 6 and 12
months), including body weight, height, BMI, and body fatness, using the World Health
Organization growth charts as a standard.
Currently, the R. Samuel McLaughlin Foundation-Exercise and Pregnancy Lab at the University
of Western Ontario is the only research laboratory in North America actively investigating
metabolic changes in exercising pregnant and postpartum women. Our longitudinal aim is to
reduce obesity, and chronic disease risks (such as diabetes) in the offspring of overweight
and obese women using our two-pronged intervention program, which includes healthy food
choices and increased physical activity (NELIP and FBBT) initiated during pregnancy and
reinforced in the early postpartum period. With our NELIP team as a cornerstone, and our
pilot data already collected, we foresee an opportunity over the next 3 years to contribute
to intervention strategies and patient care with emphasis on disease prevention and healthy
family lifestyle initiation early in life to reverse the trend of childhood obesity. With a
solid research-based initiative from the lab to the community by knowledge translation to
health care providers, future health care costs can be reduced by putting prevention-based
programs into practice.
