Clinical trial NCT01129505: Preventing Childhood Obesity: A Two-pronged Approach Starting in Pregnancy and the First Year Postpartum
Official title: Preventing Childhood Obesity: Early Intervention During Pregnancy and First Year Postpartum for Overweight and Obese Women Using a Two-pronged Family-based Nutrition & Exercise Lifestyle Intervention Program (NELIP).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Excessive Weight Gain in Pregnancy With Baby Delivered
Dietary Modification
Healthy Lifestyle Habits
Keywords: pregnancy
intervention
exercise
nutrition
infants
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Health Research Foundation
First posted: 2010-05-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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!!

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* medically pre-screened for contraindications to exercise
* prior to 16 weeks gestation (pregnancy program)
* singleton pregnancy and pre-pregnancy BMI equal or greater than 25
* before 2 months post delivery (postpartum program)
* BMI equal or greater than 25 (postpartum program)

Exclusion Criteria:

* diagnosed with gestational diabetes or type 2 diabetes

Primary outcomes:
measure: To prevent excessive pregnancy weight gain and GDM to decrease incidence of macrosomia
timeFrame: weekly weight gain during pregnancy and birth
Secondary outcomes:
measure: To prevent weight retention in the mother and encourage healthy infant feeding practices
timeFrame: 2, 6 and 12 months post delivery
Other outcomes:
Locations:
city: London
country: Canada
facility: Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Michelle F Mottola, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mottola MF, Giroux I, Gratton R, Hammond JA, Hanley A, Harris S, McManus R, Davenport MH, Sopper MM. Nutrition and exercise prevent excess weight gain in overweight pregnant women. Med Sci Sports Exerc. 2010 Feb;42(2):265-72. doi: 10.1249/MSS.0b013e3181b5419a.