Be Healthy in Pregnancy (B-HIP): A Trial to Study Nutrition and Exercise Approaches for Healthy Pregnancy — BHIP  

Obesity Clinical Trial

Official title: Be Healthy in Pregnancy (B-HIP): A Randomized Clinical Trial (RCT) to Study Nutrition and Exercise Approaches for Healthy Pregnancy

Status Completed

Clinical Trial Summary

Weight gained during pregnancy is referred to as gestational weight gain (GWG). Excess GWG is a widespread problem that occurs in 55-75% of Canadian women who enter pregnancy overweight or obese (a group that represents over 50 % of all pregnant women) and about 40% women of normal weight. Excess GWG is associated with complications of pregnancy, such as post-partum weight retention, type 2 diabetes, elevated fats in the blood, and high blood pressure and may also lead to problems with the health of the newborn child. Our research aims to find ways to control GWG by developing new and practical approaches to diet and exercise targeted to overweight pregnant women that hold promise of improving their health both during pregnancy and thereafter. The experimental intervention is a diet of higher protein provided by dairy foods combined with an exercise program modified to the abilities of overweight pregnant women; and the control is the usual advice given by their primary care providers, information on healthy pregnancy from Health Canada, and a focus group session exploring women's experiences with exercise, nutrition, and gestational weight gain. The results of this study will allow us to design future large clinical studies in all pregnant women to help control the weight gain in all pregnant women.

Clinical Trial Description

This will be a 2-arm randomized 1-site trial. Recruitment will be within the community care clinics by poster and flyer advertisements.

Primary research question: Among pregnant women, does introducing a structured and monitored nutrition and exercise program (treatment) in early pregnancy compared with Usual Prenatal Care (control) increase the likelihood of attaining gestational weight gain within the Institute of Medicine (IOM) guidelines over the pregnancy period?

Experimental and Control groups: Both groups of mothers and their health care providers will be given the Health Canada materials on "Healthy Weight Gain during Pregnancy", "Eating Well with Canada's Food Guide" and the "Pregnancy Weight Gain Calculator". Baseline information will be recorded for eligible and consenting women after which they will be randomized to Experimental or Control group. Nutrition intake, physical measures and physical activity will be recorded at baseline, 26-28 weeks and 36-38 weeks of gestation and 6 months post partum in the same manner for both groups. All mothers will receive the study promotional materials and small incentives. Also, all mothers will be followed by their primary care provider and have usual access to Public Health. ;

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus, Type 2
• Excessive Weight Gain in Pregnancy as Antepartum Condition
• Obesity
• Type 2 Diabetes
• Weight Gain

• NCT number: NCT01693510
• Study type: Interventional
• Source: McMaster University
• Status: Completed
• Phase: N/A
• Start date: November 12, 2012
• Completion date: April 30, 2019