Be Healthy in Pregnancy (B-HIP): A Trial to Study Nutrition and Exercise Approaches for Healthy P… (NCT01693510) | Clinical Trial Compass
CompletedNot Applicable
Be Healthy in Pregnancy (B-HIP): A Trial to Study Nutrition and Exercise Approaches for Healthy Pregnancy
Canada110 participantsStarted 2012-11-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy pregnant females \> 18 years of age with singleton pregnancies (either nulliparous or multiparous); less than 20 weeks gestation; pre-pregnancy BMI of \>25 and \< 40 kg/m2 (owing to the fact that severe obesity with BMI\> 40 may have limitations with respect to physical activity); plans to deliver at a Hamilton Health Sciences, St. Joseph's Healthcare Hamilton, Joseph Brant Hospital or by home birth but willing to attend research visits at the McMaster University Medical Centre site; approval of primary care provider; and able to provide signed informed consent.
Exclusion Criteria:
* Unable to understand some English; currently breastfeeding previous child; pregnancy resulting from in vitro fertilization; known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy; severe chronic gastrointestinal diseases or conditions; refusal to consume dairy foods due to intolerance or dislike; any significant heart, kidney, liver or pancreatic diseases; pre-existing diabetes; or a depression score above 13 on the validated Edinburgh Depression scale as that is indicative of severe depression and should be referred for treatment; currently smoking.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gestational weight gain within IOM guidelines
Timeframe: Change from baseline at 38 weeks gestation