- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693510
Be Healthy in Pregnancy (B-HIP): A Trial to Study Nutrition and Exercise Approaches for Healthy Pregnancy (BHIP)
Be Healthy in Pregnancy (B-HIP): A Randomized Clinical Trial (RCT) to Study Nutrition and Exercise Approaches for Healthy Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- McMaster University Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Exercise and Nutrition Intervention
Nutrition intervention: The proposed nutrition plan is a high protein (25% energy) diet providing low fat dairy foods and individualized to energy needs.
Dairy foods are accepted by women during pregnancy as a healthy choice (from pilot study) and in our recent birth cohort study, women consumed an average of 3 or more servings of dairy per day.
Exercise intervention: Most previous studies and published guidance focus on aerobic exercise such as walking as it is the easiest physical activity to implement in pregnancy in terms of setting goals of steps and monitoring of adherence using accelerometer-type devices.
Walking is also the most practical since women reduced moderate and vigorous physical activity during pregnancy but levels of walking were maintained.
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Both Intervention and Control participants and their care providers receive the new Health Canada guide on Healthy Weight Gain During Pregnancy.
For the Experimental Group, the exercise intervention includes a custom-designed pregnancy-specific group walking class of 30-60 min.
1x/week and a prescribed at-home walking program to reach 10,000 steps/day.
The nutrition intervention is a high protein (25% energy) low-fat dairy food plan designed to meet energy needs and with individualized counselling.
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NO_INTERVENTION: Usual Prenatal Care
Mothers in the Control Group will be followed by their primary care provider and have usual access to public health.
In addition, women will have the opportunity to attend one focus group session exploring women's experiences with nutrition, exercise, and weight gain in pregnancy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gestational weight gain within IOM guidelines
Time Frame: Change from baseline at 38 weeks gestation
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Among pregnant women (population), 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 GWG within the IOM guidelines (outcome) over the pregnancy period?
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Change from baseline at 38 weeks gestation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone outcomes
Time Frame: 6 months post-partum
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Bone status in mothers and infants at 6 months after delivery will be assessed against reference data for bone mineral content (infants) or bone mineral density (mothers) and anthropomorphic outcomes in babies (weight and height).
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6 months post-partum
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie A. Atkinson, PhD, McMaster University
Publications and helpful links
General Publications
- Maran A, Atkinson SA, Bertram V, Vanniyasingam T, Thabane L, Mottola MF, Phillips SM; BHIP study team. Exploring comparative assessment of adiposity measures during pregnancy and postpartum. Clin Nutr ESPEN. 2022 Jun;49:365-371. doi: 10.1016/j.clnesp.2022.03.021. Epub 2022 Mar 23.
- Perreault M, Atkinson SA, Meyre D, Fusch G, Mottola MF; BHIP Study Team. Summer Season and Recommended Vitamin D Intake Support Adequate Vitamin D Status throughout Pregnancy in Healthy Canadian Women and Their Newborns. J Nutr. 2020 Apr 1;150(4):739-746. doi: 10.1093/jn/nxz276.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHIP-DFC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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