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

Primary Purpose

Excessive Weight Gain in Pregnancy as Antepartum Condition, Obesity, Weight Gain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise and Nutrition Intervention
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Excessive Weight Gain in Pregnancy as Antepartum Condition focused on measuring Excess gestational weight gain (GWG), Obesity, Type 2 diabetes, Elevated fats in the blood, High blood pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • McMaster University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise and Nutrition Intervention

Usual Prenatal Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Gestational weight gain within IOM guidelines
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?

Secondary Outcome Measures

Bone outcomes
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).

Full Information

First Posted
September 20, 2012
Last Updated
September 30, 2020
Sponsor
McMaster University
Collaborators
Dairy Farmers of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01693510
Brief Title
Be Healthy in Pregnancy (B-HIP): A Trial to Study Nutrition and Exercise Approaches for Healthy Pregnancy
Acronym
BHIP
Official Title
Be Healthy in Pregnancy (B-HIP): A Randomized Clinical Trial (RCT) to Study Nutrition and Exercise Approaches for Healthy Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 12, 2012 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Dairy Farmers of Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Weight Gain in Pregnancy as Antepartum Condition, Obesity, Weight Gain, Type 2 Diabetes
Keywords
Excess gestational weight gain (GWG), Obesity, Type 2 diabetes, Elevated fats in the blood, High blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Nutrition Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Prenatal Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise and Nutrition Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational weight gain within IOM guidelines
Description
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?
Time Frame
Change from baseline at 38 weeks gestation
Secondary Outcome Measure Information:
Title
Bone outcomes
Description
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).
Time Frame
6 months post-partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie A. Atkinson, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35623838
Citation
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.
Results Reference
derived
PubMed Identifier
31732740
Citation
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.
Results Reference
derived

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

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