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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by McMaster University
Sponsor:
Collaborator:
Dairy Farmers of Canada
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01693510
First received: September 20, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Excessive Weight Gain in Pregnancy as Antepartum Condition
Obesity
Weight Gain
Type 2 Diabetes
Behavioral: Exercise and Nutrition Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Be Healthy in Pregnancy (B-HIP): A Randomized Clinical Trial (RCT) to Study Nutrition and Exercise Approaches for Healthy Pregnancy

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Gestational weight gain within IOM guidelines [ Time Frame: Change from baseline at 38 weeks gestation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months post-partum ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 110
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: In most previous studies and published guidance the focus has been on aerobic exercise. Walking is the easiest physical activity to undertake and also to implement in terms of setting goals of steps and monitoring of adherence using accelerometer-type devices as demonstrated in our previous studies. Walking was demonstrated most practical since women reduced moderate and vigorous physical activity during pregnancy but levels of walking were maintained.
Behavioral: Exercise and Nutrition Intervention
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 10 on the validated Edinburgh Depression scale as that is indicative of severe depression and should be referred for treatment; currently smoking.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693510

Contacts
Contact: Stephanie A. Atkinson, PhD 905-521-2100 ext 75644 satkins@mcmaster.ca
Contact: Elizabeth Fonseca 905-521-2100 ext 75644 fonseca@mcmaster.ca

Locations
Canada, Ontario
McMaster University Medical Centre Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Stephanie Atkinson, PhD    905-521-2100 ext 75644      
Principal Investigator: Stephanie A. Atkinson, PhD         
Sponsors and Collaborators
McMaster University
Dairy Farmers of Canada
Investigators
Principal Investigator: Stephanie A. Atkinson, PhD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01693510     History of Changes
Other Study ID Numbers: BHIP-DFC
Study First Received: September 20, 2012
Last Updated: March 13, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Excess gestational weight gain (GWG)
Obesity
Type 2 diabetes
Elevated fats in the blood
High blood pressure

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 24, 2014