Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by McMaster University
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Agriculture and Agri-Food Canada
Dairy Farmers of Canada
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01689961
First received: September 13, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

Excess weight gain in pregnancy is a major problem affecting 55-75% of Canadian women who enter pregnancy overweight or obese and about 40% of women who are normal weight. Excess weight gain puts mothers at risk for health problems such as diabetes and developing or sustaining obesity after pregnancy, and puts their babies at risk of being born too large or developing related health problems. Mothers will be randomized to a structured high dairy protein diet and walking program or the usual care by their care provider. The investigators research questions are: Will a structured nutrition and exercise program in pregnancy compared to usual prenatal care increase the chance that mothers will achieve pregnancy weight gain within the current recommendations; improve health measures, in mother and infant at six months post-partum; to evaluate the benefits of a high dairy intake in pregnancy on maintenance of bone status in the mother and bone health outcomes in the child in early life (6 months); and to investigate the interactions between genes associated with bone health and high dairy diet supplementation on bone status in mothers during pregnancy, and bone health in mothers post-delivery and children to 6 months of age. Mothers' weight, physical activity and adherence to the nutrition plan will be assessed until birth and at follow-up with their infants at 6 months after birth. The research team will ensure new information is quickly transferred to programs to assist women to have healthier pregnancies.


Condition Intervention
Pregnancy Complications
Weight Gain
Behavioral: Structured + monitored nutrition and exercise intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise

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 gestational weight gain within the IOM guidelines (outcome) over the pregnancy period?


Secondary Outcome Measures:
  • Maternal and infant outcomes [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    The secondary research question is whether the proposed intervention will result in i) better maternal outcomes (outcome) at 6 months post- partum; and ii) better infant outcomes (outcome) at 6 months post partum?

  • Bone health of mother and baby [ Time Frame: 6 months post-partum ] [ Designated as safety issue: No ]

    In mother: plasma/serum measures of bone mineralization and bone resorption and vitamin D status; bone mineral density as measured by dual energy x-ray absorptiometry scan.

    In infant: bone mineral content as measured by dual energy x-ray absorptiometry scan.



Estimated Enrollment: 350
Study Start Date: November 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutrition+Exercise Intervention

Structured + monitored nutrition and exercise intervention:

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 for 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. The intervention will include 2 x/month weight monitoring and records of nutrition and activity to ensure adherence

Behavioral: Structured + monitored nutrition and exercise intervention
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 for 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. The intervention will include 2 x/month weight monitoring and records of nutrition and activity to ensure adherence.
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 services. In addition, they will be asked to attend 2 focus group sessions exploring women's experiences with exercise, nutrition, and weight gain in pregnancy. Women will receive information about healthy pregnancy from Health Canada.

Detailed Description:

This will be a 2-arm randomized 3-site trial. Recruitment will be within the community care clinics by poster and flyer advertisements. Pregnant women will be stratified by BMI categories and study site and randomized within strata to Group A (Nutrition+Exercise intervention program) or Group B (Usual Prenatal Care + Health Canada materials about healthy pregnancy + two focus group sessions exploring women's experiences with exercise, nutrition and weight gain in pregnancy).

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? Secondary research questions: Among pregnant women (population), does introducing a structured and monitored nutrition and exercise program in early pregnancy (intervention) compared with Standard Prenatal Care (control) lead to 1) better maternal outcomes (outcome) at 6 months post- partum; and ii) better infant outcomes (outcome) at 6 months post partum?; and 2) i) to evaluate the benefits of a high dairy intake in pregnancy on maintenance of bone status in the mother and bone health outcomes in the child in early life (6 months); and ii) to investigate the interactions between genes associated with bone health and high dairy diet supplementation on bone status in mothers during pregnancy, and bone health in mothers post-delivery and children to 6 months of age.

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, 36-38 weeks of gestation, and 6 months postpartum 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 to 60 Years
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 15 weeks gestation;
  • a pre pregnancy BMI < 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 or London regional hospital or by home birth and willing to attend research visits at the community site where they were recruited;
  • able to tolerate dairy foods;
  • approval of primary care provider;
  • able to provide signed informed consent.

Exclusion Criteria:

  • unable to understand some English;
  • type 1 or type 2 diabetes;
  • breastfeeding during current pregnancy;
  • pregnancy resulting from in vitro fertilization;
  • known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy;
  • severe gastrointestinal diseases or conditions;
  • any significant heart, kidney, liver or pancreatic diseases;
  • pre-existing diabetes;
  • currently smoking;
  • a depression score above 10 on the validated Edinburgh depression questionnaire.
  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: NCT01689961

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 Family Health Team Recruiting
Hamilton, Ontario, Canada, L8S 1A4
Contact: Keyna Bracken, MD    (905) 521-5016    bracken@mcmaster.ca   
Good Shepherd Women's Services Not yet recruiting
Hamilton, Ontario, Canada, L8R 2Y8
Exercise and Pregnancy Laboratory Recruiting
London, Ontario, Canada, N6A 5C1
Contact: Michelle Mottola, PhD    519-661-2111 ext 85480    mmottola@uwo.ca   
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Agriculture and Agri-Food Canada
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: NCT01689961     History of Changes
Other Study ID Numbers: 12-469
Study First Received: September 13, 2012
Last Updated: March 13, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Nutrition
Physical activity
Gestational weight gain
Pregnancy outcomes
Birth

Additional relevant MeSH terms:
Pregnancy Complications
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014