Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise (BHIP)

• ClinicalTrials.gov Identifier: NCT01689961
• Recruitment Status: Completed
• First Posted: September 21, 2012
• Last Update Posted: October 1, 2020
• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); Agriculture and Agri-Food Canada; Dairy Farmers of Canada
• Information provided by (Responsible Party): McMaster University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pregnancy Complications; Weight Gain	Behavioral: Structured + monitored nutrition and exercise intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 242 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise
• Actual Study Start Date: November 2012
• Actual Primary Completion Date: October 30, 2018
• Actual Study Completion Date: April 30, 2019

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Gestational weight gain within IOM guidelines [ Time Frame: Change from baseline at 38 weeks gestation ]
   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 :

1. Maternal and infant outcomes [ Time Frame: 6 months postpartum ]
   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?
2. Bone health of mother and baby [ Time Frame: 6 months post-partum ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes 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 17 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;
• 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 12 or above on the validated Edinburgh depression questionnaire.

Contacts and Locations

Locations

Canada, Ontario

Burlington Midwives Clinic

Burlington, Ontario, Canada

McMaster Family Health Team

Hamilton, Ontario, Canada, L8S 1A4

Hamilton Midwives Clinics

Hamilton, Ontario, Canada

Exercise and Pregnancy Laboratory

London, Ontario, Canada, N6A 5C1

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Murray-Davis B, Grenier L, Atkinson SA, Mottola MF, Wahoush O, Thabane L, Xie F, Vickers-Manzin J, Moore C, Hutton EK. Experiences regarding nutrition and exercise among women during early postpartum: a qualitative grounded theory study. BMC Pregnancy Childbirth. 2019 Oct 21;19(1):368. doi: 10.1186/s12884-019-2508-z.

Perreault M, Atkinson SA, Mottola MF, Phillips SM, Bracken K, Hutton EK, Xie F, Meyre D, Morassut RE, Prapavessis H, Thabane L; BHIP Study team. Structured diet and exercise guidance in pregnancy to improve health in women and their offspring: study protocol for the Be Healthy in Pregnancy (BHIP) randomized controlled trial. Trials. 2018 Dec 19;19(1):691. doi: 10.1186/s13063-018-3065-x.

• Responsible Party: McMaster University
• ClinicalTrials.gov Identifier: NCT01689961
• Other Study ID Numbers: 12-469
• First Posted: September 21, 2012
• Last Update Posted: October 1, 2020
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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