Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise
Condition: Pregnancy Complications; Weight Gain
MeSH terms: Pregnancy Complications; Weight Gain
Study type: Interventional

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.
    

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.
    

Intervention name(s): Structured + monitored nutrition and exercise intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nutrition; Physical activity; Gestational weight gain; Pregnancy outcomes; Birth