Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise

NCT01689961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2020-10-01

No results posted yet for this study

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.

Conditions

  • Pregnancy Complications
  • Weight Gain

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Agriculture and Agri-Food Canada

    collaborator OTHER_GOV
  • Dairy Farmers of Canada

    collaborator OTHER
  • McMaster University

    lead OTHER

Principal Investigators

  • Stephanie A Atkinson, PhD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2018-10-30
Completion
2019-04-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01689961 on ClinicalTrials.gov