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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
January 1, 1970
Maude Perreault et al. (11 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether a structured Nutrition + Exercise intervention, including dairy intake, could help pregnant women achieve recommended gestational weight gain and improve bone health in mothers and offspring.

Results Summary

The study did not report specific results on dairy's effects, but it aimed to assess maternal and infant bone health through biomarkers and DXA scans, suggesting potential benefits of dairy-rich nutrition during pregnancy.

Population

Pregnant women aged >18 years at 12-17 weeks of gestation, excluding those with extreme obesity.

Effective Dosage

Not specified

Duration

Duration of pregnancy (from 12-17 weeks gestation until delivery)

Interactions

None mentioned

Extracted Claims (19)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Excess gestational weight gain (GWG)
increase
the offspring's risk of obesity
offspring
-
may program
#1
Maternal physical activity
neutral
the offspring's risk of obesity
offspring
-
may program
#2
Sub-optimal and excess nutrition during pregnancy
neutral
the offspring's risk of obesity
offspring
-
may program
#3
Maternal intake of dairy foods rich in high-quality proteins, calcium, and vitamin D
neutral
later bone health status
offspring
-
may influence
#4
a novel structured and monitored Nutrition + Exercise intervention
increase
the likelihood of women achieving recommended GWG
pregnant women of all pre-pregnancy weight categories (except extreme obesity)
-
test the effectiveness
#5
a novel structured and monitored Nutrition + Exercise intervention
neutral
bone status of offspring and mother at birth and six months postpartum
pregnant women of all pre-pregnancy weight categories (except extreme obesity) and their offspring
-
test the effectiveness
#6
structured and monitored Nutrition + Exercise (intervention)
increase
the percent of women who achieve GWG within the Institute of Medicine (IOM) guidelines
pregnant women
-
primary outcome
#7
structured and monitored Nutrition + Exercise (intervention)
neutral
maternal bone status via blood bone biomarkers during pregnancy
pregnant women
-
secondary outcome
#8
structured and monitored Nutrition + Exercise (intervention)
neutral
infant bone status in cord blood
infant
-
secondary outcome
#9
structured and monitored Nutrition + Exercise (intervention)
neutral
mother and infant bone status measured by dual-energy absorptiometry scanning (DXA scan) at six months postpartum
mother and infant
-
secondary outcome
#10
structured and monitored Nutrition + Exercise (intervention)
neutral
maternal blood pressure
pregnant women
-
secondary outcome
#11
structured and monitored Nutrition + Exercise (intervention)
neutral
blood glucose and lipid profiles
pregnant women
-
secondary outcome
#12
structured and monitored Nutrition + Exercise (intervention)
neutral
% body fat
pregnant women
-
secondary outcome
#13
structured and monitored Nutrition + Exercise (intervention)
neutral
postpartum weight retention
mother
-
secondary outcome
#14
structured and monitored Nutrition + Exercise (intervention)
neutral
infant weight z-scores
infant
-
secondary outcome
#15
structured and monitored Nutrition + Exercise (intervention)
neutral
fat mass at six months of age
infant
-
secondary outcome
#16
this RCT
neutral
the nutrition guidelines during pregnancy
pregnant women
-
will generate high-quality evidence to refine
#17
this RCT
increase
the likelihood of women achieving recommended GWG
pregnant women
-
will generate high-quality evidence to improve
#18
this RCT
neutral
early nutrition on bone health in the offspring
offspring
-
will demonstrate the importance of
#19
Abstract

BACKGROUND: Evidence from epidemiological and animal studies support the concept of programming fetal, neonatal, and adult health in response to in utero exposures such as maternal obesity and lifestyle variables. Excess gestational weight gain (GWG), maternal physical activity, and sub-optimal and excess nutrition during pregnancy may program the offspring's risk of obesity. Maternal intake of dairy foods rich in high-quality proteins, calcium, and vitamin D may influence later bone health status. Current clinical practice guidelines for managing GWG are not founded on randomized trials and lack specific "active intervention ingredients." The Be Healthy in Pregnancy (BHIP) study is a randomized controlled trial (RCT) designed to test the effectiveness of a novel structured and monitored Nutrition + Exercise intervention in pregnant women of all pre-pregnancy weight categories (except extreme obesity), delivered through prenatal care in community settings (rather than in hospital settings), on the likelihood of women achieving recommended GWG and a benefit to bone status of offspring and mother at birth and six months postpartum. METHODS: The BHIP study is a two-site RCT that will recruit up to 242 participants aged > 18 years at 12-17 weeks of gestation. After baseline measures, participants are randomized to either a structured and monitored Nutrition + Exercise (intervention) or usual care (control) program for the duration of their pregnancy. The primary outcome of the study is the percent of women who achieve GWG within the Institute of Medicine (IOM) guidelines. The secondary outcomes include: (1) maternal bone status via blood bone biomarkers during pregnancy; (2) infant bone status in cord blood; (3) mother and infant bone status measured by dual-energy absorptiometry scanning (DXA scan) at six months postpartum; (4) other measures including maternal blood pressure, blood glucose and lipid profiles, % body fat, and postpartum weight retention; and (5) infant weight z-scores and fat mass at six months of age. DISCUSSION: If effective, this RCT will generate high-quality evidence to refine the nutrition guidelines during pregnancy to improve the likelihood of women achieving recommended GWG. It will also demonstrate the importance of early nutrition on bone health in the offspring. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01689961 Registered on 21 September 2012.

Medical Subject Headings (MeSH)
Age FactorsBone DensityCommunity Health ServicesDairy ProductsDiet, HealthyExerciseFemaleHumansInfantInfant, NewbornMaternal Nutritional Physiological PhenomenaMulticenter Studies as TopicNutritional StatusNutritive ValueOntarioPregnancyPrenatal CareProspective StudiesRandomized Controlled Trials as TopicRecommended Dietary AllowancesTime FactorsTreatment OutcomeWeight Gain
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations20
Citations/Year2.9
Relative Citation Ratio1.43
NIH Percentile63.4%
Research Impact Scores
APT Score0.75
Weight Score1.81
Normalized Score0.67
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