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
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-opti...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2018-12-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-3065-x |
| _version_ | 1819091675859910656 |
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| author | Maude Perreault Stephanie A. Atkinson Michelle F. Mottola Stuart M. Phillips Keyna Bracken Eileen K. Hutton Feng Xie David Meyre Rita E. Morassut Harry Prapavessis Lehana Thabane the BHIP Study team |
| author_facet | Maude Perreault Stephanie A. Atkinson Michelle F. Mottola Stuart M. Phillips Keyna Bracken Eileen K. Hutton Feng Xie David Meyre Rita E. Morassut Harry Prapavessis Lehana Thabane the BHIP Study team |
| author_sort | Maude Perreault |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-21T22:43:30Z |
| format | Article |
| id | doaj.art-a15f2175df2d45a693455e088173ca12 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T22:43:30Z |
| publishDate | 2018-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-a15f2175df2d45a693455e088173ca122022-12-21T18:47:47ZengBMCTrials1745-62152018-12-0119111510.1186/s13063-018-3065-xStructured 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 trialMaude Perreault0Stephanie A. Atkinson1Michelle F. Mottola2Stuart M. Phillips3Keyna Bracken4Eileen K. Hutton5Feng Xie6David Meyre7Rita E. Morassut8Harry Prapavessis9Lehana Thabane10the BHIP Study teamDepartment Pediatrics, HSC 3A44, McMaster UniversityDepartment Pediatrics, HSC 3A44, McMaster UniversitySchool of Kinesiology, Western UniversityDepartment of Kinesiology, McMaster UniversityDepartment of Family Medicine, McMaster UniversityDepartment of Obstetrics & Gynecology, McMaster UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversitySchool of Kinesiology, Western UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityAbstract 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.http://link.springer.com/article/10.1186/s13063-018-3065-xNutritionExerciseRandomized controlled trialPregnancyBoneInfancy |
| spellingShingle | Maude Perreault Stephanie A. Atkinson Michelle F. Mottola Stuart M. Phillips Keyna Bracken Eileen K. Hutton Feng Xie David Meyre Rita E. Morassut Harry Prapavessis Lehana Thabane the 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 Nutrition Exercise Randomized controlled trial Pregnancy Bone Infancy |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Nutrition Exercise Randomized controlled trial Pregnancy Bone Infancy |
| url | http://link.springer.com/article/10.1186/s13063-018-3065-x |
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