Be Healthy in Pregnancy (B-HIP): A Trial to Study Nutrition and Exercise Approaches for Healthy Pregnancy

NCT01693510 | Completed DMC

• 1 other identifier: BHIP-DFC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Weight gained during pregnancy is referred to as gestational weight gain (GWG). Excess GWG is a widespread problem that occurs in 55-75% of Canadian women who enter pregnancy overweight or obese (a group that represents over 50 % of all pregnant women) and about 40% women of normal weight. Excess GWG is associated with complications of pregnancy, such as post-partum weight retention, type 2 diabetes, elevated fats in the blood, and high blood pressure and may also lead to problems with the health of the newborn child. Our research aims to find ways to control GWG by developing new and practical approaches to diet and exercise targeted to overweight pregnant women that hold promise of improving their health both during pregnancy and thereafter. The experimental intervention is a diet of higher protein provided by dairy foods combined with an exercise program modified to the abilities of overweight pregnant women; and the control is the usual advice given by their primary care providers, information on healthy pregnancy from Health Canada, and a focus group session exploring women's experiences with exercise, nutrition, and gestational weight gain. The results of this study will allow us to design future large clinical studies in all pregnant women to help control the weight gain in all pregnant women.

Conditions

Excessive Weight Gain in Pregnancy as Antepartum Condition; Obesity; Weight Gain; Type 2 Diabetes

Keywords

Excess gestational weight gain (GWG); Obesity; Type 2 diabetes; Elevated fats in the blood; High blood pressure

Outcome Measures

Primary Outcomes (1)

• Gestational weight gain within IOM guidelines

  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 GWG within the IOM guidelines (outcome) over the pregnancy period?

  Change from baseline at 38 weeks gestation

Secondary Outcomes (1)

• Bone outcomes

  6 months post-partum

Study Arms (2)

Exercise and Nutrition Intervention

EXPERIMENTAL

Nutrition intervention: The proposed nutrition plan is a high protein (25% energy) diet providing low fat dairy foods and individualized to energy needs. Dairy foods are accepted by women during pregnancy as a healthy choice (from pilot study) and in our recent birth cohort study, women consumed an average of 3 or more servings of dairy per day. Exercise intervention: Most previous studies and published guidance focus on aerobic exercise such as walking as it is the easiest physical activity to implement in pregnancy in terms of setting goals of steps and monitoring of adherence using accelerometer-type devices. Walking is also the most practical since women reduced moderate and vigorous physical activity during pregnancy but levels of walking were maintained.

Behavioral: Exercise and Nutrition Intervention

Usual Prenatal Care

NO INTERVENTION

Mothers in the Control Group will be followed by their primary care provider and have usual access to public health. In addition, women will have the opportunity to attend one focus group session exploring women's experiences with nutrition, exercise, and weight gain in pregnancy.

Interventions

Exercise and Nutrition Intervention BEHAVIORAL

Both Intervention and Control participants and their care providers receive the new Health Canada guide on Healthy Weight Gain During Pregnancy. For the Experimental Group, 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 to reach 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.

Exercise and Nutrition Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy pregnant females \> 18 years of age with singleton pregnancies (either nulliparous or multiparous); less than 20 weeks gestation; pre-pregnancy BMI of \>25 and \< 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 Health Sciences, St. Joseph's Healthcare Hamilton, Joseph Brant Hospital or by home birth but willing to attend research visits at the McMaster University Medical Centre site; approval of primary care provider; and able to provide signed informed consent.

You may not qualify if:

• Unable to understand some English; currently breastfeeding previous child; pregnancy resulting from in vitro fertilization; known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy; severe chronic gastrointestinal diseases or conditions; refusal to consume dairy foods due to intolerance or dislike; any significant heart, kidney, liver or pancreatic diseases; pre-existing diabetes; or a depression score above 13 on the validated Edinburgh Depression scale as that is indicative of severe depression and should be referred for treatment; currently smoking.

Sponsors & Collaborators

• McMaster University: lead
• Dairy Farmers of Canada: collaborator

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (3)

• Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

  PMID: 39077939 DERIVED

• Maran A, Atkinson SA, Bertram V, Vanniyasingam T, Thabane L, Mottola MF, Phillips SM; BHIP study team. Exploring comparative assessment of adiposity measures during pregnancy and postpartum. Clin Nutr ESPEN. 2022 Jun;49:365-371. doi: 10.1016/j.clnesp.2022.03.021. Epub 2022 Mar 23.

  PMID: 35623838 DERIVED

• Perreault M, Atkinson SA, Meyre D, Fusch G, Mottola MF; BHIP Study Team. Summer Season and Recommended Vitamin D Intake Support Adequate Vitamin D Status throughout Pregnancy in Healthy Canadian Women and Their Newborns. J Nutr. 2020 Apr 1;150(4):739-746. doi: 10.1093/jn/nxz276.

  PMID: 31732740 DERIVED

MeSH Terms

Conditions

Obesity; Weight Gain; Diabetes Mellitus, Type 2; Hypertension

Interventions

Exercise; Diet Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy; Therapeutics

Study Officials

• Stephanie A. Atkinson, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 26, 2012
• Study Start: November 12, 2012
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2019
• Last Updated: October 1, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)