Pregnancy ComplicationsBHIPNCT01689961
Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise
A study testing Structured + monitored nutrition and exercise intervention in people with Pregnancy Complications and Weight Gain, run by McMaster University at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pregnancy Complications, Weight Gain
- What is being tested?
- Structured + monitored nutrition and exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 4 sitesCanada
- Study dates
- Nov 2012to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy pregnant females > 18 years of age with singleton pregnancies (either nulliparous or multiparous);
- less than 17 weeks gestation;
- a pre pregnancy BMI < 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 or London regional hospital or by home birth and willing to attend research visits at the community site where they were recruited;
- able to tolerate dairy foods;
- approval of primary care provider;
- able to provide signed informed consent.
Who cannot join
- unable to understand some English;
- type 1 or type 2 diabetes;
- known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy;
- severe gastrointestinal diseases or conditions;
- any significant heart, kidney, liver or pancreatic diseases;
- pre-existing diabetes;
- currently smoking;
- a depression score 12 or above on the validated Edinburgh depression questionnaire.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Burlington Midwives Clinic
Burlington, Ontario
McMaster Family Health Team
Hamilton, Ontario, L8S 1A4
Hamilton Midwives Clinics
Hamilton, Ontario
Exercise and Pregnancy Laboratory
London, Ontario, N6A 5C1
About this study
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.
Read the 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.
- Conditions
- Pregnancy Complications, Weight Gain
- Being tested
- Structured + monitored nutrition and exercise intervention
- Keywords
- Nutrition, Physical activity, Gestational weight gain, Pregnancy outcomes, Birth
- Medical subject headings
- Pregnancy Complications, Weight Gain, Motor Activity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured + monitored nutrition and exercise interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition+Exercise Intervention | Experimental | 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 Receives: Behavioral: Structured + monitored nutrition and exercise 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 services. In addition, they will be asked to attend 2 focus group sessions exploring women's experiences with exercise, nutrition, and weight gain in pregnancy. Women will receive information about healthy pregnancy from Health Canada. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 gestational weight gain within the IOM guidelines (outcome) over the pregnancy period?
Measured: Change from baseline at 38 weeks gestation
Secondary outcomes (2)
Maternal and infant outcomes
The secondary research question is whether the proposed intervention will result in i) better maternal outcomes (outcome) at 6 months post- partum; and ii) better infant outcomes (outcome) at 6 months post partum?
Measured: 6 months postpartum
Bone health of mother and baby
In mother: plasma/serum measures of bone mineralization and bone resorption and vitamin D status; bone mineral density as measured by dual energy x-ray absorptiometry scan.
In infant: bone mineral content as measured by dual energy x-ray absorptiometry scan.
Measured: 6 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startNov 2012
- Primary completion30 Oct 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Agriculture and Agri-Food Canada, Dairy Farmers of Canada
- Responsible party
- Sponsor
- Investigators
- Stephanie A Atkinson, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689961
- Sponsor's protocol ID
- 12-469
- Acronym
- BHIP
- Status last verified
- Mar 2019
- First submitted
- 13 Sep 2012
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Krzeczkowski JE, Mortaji N, Atkinson S, Schmidt LA, Van Lieshout RJ. Adaptive changes in multiple aspects of emotion regulation in the offspring of pregnant persons receiving a diet-and-exercise intervention relative to usual pregnancy care: a randomized controlled trial. Am J Clin Nutr. 2025 Jan;121(1):50-59. doi: 10.1016/j.ajcnut.2024.10.022. Epub 2024 Oct 30.
PubMed 39486684Mortaji N, Krzeczkowski J, Atkinson S, Amani B, Schmidt LA, Van Lieshout RJ. Early neurodevelopment in the offspring of women enrolled in a randomized controlled trial assessing the effectiveness of a nutrition + exercise intervention on the cognitive development of 12-month-olds. J Dev Orig Health Dis. 2023 Aug;14(4):532-539. doi: 10.1017/S204017442300020X. Epub 2023 Jul 14.
PubMed 37448202Dempsey K, Mottola MF, Atkinson SA. Comparative Assessment of Diet Quality and Adherence to a Structured Nutrition and Exercise Intervention Compared with Usual Care in Pregnancy in a Randomized Trial. Curr Dev Nutr. 2023 May 13;7(6):100097. doi: 10.1016/j.cdnut.2023.100097. eCollection 2023 Jun.
PubMed 37441683Mortaji N, Krzeczkowski J, Atkinson S, Amani B, Schmidt LA, Van Lieshout R. Preliminary findings of emotion regulation in 12-month-old infants of mothers enrolled in a randomized controlled trial assessing a nutrition + exercise intervention. Dev Psychobiol. 2023 Mar;65(2):e22376. doi: 10.1002/dev.22376.
PubMed 36811372Shanmuganathan M, Bogert M, Kroezen Z, Britz-McKibbin P, Atkinson SA. Dynamic Metabolic Signatures of Choline and Carnitine across Healthy Pregnancy and in Cord Blood: Association with Maternal Dietary Protein. J Nutr. 2023 Apr;153(4):999-1007. doi: 10.1016/j.tjnut.2023.02.013. Epub 2023 Feb 11.
PubMed 36780943Perreault M, Mottola MF, Atkinson SA; BHIP study team. Individualized high dairy protein + walking program supports bone health in pregnancy: a randomized controlled trial. Am J Clin Nutr. 2022 Oct 6;116(4):887-896. doi: 10.1093/ajcn/nqac182.
PubMed 35759368Murray-Davis B, Grenier L, Atkinson SA, Mottola MF, Wahoush O, Thabane L, Xie F, Vickers-Manzin J, Moore C, Hutton EK. Experiences regarding nutrition and exercise among women during early postpartum: a qualitative grounded theory study. BMC Pregnancy Childbirth. 2019 Oct 21;19(1):368. doi: 10.1186/s12884-019-2508-z.
PubMed 31638920Perreault M, Atkinson SA, Mottola MF, Phillips SM, Bracken K, Hutton EK, Xie F, Meyre D, Morassut RE, Prapavessis H, Thabane L; 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. 2018 Dec 19;19(1):691. doi: 10.1186/s13063-018-3065-x.
PubMed 30567604
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise
- ClinicalTrials.gov ID
- NCT01689961
- Acronym / sponsor ID
- BHIP / 12-469
- Conditions
- Pregnancy Complications, Weight Gain
- Keywords
- Nutrition, Physical activity, Gestational weight gain, Pregnancy outcomes, Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Agriculture and Agri-Food Canada, Dairy Farmers of Canada
- Study start
- Nov 2012 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition+Exercise Intervention | Experimental | Behavioral: Structured + monitored nutrition and exercise interventionStructured + 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 |
| 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 services. In addition, they will be asked to attend 2 focus group sessions exploring women's experiences with exercise, nutrition, and weight gain in pregnancy. Women will receive information about healthy pregnancy from Health Canada. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy pregnant females > 18 years of age with singleton pregnancies (either nulliparous or multiparous);
- less than 17 weeks gestation;
- a pre pregnancy BMI < 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 or London regional hospital or by home birth and willing to attend research visits at the community site where they were recruited;
- able to tolerate dairy foods;
Key exclusion criteria (8 listed)
- unable to understand some English;
- type 1 or type 2 diabetes;
- known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy;
- severe gastrointestinal diseases or conditions;
- any significant heart, kidney, liver or pancreatic diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured + monitored nutrition and exercise interventionThe 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. | Behavioural | Nutrition+Exercise Intervention |
Primary outcome
Gestational weight gain within IOM guidelines
Time frame: Change from baseline at 38 weeks gestation
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 gestational weight gain within the IOM guidelines (outcome) over the pregnancy period?
2 secondary outcomes
Maternal and infant outcomes
Time frame: 6 months postpartum
Bone health of mother and baby
Time frame: 6 months post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Derived from this study: PubMed 39486684Krzeczkowski JE, Mortaji N, Atkinson S, Schmidt LA, Van Lieshout RJ. Adaptive changes in multiple aspects of emotion regulation in the offspring of pregnant persons receiving a diet-and-exercise intervention relative to usual pregnancy care: a randomized controlled trial. Am J Clin Nutr. 2025 Jan;121(1):50-59. doi: 10.1016/j.ajcnut.2024.10.022. Epub 2024 Oct 30.
- Derived from this study: PubMed 37448202Mortaji N, Krzeczkowski J, Atkinson S, Amani B, Schmidt LA, Van Lieshout RJ. Early neurodevelopment in the offspring of women enrolled in a randomized controlled trial assessing the effectiveness of a nutrition + exercise intervention on the cognitive development of 12-month-olds. J Dev Orig Health Dis. 2023 Aug;14(4):532-539. doi: 10.1017/S204017442300020X. Epub 2023 Jul 14.
- Derived from this study: PubMed 37441683Dempsey K, Mottola MF, Atkinson SA. Comparative Assessment of Diet Quality and Adherence to a Structured Nutrition and Exercise Intervention Compared with Usual Care in Pregnancy in a Randomized Trial. Curr Dev Nutr. 2023 May 13;7(6):100097. doi: 10.1016/j.cdnut.2023.100097. eCollection 2023 Jun.
- Derived from this study: PubMed 36811372Mortaji N, Krzeczkowski J, Atkinson S, Amani B, Schmidt LA, Van Lieshout R. Preliminary findings of emotion regulation in 12-month-old infants of mothers enrolled in a randomized controlled trial assessing a nutrition + exercise intervention. Dev Psychobiol. 2023 Mar;65(2):e22376. doi: 10.1002/dev.22376.
- Derived from this study: PubMed 36780943Shanmuganathan M, Bogert M, Kroezen Z, Britz-McKibbin P, Atkinson SA. Dynamic Metabolic Signatures of Choline and Carnitine across Healthy Pregnancy and in Cord Blood: Association with Maternal Dietary Protein. J Nutr. 2023 Apr;153(4):999-1007. doi: 10.1016/j.tjnut.2023.02.013. Epub 2023 Feb 11.
- Derived from this study: PubMed 35759368Perreault M, Mottola MF, Atkinson SA; BHIP study team. Individualized high dairy protein + walking program supports bone health in pregnancy: a randomized controlled trial. Am J Clin Nutr. 2022 Oct 6;116(4):887-896. doi: 10.1093/ajcn/nqac182.
- Derived from this study: PubMed 31638920Murray-Davis B, Grenier L, Atkinson SA, Mottola MF, Wahoush O, Thabane L, Xie F, Vickers-Manzin J, Moore C, Hutton EK. Experiences regarding nutrition and exercise among women during early postpartum: a qualitative grounded theory study. BMC Pregnancy Childbirth. 2019 Oct 21;19(1):368. doi: 10.1186/s12884-019-2508-z.
- Derived from this study: PubMed 30567604Perreault M, Atkinson SA, Mottola MF, Phillips SM, Bracken K, Hutton EK, Xie F, Meyre D, Morassut RE, Prapavessis H, Thabane L; 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. 2018 Dec 19;19(1):691. doi: 10.1186/s13063-018-3065-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie A Atkinson, PhD principal investigator
McMaster University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured + monitored nutrition and exercise intervention in people with Pregnancy Complications and Weight Gain, run by McMaster University at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational weight gain within IOM guidelines (time frame: Change from baseline at 38 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01689961, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.