Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02711644 |
| Other study ID # |
Pro00054360 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2015 |
| Est. completion date |
September 2016 |
Study information
| Verified date |
September 2016 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Research has shown that a woman's lifestyle during pregnancy can predict the future health of
a mother and her child. Improving the health of a mother during pregnancy can lead to the
best health outcomes for mother and child in the short and long-term period. Currently there
is a lack of understanding about how best to support women to achieve healthy weights during
pregnancy. The aim of this study is to understand if additional lifestyle support, such as
discussions about healthy eating and physical activity provided by a healthcare provider
throughout pregnancy can help women achieve weights concordant with gestational
recommendations.
The healthcare providers in this study will be Registered Dietitians (RD). The intervention
RD will be trained in Healthy Conversations, a supportive method of communication that
utilizes open-ended questions to support patient-centered behaviour change. This allows women
to explore health issues, identify barriers and discover solutions for improving their own
health. This supportive prenatal counselling will occur with the intervention group
concurrently while completing lifestyle questionnaires with the study RD. During these
conversations, health goals will be made and will be followed up at future visits. The
control group will complete the lifestyle questionnaires with the control RD; they will not
receive additional lifestyle support at these visits. Women will be randomized into one of
the two study groups and will be blinded to their study allocation. All participants will
complete two in person visits and two follow-up telephone calls. Data will be collected on
diet, physical activity, gestational weight gain, delivery, and infant outcomes.
After this research is complete, the investigators hope to better understand the quantity and
quality of additional support that may help women in Alberta achieve guideline concordant
weight gain during pregnancy. If interventions can help women gain weight within the
guidelines, pregnancy-related complications can be reduced. This information is also aimed at
providing a better understanding of healthcare system requirements (i.e., type of providers
and care model) in supporting women achieve healthy weights in pregnancy. The findings from
this project have the potential to improve prenatal healthcare delivery across the province.
Description:
Study Objectives:
1. To examine the efficacy of a supportive prenatal counselling (intervention) vs. standard
prenatal care (control) in promoting appropriate weight gain and dietary intake among
pregnant women.
2. To describe pregnant women's and the RD's perceptions of the strengths, limitations,
effectiveness and satisfaction with the supportive prenatal counselling (intervention)
vs. standard care (control).
Study Design:
Seventy women < 20 weeks gestation will be recruited to participate in this randomized
control trial. Interested women will be screened in person or by telephone by research staff
to determine eligibility. During screening, participants will provide their self-reported
height and pre-pregnancy weight. After eligibility is determined, the eligible participants
will be stratified by pre-pregnancy body mass index (BMI). Block randomization will occur
within each stratum to determine group assignment. Participants will be blinded to their
group assignment, as all participants will follow the same study timeline and the visits will
consist of the same procedures (completing questionnaires, measuring anthropometrics). During
the visit, the control group will take part in routine prenatal care conversations with a
Control RD, while the intervention group will receive conversations framed in a Healthy
Conversations and 5As approach with the (different) RD. This is deemed as supportive prenatal
counselling in our study. The investigators do not anticipate the participants would know the
difference. At time of screening, the Baseline Visit will be scheduled with the respective
RD. One RD will be responsible for participant contact and data collection from each group.
Baseline and follow up appointments will take place at the Clinical Research Unit (CRU)/Human
Nutrition Research Unit (HNRU), 2nd floor of the Li Ka Shing Centre for Health Research
Innovation. All questionnaires used in this study will be online and available either in
RedCap or through ASA24-CANADA-2014 (a specific dietary recall system). All participants will
continue to receive prenatal care through their normal care providers, usually a Family
Physician and/or Obstetrician/Gynecologist.
At the baseline visit, study staff will confirm participant eligibility, answer any
questions, and review the "Information & Consent Form". Women will be asked to provide their
healthcare number and permission to collect information from the Antenatal and Delivery and
Birth records. For each group, the respective RD will guide participants in completing: the
"Baseline Lifestyle Questionnaire" and a ASA24-Hr dietary recall. Each participant's weight
and height will be measured. All participants will be provided with a package of general
printed resources that contain relevant health information for pregnancy. After each visit
and phone call, the RDs will record notes in the participant's study chart. At 28 and 34
weeks gestation, the respective RDs will call the participants to remind them to complete the
dietary recalls and/or book the next clinic visit. For the intervention group, the RD will
follow-up with goals previously set (if any). At approximately 30 weeks gestation, study
visit 2 will occur to complete the "30 Week Lifestyle Questionnaire" for both the
intervention and control groups. At 34 weeks, all participants will be sent the link in their
email to complete the "34 Week Lifestyle Questionnaire" and the ASA-24 Hr recall. At
approximately 4-6 weeks postpartum, all participants will receive a link to the "Postpartum
Questionnaire". Participants in both groups will be asked if they would like to take part in
a post-study focus group to discuss their perceptions of the strengths, limitations,
effectiveness and satisfaction with the study. A separate focus group will be conducted for
each arm of the study and will be facilitated by study staff that is not known to the
participants. Participants who would like to meet with a RD for postpartum nutrition
counselling will have the opportunity to schedule a session; no data collection will occur at
this point.
For the intervention group (n=35), the process of completing the questionnaires and
assessments will be framed using a Healthy Conversation approach. This includes the use of
open-ended questions that enable participant-centered discussions on topics related to
healthy weights, healthy eating, and other lifestyle factors in pregnancy. Discussion topics
will be participant-centered, allowing the participant to guide the conversation. This type
of exploratory counselling allows the participant to understand barriers they face and come
up with solutions that will work within their life. These conversations will be reinforced at
each in-person session and during each telephone follow-up. The intervention group can
contact the study RD and ask questions via phone, email, video call and/or text message
throughout pregnancy. The study team will record the quality and the quantity of all contacts
with each participant.
For the control group (n=35), the RD will help participants complete the questionnaires and
assessments (data collection only) without discussion of specific pregnancy-related topics.
Questions directed at the RD will be answered within the scope of the RD's practice; however,
not additional supportive prenatal counselling will be provided at these study visits.
Participants in the control group will not receive any further follow-up other than the 2
study visits and 2 phone calls.
The investigators will also collect data from the 2 RDs throughout this study. The
intervention RD will complete notes after each contact with participants. The mode of
contact, total minutes, topic of discussion, goals made and amount of minutes a Healthy
Conversation was held with the participants, will be noted. The RDs will ask a random sample
of participants in each arm for permission to audio-record some of their visits to examine
the fidelity and competency of the RD in delivering the intervention using Healthy
Conversation Skills. Both RDs will record their perceptions of the strengths, limitations,
and satisfaction with the study arm they administer to evaluate both protocols through their
visit notes. Additionally, at the end of the study, the RDs will each complete a study
reflection. These notes will be qualitatively analyzed.
