Promoting Healthy Weights, Lifestyles and Nutrition in Pregnancy

NCT02711644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2022-07-19

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

BEHAVIORAL

Supportive Lifestyle Counselling

Each participant will meet with the intervention Registered Dietitian twice in pregnancy and have two follow-up phone calls. Participants in this group will have on-going, supportive discussions with the intervention Registered Dietitian about healthy lifestyles in pregnancy. Discussion topics with the intervention Registered Dietitian at each visit will be participant-centered, allowing the participant to guide the conversation. These conversations will be reinforced at every future contact made throughout pregnancy.

BEHAVIORAL

Standard Lifestyle Counselling

Each participant will meet in person with their respective Registered Dietitian twice in pregnancy and have two follow-up phone calls. At these visits, each participant will complete questionnaires and have anthropometric assessments (height/weight). From home, each participant will also complete online questionnaires at week 26, and week 34. Postpartum,each participant will complete an online questionnaire. Optional postpartum participation includes a focus group in the postpartum period and the option to meet with a Registered Dietitian postpartum.

Sponsors & Collaborators

  • Danone Institute International

    collaborator OTHER
  • University of Alberta

    lead OTHER

Principal Investigators

  • Rhonda Bell, PhD · University of Alberta

  • Donna Manca, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02711644 on ClinicalTrials.gov