Promoting Healthy Weights, Lifestyles and Nutrition in Pregnancy
1 other identifier
interventional
123
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pregnancy
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 22, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJuly 19, 2022
September 1, 2016
1.2 years
December 22, 2015
July 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight change from pre-pregnancy to end of pregnancy
difference between self-reported pre-pregnancy weight and highest weight in pregnancy
pre-pregnancy, study entry (8-24 weeks gestation), gestational week 30, delivery
Secondary Outcomes (21)
Type of Labour
Delivery
Mother's perceptions of quality of prenatal care
1 month Postpartum
Rate of weight gain
From pre-pregnancy through delivery
Pregnancy Physical Activity Questionnaire (PPAQ)
Baseline, week 30 and week 34 gestation
Changes in dietary quality
Baseline, week 30 and week 34 gestation
- +16 more secondary outcomes
Study Arms (2)
Supportive Lifestyle Counselling
EXPERIMENTALTwo supportive lifestyle counselling sessions with Registered Dietitian from study entry to 34 weeks.gestation.
Standard Lifestyle Counselling
ACTIVE COMPARATORTwo standard counselling sessions with Registered Dietitian from study entry to 34 weeks gestation
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Greater than or equal to 20 years of age
- Between 8-20 weeks gestation
- Singleton pregnancy
- Can read and speak English
- Has Internet and telephone access
- Can make the Baseline visit by 24 weeks gestation
- Willingness to provide pre-pregnancy weight and height
- Willingness to provide Alberta Healthcare Number (PHN)
- Willingness to be randomized
- Will be blinded to group allocation.
You may not qualify if:
- Smoker
- Incompetent cervix (previous or present diagnosis)
- Complete/total placenta previa
- Type I, Type II, Gestational Diabetes
- Hypothyroidism (low thyroid function)
- Hyperthyroidism (overactive thyroid)
- Present eating disorder
- Pregnancy-Induced Hypertension (PIH) with adverse features (ie: edema)
- Physical activity is contraindicated
- Currently receiving counselling from a Dietitian
- Currently participating in another lifestyle program
- Receiving prenatal care from a Midwife
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Danone Institute Internationalcollaborator
Study Sites (1)
University of Alberta
Edmonton, Alberta, T6G 2E1, Canada
Related Publications (1)
Adam LM, Manca DP, Bell RC. Can Facebook Be Used for Research? Experiences Using Facebook to Recruit Pregnant Women for a Randomized Controlled Trial. J Med Internet Res. 2016 Sep 21;18(9):e250. doi: 10.2196/jmir.6404.
PMID: 27655184DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Rhonda Bell, PhD
University of Alberta
- PRINCIPAL INVESTIGATOR
Donna Manca, MD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2015
First Posted
March 17, 2016
Study Start
July 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
July 19, 2022
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share