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Promoting Healthy Weights, Lifestyles and Nutrition in Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Danone Institute International
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT02711644
First received: December 22, 2015
Last updated: September 15, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention
Pregnancy
Behavioral: Supportive Lifestyle Counselling
Behavioral: Standard Lifestyle Counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Promoting Healthy Weights, Lifestyles and Nutrition During Pregnancy Through Innovative Counselling Methods

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Weight change from pre-pregnancy to end of pregnancy [ Time Frame: pre-pregnancy, study entry (8-24 weeks gestation), gestational week 30, delivery ]
    difference between self-reported pre-pregnancy weight and highest weight in pregnancy


Secondary Outcome Measures:
  • Type of Labour [ Time Frame: Delivery ]
    from prenatal/delivery record

  • Mother's perceptions of quality of prenatal care [ Time Frame: 1 month Postpartum ]
    Quality of prenatal care Questionnaire (Sword, Heaman 2013)

  • Rate of weight gain [ Time Frame: From pre-pregnancy through delivery ]
    calculated from weights recorded on prenatal record

  • Pregnancy Physical Activity Questionnaire (PPAQ) [ Time Frame: Baseline, week 30 and week 34 gestation ]
    A calculation is provided by the investigators whom created the PPAQ. Each activity is multiplied by an intensity to provide an average weekly energy expenditure.

  • Changes in dietary quality [ Time Frame: Baseline, week 30 and week 34 gestation ]
    Food and nutrient intake determined by 24 hour dietary recall

  • Augmentation used during delivery [ Time Frame: Delivery ]
    from prenatal/delivery record (administration of oxytocin - yes/no)

  • Type of Birth [ Time Frame: Delivery ]
    from prenatal/delivery record

  • Degree of Perineal Tearing [ Time Frame: Delivery ]
    from prenatal/delivery record (degree of Perineal Tearing - nil, 1, 2, 3)

  • Blood loss [ Time Frame: Delivery ]
    from prenatal/delivery record

  • Duration of Labour [ Time Frame: Delivery ]
    from prenatal/delivery record

  • Cord pH [ Time Frame: Delivery ]
    from prenatal/delivery record

  • Meconium Fluid [ Time Frame: Delivery ]
    from prenatal/delivery record

  • Breastfeeding initiation in hospital [ Time Frame: Delivery ]
    from Delivery Record

  • NICU Admission [ Time Frame: Delivery ]
    from Delivery Record

  • Infant sex [ Time Frame: Delivery ]
    from Delivery Record

  • Gestational age at birth [ Time Frame: Delivery ]
    from Delivery Record

  • Infant birth weight [ Time Frame: Delivery ]
    from Delivery Record

  • Infant birth weight percentile [ Time Frame: Delivery ]
    from Delivery Record

  • Infant birth length [ Time Frame: Delivery ]
    from Delivery Record

  • Infant birth length percentile [ Time Frame: Delivery ]
    from Delivery Record

  • APGAR Score [ Time Frame: Delivery ]
    from Delivery Record


Enrollment: 123
Study Start Date: July 2015
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive Lifestyle Counselling
Two supportive lifestyle counselling sessions with Registered Dietitian from study entry to 34 weeks.gestation.
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.
Active Comparator: Standard Lifestyle Counselling
Two standard counselling sessions with Registered Dietitian from study entry to 34 weeks gestation
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02711644

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Danone Institute International
Investigators
Principal Investigator: Rhonda Bell, PhD University of Alberta
Principal Investigator: Donna Manca, MD University of Alberta
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02711644     History of Changes
Other Study ID Numbers: Pro00054360
Study First Received: December 22, 2015
Last Updated: September 15, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Alberta:
Pregnancy
Prenatal
Nutrition

ClinicalTrials.gov processed this record on April 26, 2017