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The HealthyMoms Trial to Promote Healthy Gestational Weight Gain

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ClinicalTrials.gov Identifier: NCT03298555
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Marie Löf, docent, Karolinska Institutet

Brief Summary:
Excessive gestational weight gain is a major public health problem. Traditional face-to-face intervention programs has been shown to be succesful in order to promote healthier weight gains, however, they are time-consuming and expensive. The objectives of this study are to assess whether a 6-month smartphone application can promote healthy gestational weight gain, dietary habits and physical activity in pregnant women.

Condition or disease Intervention/treatment Phase
Gestational Mothers Weight Gain Behavioral: Mobile phone based intervention Not Applicable

Detailed Description:

Excessive gestational weight gain (GWG) increases risks for pregnancy complications, postpartum weight retention and offspring obesity. Traditional intervention programs are time and cost intensive. Mobile technology (mHealth) has been successful for weight loss and behavior changes; however, their use in pregnancy need to be further examined. This study aims to evaluate the impact of a smartphone application (app) intervention on GWG, diet, physical activity and glucose homeostasis.

HealthyMoms is a randomized controlled trial recruiting women at the first maternity clinic visit (week 6-10) in the Linköping area, Sweden. Women will be randomized to the control or intervention group (n=150 per group). All women will receive standard care. The intervention group will also receive the HealthyMoms smartphone app promoting healthy eating, activity and GWG during 6 months. Pregnancy outcomes are GWG (primary), food intake (web-based questionnaire), fat mass (BodPod), glucose homeostasis, activity (accelerometer) in week 37. Maternal and infant body fatness will be assessed one week post partum.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Smartphone Application (HealthyMoms) to Promote Healthy Weight Gain, Diet and Physical Activity During Pregnancy: a Randomized Controlled Trial
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Mobile phone based intervention
This group will receive the smartphone app HealthyMoms between gestational week 14 and 37. The app will contain information and support to achieve a healthy weight gain and lifestyle during pregnancy. This group will also receive standard care.
Behavioral: Mobile phone based intervention
Participants in the intervention group will receive a 6-month mobile phone based program via a mobile phone application specifically designed for this study. The program will include information, advice and strategies to promote healthy gestational weight gain.

No Intervention: Control
This group will only receive standard care.



Primary Outcome Measures :
  1. Gestational weight gain [ Time Frame: At the end of the intervention which is 23 weeks after baseline ]
    Body weight in gestational week 37 minus body weight in gestational week 14


Secondary Outcome Measures :
  1. Body fatness using air-displacement plethysmography [ Time Frame: At the end of the intervention which is 23 weeks after baseline ]
    Body fatness in gestational week 37 minus body fatness in gestational week 14

  2. Physical activity using accelerometry [ Time Frame: At the end of the intervention which is 23 weeks after baseline ]
    Moderate-to-vigorous physical activity (MVPA) in gestational week 37 minus MVPA in gestational week 14. MVPA will be assessed using wrist-worn accelerometry (Actigraph wGT3x) during 7 days at both time points.

  3. Diet quality using a web-based questionnaire [ Time Frame: At the end of the intervention which is 23 weeks after baseline ]
    Diet quality in gestational week 37 minus diet quality in gestational week 14. Diet quality will be assessed using a web-based questionnaire (a combination of a food-frequency questionnaire and two 24 hour recalls)

  4. Glycemia [ Time Frame: At the end of the intervention which is 23 weeks after baseline ]
    Plasma glucose levels in gestational week 37 minus plasma glucose levels in gestational week 14

  5. Maternal body fatness post partum [ Time Frame: One week post partum ]
    Maternal body fatness 1 week post partum

  6. Infant body fatness [ Time Frame: One week of age ]
    Infant body fatness at 1 week of age



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a single pregnancy
  • aged 18 years or above
  • be able to speak and read Swedish sufficiently well.

Exclusion Criteria:

  • previous diagnosed eating disorder
  • pre-pregnancy diabetes or medical conditions or pharmacological treatments prior to pregnancy that may affect body weight

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298555


Contacts
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Contact: Marie Löf, PhD +46 734426417 marie.lof@ki.se

Locations
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Sweden
Karolinska Institutet Recruiting
Stockholm, Sweden
Contact: Marie Löf       marie.lof@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Marie Löf, PhD Karolinska Institutet

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Responsible Party: Marie Löf, docent, Senior researcher, associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03298555     History of Changes
Other Study ID Numbers: 2016-01147
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Weight Gain
Signs and Symptoms
Body Weight Changes