The HealthyMoms Trial to Promote Healthy Gestational Weight Gain
Primary Purpose
Gestational Mothers, Weight Gain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Mobile phone based intervention
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Mothers
Eligibility 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
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mobile phone based intervention
Control
Arm Description
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.
This group will only receive standard care.
Outcomes
Primary Outcome Measures
Gestational weight gain
Body weight in gestational week 37 minus body weight in gestational week 14
Secondary Outcome Measures
Body fatness using air-displacement plethysmography
Body fatness in gestational week 37 minus body fatness in gestational week 14
Physical activity using accelerometry
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.
Diet quality using a web-based questionnaire
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)
Glycemia
Plasma glucose levels in gestational week 37 minus plasma glucose levels in gestational week 14
Maternal body fatness post partum
Maternal body fatness 1 week post partum
Infant body fatness
Infant body fatness at 1 week of age
Full Information
NCT ID
NCT03298555
First Posted
September 25, 2017
Last Updated
November 5, 2020
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT03298555
Brief Title
The HealthyMoms Trial to Promote Healthy Gestational Weight Gain
Official Title
A Smartphone Application (HealthyMoms) to Promote Healthy Weight Gain, Diet and Physical Activity During Pregnancy: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
November 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Mothers, Weight Gain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
305 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile phone based intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will only receive standard care.
Intervention Type
Behavioral
Intervention Name(s)
Mobile phone based intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational weight gain
Description
Body weight in gestational week 37 minus body weight in gestational week 14
Time Frame
At the end of the intervention which is 23 weeks after baseline
Secondary Outcome Measure Information:
Title
Body fatness using air-displacement plethysmography
Description
Body fatness in gestational week 37 minus body fatness in gestational week 14
Time Frame
At the end of the intervention which is 23 weeks after baseline
Title
Physical activity using accelerometry
Description
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.
Time Frame
At the end of the intervention which is 23 weeks after baseline
Title
Diet quality using a web-based questionnaire
Description
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)
Time Frame
At the end of the intervention which is 23 weeks after baseline
Title
Glycemia
Description
Plasma glucose levels in gestational week 37 minus plasma glucose levels in gestational week 14
Time Frame
At the end of the intervention which is 23 weeks after baseline
Title
Maternal body fatness post partum
Description
Maternal body fatness 1 week post partum
Time Frame
One week post partum
Title
Infant body fatness
Description
Infant body fatness at 1 week of age
Time Frame
One week of age
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Löf, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36069838
Citation
Sandborg J, Migueles JH, Soderstrom E, Blomberg M, Henriksson P, Lof M. Physical Activity, Body Composition, and Cardiometabolic Health during Pregnancy: A Compositional Data Approach. Med Sci Sports Exerc. 2022 Dec 1;54(12):2054-2063. doi: 10.1249/MSS.0000000000002996. Epub 2022 Sep 3.
Results Reference
derived
PubMed Identifier
35963935
Citation
Henriksson P, Migueles JH, Soderstrom E, Sandborg J, Maddison R, Lof M. User engagement in relation to effectiveness of a digital lifestyle intervention (the HealthyMoms app) in pregnancy. Sci Rep. 2022 Aug 13;12(1):13793. doi: 10.1038/s41598-022-17554-9.
Results Reference
derived
PubMed Identifier
33704075
Citation
Sandborg J, Soderstrom E, Henriksson P, Bendtsen M, Henstrom M, Leppanen MH, Maddison R, Migueles JH, Blomberg M, Lof M. Effectiveness of a Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Mar 11;9(3):e26091. doi: 10.2196/26091.
Results Reference
derived
PubMed Identifier
33666554
Citation
Sandborg J, Henriksson P, Larsen E, Lindqvist AK, Rutberg S, Soderstrom E, Maddison R, Lof M. Participants' Engagement and Satisfaction With a Smartphone App Intended to Support Healthy Weight Gain, Diet, and Physical Activity During Pregnancy: Qualitative Study Within the HealthyMoms Trial. JMIR Mhealth Uhealth. 2021 Mar 5;9(3):e26159. doi: 10.2196/26159.
Results Reference
derived
Learn more about this trial
The HealthyMoms Trial to Promote Healthy Gestational Weight Gain
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