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
|Condition or disease||Intervention/treatment||Phase|
|Gestational Mothers Weight Gain||Behavioral: Mobile phone based intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|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|
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.
- 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
- 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
- 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.
- 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)
- 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
- Maternal body fatness post partum [ Time Frame: One week post partum ]Maternal body fatness 1 week post partum
- Infant body fatness [ Time Frame: One week of age ]Infant body fatness at 1 week of age
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
|Contact: Marie Löf, PhD||+46 firstname.lastname@example.org|
|Contact: Marie Löf email@example.com|
|Principal Investigator:||Marie Löf, PhD||Karolinska Institutet|