An interventional study of Mobile phone based intervention in Gestational Mothers and Weight Gain, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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
This group will only receive standard care.
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.
Gestational weight gain
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
Body fatness using air-displacement plethysmography
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
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.
Time frame: At the end of the intervention which is 23 weeks after baseline
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)
Time frame: At the end of the intervention which is 23 weeks after baseline
Glycemia
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
Maternal body fatness post partum
Maternal body fatness 1 week post partum
Time frame: One week post partum
Infant body fatness
Infant body fatness at 1 week of age
Time frame: One week of age
Plan to share: No
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Karolinska Institutet