The HealthyMoms Trial to Promote Healthy Gestational Weight Gain

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Mobile phone based intervention	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.

Primary Outcome Measures

Name	Time	Method
Gestational weight gain	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

Name	Time	Method
Glycemia	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	One week post partum	Maternal body fatness 1 week post partum
Body fatness using air-displacement plethysmography	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	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	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)
Infant body fatness	One week of age	Infant body fatness at 1 week of age