The HealthyMoms Trial to Promote Healthy Gestational Weight Gain

Karolinska Institute

Status: Completed

Conditions: Weight Gain; Gestational Mothers

Treatments: Behavioral: Mobile phone based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03298555

2016-01147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 305 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

305 participants in 2 patient groups

Mobile phone based intervention

Experimental group

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.

Treatment:

Behavioral: Mobile phone based intervention

Control

No Intervention group

Description:

This group will only receive standard care.