The HealthyMoms Trial to Promote Healthy Gestational Weight Gain

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Smartphone Application (HealthyMoms) to Promote Healthy Weight Gain, Diet and Physical Activity During Pregnancy: a Randomized Controlled Trial

Conditions
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Gestational Mothers, Weight Gain

Intervention / Treatment
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* Behavioral: Mobile phone based intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile phone based intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>This group will only receive standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain | Body weight in gestational week 37 minus body weight in gestational week 14 | At the end of the intervention which is 23 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fatness using air-displacement plethysmography | Body fatness in gestational week 37 minus body fatness in gestational week 14 | 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. | 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) | 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 | At the end of the intervention which is 23 weeks after baseline | 
| Maternal body fatness post partum | Maternal body fatness 1 week post partum | One week post partum | 
| Infant body fatness | Infant body fatness at 1 week of age | One week of age |