Gestational Mothers, Weight Gain
Conditions
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.
Interventions
BEHAVIORALMobile 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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| Maternal body fatness post partum | One week post partum | Maternal body fatness 1 week post partum |
| Infant body fatness | One week of age | Infant body fatness at 1 week of age |
| 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 |
Countries
Sweden
Outcome results
None listed