The HealthyMoms Trial to Promote Healthy Gestational Weight Gain

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298555
• Other study ID #: 2016-01147
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: November 4, 2020

Study information

• Verified date: November 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: November 4, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Gestational Mothers
• Weight Gain

Intervention

Behavioral:
• Mobile 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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal body fatness post partum	Maternal body fatness 1 week post partum	One week post partum
Secondary	Infant body fatness	Infant body fatness at 1 week of age	One week of age