Skip to main content
OpenTrials
Completed

NCT Number: NCT03298555

The HealthyMoms Trial to Promote Healthy Gestational Weight Gain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Mothers Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile phone based intervention

Behavioral

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.

Primary outcomes

  1. Gestational weight gain

    Time frame: 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 outcomes

  1. Body fatness using air-displacement plethysmography

    Time frame: 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

  2. Physical activity using accelerometry

    Time frame: 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.

  3. Diet quality using a web-based questionnaire

    Time frame: 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)

  4. Glycemia

    Time frame: 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

  5. Maternal body fatness post partum

    Time frame: One week post partum

    Maternal body fatness 1 week post partum

  6. Infant body fatness

    Time frame: One week of age

    Infant body fatness at 1 week of age

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2017
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.