The HealthyMoms Trial to Promote Healthy Gestational Weight Gain

NCT03298555 | Completed

• 1 other identifier: 2016-01147
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Mothers; Weight Gain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Body fatness using air-displacement plethysmography

  At the end of the intervention which is 23 weeks after baseline

• Physical activity using accelerometry

  At the end of the intervention which is 23 weeks after baseline

• Diet quality using a web-based questionnaire

  At the end of the intervention which is 23 weeks after baseline

• Glycemia

  At the end of the intervention which is 23 weeks after baseline

• Maternal body fatness post partum

  One week post partum

Study Arms (2)

Mobile phone based intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

This group will only receive standard care.

Interventions

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.

Mobile phone based intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a single pregnancy
• aged 18 years or above
• be able to speak and read Swedish sufficiently well.

You may not qualify if:

• previous diagnosed eating disorder
• pre-pregnancy diabetes or medical conditions or pharmacological treatments prior to pregnancy that may affect body weight

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (4)

• Sandborg J, Migueles JH, Soderstrom E, Blomberg M, Henriksson P, Lof M. Physical Activity, Body Composition, and Cardiometabolic Health during Pregnancy: A Compositional Data Approach. Med Sci Sports Exerc. 2022 Dec 1;54(12):2054-2063. doi: 10.1249/MSS.0000000000002996. Epub 2022 Sep 3.

  PMID: 36069838 DERIVED

• Henriksson P, Migueles JH, Soderstrom E, Sandborg J, Maddison R, Lof M. User engagement in relation to effectiveness of a digital lifestyle intervention (the HealthyMoms app) in pregnancy. Sci Rep. 2022 Aug 13;12(1):13793. doi: 10.1038/s41598-022-17554-9.

  PMID: 35963935 DERIVED

• Sandborg J, Soderstrom E, Henriksson P, Bendtsen M, Henstrom M, Leppanen MH, Maddison R, Migueles JH, Blomberg M, Lof M. Effectiveness of a Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Mar 11;9(3):e26091. doi: 10.2196/26091.

  PMID: 33704075 DERIVED

• Sandborg J, Henriksson P, Larsen E, Lindqvist AK, Rutberg S, Soderstrom E, Maddison R, Lof M. Participants' Engagement and Satisfaction With a Smartphone App Intended to Support Healthy Weight Gain, Diet, and Physical Activity During Pregnancy: Qualitative Study Within the HealthyMoms Trial. JMIR Mhealth Uhealth. 2021 Mar 5;9(3):e26159. doi: 10.2196/26159.

  PMID: 33666554 DERIVED

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Löf, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, associate professor

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 2, 2017
• Study Start: October 1, 2017
• Primary Completion: September 30, 2020
• Study Completion: November 4, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)