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The HealthyMoms Trial to Promote Healthy Gestational Weight Gain

NCT ID: NCT03298555

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-11-04

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.

Conditions

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Gestational Mothers Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Mobile phone based intervention

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.

Group Type EXPERIMENTAL

Mobile phone based intervention

Intervention Type 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.

Control

This group will only receive standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Marie Löf, docent

Senior researcher, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie Löf, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 36069838 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35963935 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33704075 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33666554 (View on PubMed)

Other Identifiers

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2016-01147

Identifier Type: -

Identifier Source: org_study_id