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Gestational MothersNCT03298555

The HealthyMoms Trial to Promote Healthy Gestational Weight Gain

A study testing Mobile phone based intervention in people with Gestational Mothers and Weight Gain, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Mothers, Weight Gain
What is being tested?
Mobile phone based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
1 siteSweden
Study dates
1 Oct 2017to 4 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institutet

    Stockholm

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Mobile phone based intervention
Medical subject headings
Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile phone based interventionBehavioural

    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.

Study groups in NCT03298555
Study groupRoleWhat they receive
Mobile phone based interventionExperimentalThis 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.
Receives: Behavioral: Mobile phone based intervention
ControlNo interventionThis group will only receive standard care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gestational weight gain

    Body weight in gestational week 37 minus body weight in gestational week 14

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

Secondary outcomes (6)

  1. Body fatness using air-displacement plethysmography

    Body fatness in gestational week 37 minus body fatness in gestational week 14

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

  2. 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.

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

  3. 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)

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

  4. Glycemia

    Plasma glucose levels in gestational week 37 minus plasma glucose levels in gestational week 14

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

  5. Maternal body fatness post partum

    Maternal body fatness 1 week post partum

    Measured: One week post partum

  6. Infant body fatness

    Infant body fatness at 1 week of age

    Measured: One week of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start1 Oct 2017
  3. Primary completion30 Sep 2020
  4. Study completion4 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298555
Sponsor's protocol ID
2016-01147
Other IDs
2016
Status last verified
Nov 2020
First submitted
25 Sep 2017
Last updated
6 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36069838

  • 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.

    PubMed 35963935

  • 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.

    PubMed 33704075

  • 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.

    PubMed 33666554

Questions about this trial

What is this clinical trial studying?

A study testing Mobile phone based intervention in people with Gestational Mothers and Weight Gain, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational weight gain (time frame: At the end of the intervention which is 23 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298555, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.

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