Clinical trial NCT03298555: The HealthyMoms Trial to Promote Healthy Gestational Weight Gain
Official title: A Smartphone Application (HealthyMoms) to Promote Healthy Weight Gain, Diet and Physical Activity During Pregnancy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Mothers
Weight Gain
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 305
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gestational weight gain
timeFrame: At the end of the intervention which is 23 weeks after baseline
Secondary outcomes:
measure: Body fatness using air-displacement plethysmography
timeFrame: At the end of the intervention which is 23 weeks after baseline
measure: Physical activity using accelerometry
timeFrame: At the end of the intervention which is 23 weeks after baseline
measure: Diet quality using a web-based questionnaire
timeFrame: At the end of the intervention which is 23 weeks after baseline
measure: Glycemia
timeFrame: At the end of the intervention which is 23 weeks after baseline
measure: Maternal body fatness post partum
timeFrame: One week post partum
measure: Infant body fatness
timeFrame: One week of age
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Marie Löf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.