Main objective is to assess the effectiveness of SP+ in an almost real-life setting of a randomised controlled trial (RCT) in 930 women with obesity, using CVMD-score as primary outcome measurement. Secondary aim is to assess the cost-effectiveness…
ID
Source
Brief title
Condition
- Other condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Health condition
Obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary composite outcome used for the effectiveness is incidence of CVMD
(hypertensive pregnancy complications, chronic hypertension, diabetes
gravidarum, type I and II diabetes) during the 12 months study period.
Secondary outcome
Secondary outcomes are maternal outcomes, neonatal outcomes, cost-effectiveness.
Tertiary outcomes are user satisfaction, reimbursement and implementation
roadmaps.
Background summary
Obesity is a chronic disease and is associated with cardiovascular and
metabolic disease (CVMD) as comorbidities. (1) Pregnancy is a stressor for the
cardiovascular and metabolic health of the mother in general, and in particular
in obese women. Around 50% of pregnant women is overweight or obese, with 25%
developing the CVMD symptoms during pregnancy, and face a 10-fold higher risk
of CVMD within 10 years after pregnancy. (2) Since a poor lifestyle and a poor
living environment are known risk factors for CVMD(3, 4), lifestyle care
integrated in pregnancy care and involving the partner is a promising approach
for the sec-ondary prevention of CVMD and other obesity-related complications
during this critical phase of life. Integration of lifestyle care in pregnancy
care for obese women faces three main chal-lenges: 1) Sustainable adoption of
healthy lifestyle behaviour through an intervention that is inclusive and
considers the own living environment, health and digital literacy and
socio-economic status (SES); 2) Implementation of the intervention in the
pregnancy care system while avoiding increase of workload for healthcare
providers (HCPs); and 3) Convincing evi-dence to justify reimbursement of the
lifestyle intervention by national health care insurances. We present
SmarterPregnancy+ (SP+), a digital lifestyle care path opti-mised for women
with obesity, as a solution. SP+ supports a sustainable behavioural change
through lifestyle and exercise-promoting nudging. Here, we aim to demonstrate
the cost-effectiveness of this solution in the Dutch pregnancy care system and
pave the way towards national reimbursement within the basic health insurance
package and implementation.
Study objective
Main objective is to assess the effectiveness of SP+ in an almost real-life
setting of a randomised controlled trial (RCT) in 930 women with obesity, using
CVMD-score as primary outcome measurement.
Secondary aim is to assess the cost-effectiveness of SP+. Tertiary aim is to
develop a roadmap for reimbursement and implementation together with
stakeholders in which technological and end-user conditions for use of SP+ as a
digital intervention in the Dutch pregnancy care system will be set, and the
requirements, barriers and facilitators for imple-mentation, adoption and
sustainability will be assessed, defined and laid down in a budget im-pact
analysis.
Study design
A randomised controlled trial, conducted at a primary, secondary and tertiary
pregnancy care setting.
Intervention
The intervention group receives SP+, while the control group receives Care as
Usual.
Intervention: The 6-month lifestyle care path SP+ involves coaching on healthy
nutrition, folic acid and vitamin D supplement use, physical activity, mental
health and stop smoking and alcohol use, optimized according to the needs and
values of these women with obesity and vulnerable conditions. The intervention
uses the already existing program Smarter Pregnancy (SP) as starting point. SP
will be transformed into a mobile application, with a complete revision and
adaptation tailored for women with obesity (and their partner).This includes
adjustments in language, behavior change techniques, and content within the
app. Existing modules focused on fruit, vegetable, folic acid, alcohol, and
tobacco intake are being expanded to include modules on physical activity and
mental health. New functionalities are also being added, such as a read-aloud
feature, a habit diary for tracking personal habits, videos, exercises, and
more background information on healthy habits. Furthermore, information,
questions and tips will be rewritten and provided via push message and users
will be given the opportunity to personalize the frequency and timing of these
messages. This will be combined with one or two video coaching sessions with a
research team member in which users can ask questions and receive additional
advice.
Control: the control group receives standard of care, which might include
information on lifestyle. This group does not receive SP+ or video coaching.
Information on lifestyle (and other study out-comes) will be obtained through
Castor.
Study burden and risks
Since this intervention solely consists of lifestyle coaching, the risks are
negligible and the burden minimal. In addition, the intervention is based on
the non-invasive, certified and publicly available website Slimmer Zwanger
(www.slimmerzwanger.nl or www.smarterpregnancy.co.uk). This program has been
recognized as cost-effective and safe in changing lifestyle habits by the
Rijksinstituut voor Volksgezondheid en Milieu (RIVM) in 2020 (5) based on the
results of prior studies. (6-13) The current intervention is an improved,
extended and adjusted version of this program for women with obesity and will
focus on pregnancy outcomes.
The total duration of participation is 52 weeks. In this period, the
intervention group will re-ceive 6 months of SP+. A detailed description of
the content of SP+ can be found in section 5.1 in this protocol. In summary its
content includes a 5-minute baseline screening on person-al conditions (e.g.,
gender, age, pregnancy state, gestational age, body mass index, zip code) and
lifestyle (nutrition, folic acid, alcohol, smoking, physical exercise, mental
health). Based on these conditions and lifestyle behaviors, the algorithm
generates a personalized coaching path of 6 months which is complemented by one
or two video-coaching sessions. To assess the change of the lifestyle behaviors
and habits, participants receive a 5-minute monitoring questionnaire at t= 6,
12, 18 and 26 weeks and at the end of the RCT at week 52.
To assess the costs, quality of life and behavioral change, participants will
receive 20 to 30-minute study questionnaires at three time points, see figure 1
and 2 for details. Furthermore, medical files will be requested. In addition, a
selection of ±20 women will be followed during their patient journey and asked
to participate in interviews and focus groups. For this selec-tion of women,
the consumption of care and interaction with HCPs will also be timed. Health
care providers and stakeholders will also be asked to participate in interviews
and focus groups.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in target group 1, a subject must meet all the
following criteria. Women are eligible to participate if:
- they are above 18 years of age,
- they have a body mass index (BMI) >=30 (BMI is classified according to World
Health Organization criteria for adults)
- they have a singleton pregnancy of less than 3 months,
- they have sufficient understanding of the Dutch or English language,
- they have access to a smartphone or tablet,
- they have provided informed consent for participation.
The partner of the women randomized in the intervention group be invited to
participate to involve the close living environment of the woman (intrinsic and
extrinsic motivation). The participation of the partner is voluntary. Partners
are eligible to participate if:
- they are partner of a participating pregnant woman in the intervention group
- they are above 18 years of age,
- they have sufficient understanding of the Dutch or English language,
- they have provided informed consent for participation (PIF partners).
Health care providers for target group 2 are eligible if they are involved in
the implementation of SP+ and obstetric care. Stakeholders are invited based on
their expertise on SP+, technology in general and obesity care. They must
provide informed consent for participation after reading the patient
information folder.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- not able to give written informed consent
- insufficient understanding of the Dutch or English language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87213.078.24 |