Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM)
Condition: Pregnancy-Related Condition, Unspecified; Overweight or Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Maternal obesity increases risks for the mother and her child. It is crucial to arouse the
      pregnant and postpartum women´s willingness of change and motivation to take care of their
      own and their unborn child´s health. Wearable devices can be helpful for weight-management,
      e.g. in improving participant's self-efficacy in making healthy behavior changes, improving
      self-awareness, in goal setting and getting feedback. More comprehensive research is required
      to implement the optimal weight-management intervention for overweight women during pregnancy
      and the postpartum period and to develop appropriate and feasible implementation strategies
      to support nurses to deliver interventions in maternity clinics.

      The aim of this study is to evaluate the effectiveness of the Supporting Lifestyle Change in
      Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM) intervention. Secondary aim
      is to evaluate the implementation of SLIM intervention in maternity care.

      Intervention was developed based on findings of overweight women and their care givers
      interview study. The intervention targeting overweight pregnant women to improve their
      weight-management will be delivered during routine perinatal visits from the first visit to
      three months after child birth. Interventions core components will be goalsetting,
      motivational interviewing, feedback and health technology. Health technology includes
      Oura-ring and ZotCare -application. ZotCare -application combines data from Oura Smart Ring,
      electronic food diary and it´s also platform for researchers to send e.g. questionnaires and
      surveys to participants. Oura-smartring is an advanced technology ring that monitors e.g.
      heart rate, heart rate variability (HRV), steps, body temperature and sleep) and a smartphone
      application that includes data from Oura, and electronic food diary. Data collected with Oura
      -smartrings will be transmitted to cloud servers via a smartphone. The cloud will be
      responsible for storing the data and for performing the data preprocessing and analysis
      methods. Interventions primary outcome will be self-efficacy. Secondary outcomes will be
      womens weight, depression symptoms, quality of life, pregnancy anxiety, perceived stress,
      sence of coherence and acceptability, appropriateness and feasibility of Intervention.

      Data will be collected via Oura smartring, electronic food diary and validated measures:
      Weight Efficacy Life-Style Questionnaire (WEL), Self-Efficacy for Physical Activity Scale
      (PASE), six-factor questionnaire (6-FQ), Three Factor Eating Questionnaire (TFEQ-R18),
      WHOQOL-BREF, Sense of coherence (SOC-13), Pregnancy anxiety (PRAQ-R2), Perceived stress and
      Edinburgh Postnatal Depression scale (EPDS). Intervention implementation will be evaluated
      with process evaluation. Data will be collected from public health nurses working in
      maternity clinics using focus group interviews and workshops.
    

Detailed description: 
      Maternal obesity increases risks for the mother and her child. It is crucial to arouse the
      pregnant and postpartum women´s willingness of change and motivation to take care of their
      own and their unborn child´s health. Researchers have suggested that reﬁning the pre-existing
      prenatal care models, possibly incorporating diet and physical activity into interventions,
      could be useful. Continuous monitoring can provide real-time information between scheduled
      appointments and thus may be helpful for targeting and tailoring pregnancy follow-up.
      Wearable devices can be helpful for weight-management, e.g. in improving participant's
      self-efficacy in making healthy behavior changes, improving self-awareness, in goal setting
      and getting feedback. However, it's very important to identify and tailor the intervention
      into individual motivations in order to facilitate technology adoption. Technological
      solutions designed for the pregnant women, can balance the gap between limited resources and
      growing demand of maternity care service. More comprehensive research is required to
      implement the optimal weight-management intervention for overweight women during pregnancy
      and the postpartum period and to develop appropriate and feasible implementation strategies
      to support nurses to deliver interventions in maternity clinics.

      The aim of this study is to evaluate the effectiveness of the Supporting Lifestyle Change in
      Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM) intervention. Secondary aim
      is to evaluate the implementation of SLIM intervention in maternity care.

      Intervention was developed based on findings of overweight women and their care givers
      interview study. In addition, intervention was planned in collaboration with public health
      nurses working in maternity clinics in workshops. The intervention targeting overweight
      pregnant women to improve their weight-management will be delivered during routine perinatal
      visits from the first visit to three months after child birth. Interventions core components
      will be goalsetting, motivational interviewing, feedback and health technology. Health
      technology includes Oura-ring and ZotCare -application. ZotCare -application combines data
      from Oura Smart Ring, electronic food diary and it´s also platform for researchers to send
      e.g. questionnaires and surveys to participants. Oura-smartring is an advanced technology
      ring that monitors e.g. heart rate, heart rate variability (HRV), steps, body temperature and
      sleep) and a smartphone application that includes data from Oura, and electronic food diary.
      Data collected with Oura -smartrings will be transmitted to cloud servers via a smartphone.
      The cloud will be responsible for storing the data and for performing the data preprocessing
      and analysis methods. Interventions primary outcome will be self-efficacy. Secondary outcomes
      will be womens weight, depression symptoms, quality of life and sence of coherence.

      Data will be collected via Oura smartring, electronic food diary and validated measures:
      Weight Efficacy Life-Style Questionnaire (WEL), Self-Efficacy for Physical Activity Scale
      (PASE), six-factor questionnaire (6-FQ), Three Factor Eating Questionnaire (TFEQ-R18),
      WHOQOL-BREF, Sense of coherence (SOC-13), Pregnancy anxiety (PRAQ-R2), Perceived stress and
      Edinburgh Postnatal Depression scale (EPDS). Intervention implementation will be evaluated
      with process evaluation. Interventions acceptability, appropriateness and feasibility will be
      assessed with validated measures: Acceptability of Intervention Measure (AIM), Intervention
      Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Data will be
      collected from public health nurses working in maternity clinics using focus group interviews
      and workshops.
    

Intervention name(s): SLIM intervention
Intervention type(s): Behavioral
Intervention description(s): Core components: 1) goal setting, 2) motivational interviewing, 3) feedback, 4) health technology
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pregnancy; Overweight; Obesity; Wearable Electronic Devices; Technology; Internet-Based Intervention