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Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM)

Development and Implementation of Supporting Lifestyle Change in Obese Pregnant Mothers Through Wearable Internet-of-Things (SLIM) Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04826861
Acronym
SLIM
Enrollment
55
Registered
2021-04-01
Start date
2021-04-01
Completion date
2023-05-15
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight or Obesity, Pregnancy-Related Condition, Unspecified

Keywords

Pregnancy, Overweight, Obesity, Wearable Electronic Devices, Technology, Internet-Based Intervention

Brief 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.

Interventions

BEHAVIORALSLIM intervention

Core components: 1) goal setting, 2) motivational interviewing, 3) feedback, 4) health technology

Sponsors

University of California, Irvine
CollaboratorOTHER
Helsinki University Central Hospital
CollaboratorOTHER
University of Turku
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* pregnancy maximum 15 gestational weeks * BMI \>25 * finnish language

Exclusion criteria

* women who don´t have smart device * severe mental illness (such as schizophrenia) * diabetes mellitus type 1 * limitation of motility

Design outcomes

Primary

MeasureTime frameDescription
Change of eating self-efficacy of overweight womenChange from first trimester Self-efficacy at third trimester and further at two months after deliveryValidated measurement tool: Weight Efficacy Life-Style Questionnaire (WEL) The 20-item questionnaire asks participants to rate their confidence in their ability to avoid eating on a 10-point Likert scale, 0 (not confident) to 9 (very confident). Scores range from 0 to 180 with higher scores indicating greater levels of self-efficacy.
Change of physical activity self-efficacy of overweight womenChange from first trimester Self-efficacy at third trimester and further at two months after deliveryValidated measurement tool: Self-Efficacy for Physical Activity Scale (PASE). The 5-item questionnaire asks participants to rate their confidence in their ability to regular physical activity on a 5-point Likert scale, 1 (not confident) to 5 (very confident). Scores range from 5 to 25 with higher scores indicating greater levels of self-efficacy.

Secondary

MeasureTime frameDescription
Weight during pregnancy and after deliveryThrough study completion, an average of 11 to 12 months.Measurement: Womens weight (patient records)
Change of depression symptoms of overweight womenFrom first trimester depression symptoms at third trimester and further at two months after deliveryValidated measurement tool: Perceived stress and Edinburgh Postnatal Depression scale (EPDS). The 10-item questionnaire asks participants to rate their depression symptoms on a 4-point Likert scale. Scores range from 0 to 30 with higher scores indicating greater levels of depression.
Change of overweight womens quality of lifeChange from first trimester quality of life at third trimester and further at two months after deliveryValidated measurement tool: WHO quality of life (WHOQOL-BREF). The 26-item questionnaire asks participants to rate their quality of life on a 5-point Likert scale, 1 to 5. Scores range from 0 to 100 with higher scores indicating better quality of life.
Change of overweight womens sense of coherenceChange from first trimester sence of coherence at third trimester and further at two months after deliveryValidated measurement tool: Sense of coherence (SOC-13). The 13-item questionnaire asks participants to rate their sence of coherence on a 7-point Likert scale, 1 to 7. Higher scores indicate better sence of coherence.
Change of pregnancy anxiety.Change from first trimester anxiety at third trimester and further at two months after deliveryValidated tool: Pregnancy anxiety questionnaire-revised for all pregnant women regardless of parity:(PRAQ-R2) The 10-item questionnaire asks participants to rate their pregnancy anxiety on a 5-point Likert scale, 1 to 5. Higher scores indicate higher pregnancy anxiety.
Change of perceived stressChange from first trimester perceived stress at third trimester and further at two months after deliveryValidated tool: A global measure of perceived stress (original versions). The 10-item questionnaire asks participants to rate their pregnancy anxiety on a 5-point Likert scale, 1 to 5. Higher scores indicate higher perceived stress.
Interventions acceptability, appropriateness and feasibilityAt gestational week 20, 34 and three months after deliveryValidated measures: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM). The 15-item questionnaire asks participants to rate interventions acceptability, appropriateness and feasibility on a 5-point Likert scale, 1 to 5. Higher scores indicate higher acceptability, appropriateness and feasibility.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026