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

Overweight or Obesity Clinical Trial

— SLIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04826861
• Other study ID #: SLIM
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: September 2023
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity
• Pregnancy-Related Condition, Unspecified

Intervention

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

Locations

Country	Name	City	State
Finland	Maternity care unit	Loimaa

Sponsors (3)

Lead Sponsor	Collaborator
University of Turku	Helsinki University Central Hospital, University of California, Irvine

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of eating self-efficacy of overweight women	Validated 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 from first trimester Self-efficacy at third trimester and further at two months after delivery
Primary	Change of physical activity self-efficacy of overweight women	Validated 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.	Change from first trimester Self-efficacy at third trimester and further at two months after delivery
Secondary	Weight during pregnancy and after delivery	Measurement: Womens weight (patient records)	Through study completion, an average of 11 to 12 months.
Secondary	Change of depression symptoms of overweight women	Validated 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.	From first trimester depression symptoms at third trimester and further at two months after delivery
Secondary	Change of overweight womens quality of life	Validated 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 from first trimester quality of life at third trimester and further at two months after delivery
Secondary	Change of overweight womens sense of coherence	Validated 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 from first trimester sence of coherence at third trimester and further at two months after delivery
Secondary	Change of pregnancy anxiety.	Validated 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 from first trimester anxiety at third trimester and further at two months after delivery
Secondary	Change of perceived stress	Validated 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.	Change from first trimester perceived stress at third trimester and further at two months after delivery
Secondary	Interventions acceptability, appropriateness and feasibility	Validated 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.	At gestational week 20, 34 and three months after delivery