Clinical trial NCT06225518: The Effect of a Machine Learning-Based Mobile Application on Physical Activity in Overweight and Obese Women
Official title: The Effect of a Machine Learning-Based Mobile Application on Physical Activity in Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research was planned as an experimental type study. Randomization will be achieved by randomly selecting women from the study population and randomly assigning from the sample group women to the experimental and control groups by two people other than the researcher. Supervision in the research will be provided by creating a control group. Management will be provided by evaluating and comparing the effect of the mobile application on the physical activity level of women in experimental and control groups.
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate the effect of an algorithm-driven mobile application that provides personalized recommendations for increasing physical activity, which is an important health behavior, in the prevention of obesity and many other related non-communicable diseases in overweight and obese women. Hypotheses of this study are:

* The physical activity level of overweight and obese adult women in the intervention group increases.
* Body Mass Index decreases in overweight and obese adult women in the intervention group.
* The daily step count of overweight and obese adult women in the intervention group increases.

Participants will be asked to use the mobile application they received daily and follow their personalized physical activity program.

Researchers will compare the experimental and control groups to see if the mobile application affected the physical activity level.

Detailed description: According to the World Health Organization (WHO), physical inactivity is one of the significant public health issues of our time. Health problems associated with this issue lead to an overload of healthcare services. According to the report published by WHO in 2022, the prevalence of overweight and obesity in the world constitutes 60% of the total population and causes 1.2 million deaths in the European region. In Turkey, the prevalence of obesity is 66.8 in all genders and 69.3 in women. The increasing epidemic of excessive weight and obesity, which leads to chronic diseases in the long term, poses a significant public health threat both globally and in our country.

Physical activity is an essential lifestyle measure for maintaining a healthy weight and preventing obesity. In women, physical activity levels decrease during pregnancy, and inactivity continues after childbirth. Therefore, determining the physical activity levels of women at risk for obesity and planning public health initiatives to increase their physical activity levels are also important.

Cognitive Behavioral Theory (CBT) is a theory that suggests thoughts, feelings, and behaviors are interconnected and influence each other. CBT is used in many health improvement interventions, such as improving physical activity levels. On the other hand, Social Cognitive Theory (SCT) is an important theory in planning behavior change interventions related to individuals' changing and sustaining health behaviors. SCT provides a strong perspective in understanding health behaviors related to physical activity by identifying the interaction between individuals, the environment, and behavior. Associating the components of CBT and SCT with the level of physical activity will provide a comprehensive approach by simultaneously addressing cognitive, behavioral, environmental, and social factors that affect the physical activity levels of middle-aged women.

Increasing physical activity is an effective intervention in reducing the prevalence of obesity and overweight, which are significant public health problems worldwide and in our country. There is an urgent need for behavior change interventions to determine and increase physical activity levels in the entire society and especially in risk groups to promote healthy lifestyles. This research is designed to evaluate the impact of a machine learning-based mobile application that provides personalized recommendations to increase physical activity, which is an essential health behavior in preventing obesity and many other non-communicable diseases in overweight and obese women.

After obtaining institutional and ethical approvals, data will be collected through face-to-face interviews with women aged 35-60 who apply to Family Health Centers in Istanbul. The height and weight of the women will be measured, and their Body Mass Index (BMI) will be calculated. Women with a BMI value of 25 or higher and no medical condition or health issue that would impede their physical activity status will be included in the study.

The data for the study will be collected using the following tools and measures: Identifying Characteristics Form, Visual Analog Scale (VAS), Anthropometric Measurements, International Physical Activity Questionnaire (Short Form), Women's Physical Activity Self-Efficacy Scale, Physical Activity Barriers Scale, Cognitive Behavioral Physical Activity Scale, Exercise Self-Efficacy Scale, and a smart wristband.

After data collection, the data will be transferred to the Statistical Package for the Social Sciences (SPSS) 25.0 software package for analysis. The data analysis will include percentages, mean values, standard deviations and chi-square test, independent sample t-test, repeated measures ANOVA test, and the corrected Bonferroni test for advanced analyses.

Eligibility criteria: Inclusion Criteria:

* BMI\>25
* Who do not have any obstacle to participating in physical activities

Exclusion Criteria:

* Who have previously used a smart band to increase their physical activity levels

Primary outcomes:
measure: International Physical Activity Questionnaire (IPAQ) score
timeFrame: 3 months
measure: Daily step count
timeFrame: 3 months
measure: BMI
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpasa (IUC)
Study officials:
References:
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