- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07582952
Effect of Meal Frequency on Diet Self-Efficacy and Perceived Stress in Women With Weight Cycling
Effect of a Diet Intervention With Different Meal Frequencies on Diet Self-Efficacy and Perceived Stress in Women With Weight Cycling: A Randomized Controlled Trial
The World Health Organization (WHO) defines obesity as abnormal or excessive fat accumulation in the body that may adversely affect health. In 2022, 1 in 8 people worldwide lived with obesity, while the adult obesity rate has more than doubled since 1990, and the adolescent obesity rate has quadrupled.
Obesity is a risk factor for noncommunicable diseases such as type 2 diabetes, hypertension, cardiovascular diseases, cancer, and sleep apnea, and is associated with an increased risk of death. The treatment of obesity-related comorbidities, along with indirect costs resulting from lost productivity and premature death, contributes to the economic burden caused by obesity. Therefore, effective management of obesity is of critical importance for improving overall health outcomes and reducing the burden on healthcare systems. It has been demonstrated that a 5% reduction in body weight in individuals diagnosed with obesity can improve health outcomes, and this value has been established as a target standard for weight loss interventions. However, while dietary interventions can achieve clinically meaningful weight loss, weight regain is common due to a combination of low adherence to dietary strategies and compensatory physiological mechanisms that influence weight regain. Consequently, individuals may find themselves in a "weight cycle," losing weight and then regaining it. Weight maintenance is defined as intentional weight loss followed by the preservation of that loss for at least six months. It has been noted that the weight cycle complicates this process.
The weight cycle defined as repeated periods of intentional weight loss followed by regain is considered a common yet poorly understood factor among obese individuals. The weight cycle is viewed as one of the major challenges in clinical obesity care. For this reason, it is emphasized that strategies aimed at preventing weight cycling or promoting weight maintenance have gained importance. Additionally, attention is drawn to psychological factors in eating behavior, with particular emphasis on the individual's self-confidence and stress levels being crucial for sustaining healthy eating behaviors.
Individuals experiencing weight cycling often face challenges with diet adherence, sustainability, and stress management. Meal frequency strategies applied to these individuals can influence not only weight loss but also diet adherence and the psychological experience of the dietary process. Given the rise in obesity and obesity-related disorders, understanding the relationship between stress, self-efficacy, and food choice in young adulthood may offer insights into preventing adverse health outcomes in later life stemming from poor dietary habits. An appropriate meal schedule can help an individual adapt better to the diet and manage the process with less stress; thereby facilitating weight maintenance success and making healthy eating a lifestyle. However, in the treatment of obesity, data regarding different meal frequency approaches in dietary interventions remain controversial.
The aim of this study is to examine the factors influencing the sustainability of the diet and the long-term maintenance of weight loss in individuals experiencing weight cycling. In this context, the effects of different meal frequencies on this process were evaluated; the study addressed not only physical outcomes but also psychological factors such as how individuals felt during the dietary process, their stress levels, and their self-confidence. Thus, the aim was to present a more comprehensive perspective by examining the relationship between meal frequency and weight management from both physiological and psychological dimensions.
Обзор исследования
Статус
Условия
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Altındağ
-
Ankara, Altındağ, Турция (Туркие)
- Ankara Medipol University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Female participants aged 25-55 years
- Body mass index (BMI) between 25 and 35 kg/m²
- having a history of weight fluctuations
- Willingness to participate and provide informed consent
Exclusion Criteria:
- Presence of cardiovascular disease
- Chronic kidney disease
- Hypertension
- Diagnosis of Type 1 or Type 2 diabetes mellitus
- Pregnancy or breastfeeding
- Use of any medication or dietary supplement for weight loss or fat reduction
- Engagement in intense physical activity
- No having a history of weight fluctuations
- Menopausal status
- Failure to attend scheduled follow-up visits
- Non-adherence to the intervention protocol for three consecutive days
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 3 Meal Group
Participants followed a weight-loss diet consisting of 3 main meals per day.
|
A personalised weight-loss diet that reduces daily calorie intake by 500-700 kcal.
Group 1 followed the diet for 8 weeks, consisting of 3 main meals a day.
|
|
Экспериментальный: 6 Meal Group
Participants followed a weight-loss diet consisting of 3 main meals and 3 snacks per day.
|
A personalised weight-loss diet that reduces daily calorie intake by 500-700 kcal.
Group 1 followed the diet for 8 weeks, consisting of 3 main meals and 3 snacks per day.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Body weight (kg)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
Body weight measured using a calibrated digital scale
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Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Body mass index (kg/m²)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
Calculated as body weight in kilograms divided by height in metres squared
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Height (cm)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
Height measured using a stadiometer with participants standing upright, feet together, in Frankfurt plane position.
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Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Waist circumference (cm)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
Waist circumference was measured using a non-stretch tape measure along the midline between the lowest rib and the iliac crest, with the individual standing with their feet together and arms at their sides in a relaxed position.
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Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Hip circumference (cm)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
Hip circumference was measured using a non-stretchable tape measure across the widest part of the hips, with the individual standing upright, feet together and arms at their sides
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Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Neck circumference (cm)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
During neck circumference measurements, participants were positioned upright with their arms at their sides and their feet together.
The measurements were taken by the researcher, who stood opposite the participant, using a non-stretchable tape measure around the neck near the shoulder.
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Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
waist-to-height ratio
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
Waist-to-height ratio calculated by dividing waist circumference (cm) by height (cm).
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
waist-to-hip ratio
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
Waist-to-hip ratio calculated by dividing waist circumference (cm) by hip circumference (cm).
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
basal metabolic rate (kcal)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Body Fat mass (kg)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Lean body mass (kg)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Percentage of lean body mass(%)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Body fat percentage (%)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Total body water (L)
Временное ограничение: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Lipid accumulation product index-LAP
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference(cm) and triglycerides (mmol/L))
|
Baseline, Week 8 and 6 months post-intervention
|
|
Visceral adiposity index-VAI
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (cm), body mass index(kg/m²),HDL-C (mmol/L) and triglycerides (mmol/L)).
|
Baseline, Week 8 and 6 months post-intervention
|
|
Conicity index - CI
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (m),Body weight (kg), Height (m) )
|
Baseline, Week 8 and 6 months post-intervention
|
|
A body shape index-ABSI
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (m), BMI(kg/m²) and heigh(m))
|
Baseline, Week 8 and 6 months post-intervention
|
|
Abdominal volume index-AVI
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (cm), hip circumference (cm)).
|
Baseline, Week 8 and 6 months post-intervention
|
|
Body adiposity index-BAI
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (Hip circumference (cm), Height (m)).
|
Baseline, Week 8 and 6 months post-intervention
|
|
Body roundness index-BRI
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (Waist circumference (m), Height (m)).
|
Baseline, Week 8 and 6 months post-intervention
|
|
Anthropometric risk index-ARI
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Anthropometric Risk Score (ARS) is a composite score calculated by scoring each anthropometric parameter (BMI, waist circumference, waist-to-hip ratio, and waist-to-height ratio) based on established reference cutoff values and summing the individual scores.
|
Baseline, Week 8 and 6 months post-intervention
|
|
Fasting blood glucose (mg/dL)
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
No additional blood samples were collected from participants.
Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
|
Baseline, Week 8 and 6 months post-intervention
|
|
Triglycerides (mg/dL)
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
No additional blood samples were collected from participants.
Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
|
Baseline, Week 8 and 6 months post-intervention
|
|
Total cholesterol (mg/dL)
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
No additional blood samples were collected from participants.
Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
|
Baseline, Week 8 and 6 months post-intervention
|
|
HDL cholesterol (mg/dL)
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
No additional blood samples were collected from participants.
Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
|
Baseline, Week 8 and 6 months post-intervention
|
|
LDL cholesterol (mg/dL)
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
No additional blood samples were collected from participants.
Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
|
Baseline, Week 8 and 6 months post-intervention
|
|
Thyroid stimulating hormone (TSH) (µIU/mL)
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
No additional blood samples were collected from participants.
Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
|
Baseline, Week 8 and 6 months post-intervention
|
|
Alanine aminotransferase (ALT) (U/L)
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
No additional blood samples were collected from participants.
Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
|
Baseline, Week 8 and 6 months post-intervention
|
|
Aspartate aminotransferase (AST) (U/L)
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
No additional blood samples were collected from participants.
Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
|
Baseline, Week 8 and 6 months post-intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
perceived stress level
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Assessed using the Perceived Stress Scale.
Scores on the Perceived Stress Scale-14 range from 0 to 56, with a higher score indicating a greater perception of stress (a worse outcome).
No cut-off point has been established for the scale.
|
Baseline, Week 8 and 6 months post-intervention
|
|
dietary self-efficacy
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Assessed using the Dietary Self-Efficacy Scale.
Scores on the Dietary Self-Efficacy Scale range from 11 to 55, with a higher score indicating greater dietary self-efficacy (a better outcome).
No cut-off point has been established for the scale.
|
Baseline, Week 8 and 6 months post-intervention
|
|
General Well-Being
Временное ограничение: Baseline, Week 8 and 6 months post-intervention
|
Assessed using the General Well-Being Scale Short Form.
Scores on the General Well-being Scale Short Form range from 14 to 70, with a higher score indicating a higher level of well-being (a better outcome).
No cut-off point has been established for the scale.
|
Baseline, Week 8 and 6 months post-intervention
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Elif Dadak Yıldırım, PhD(c), Ankara Medipol University
- Главный следователь: İlknur G Yıldırım, Asst. Prof., Ankara Medipol University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- AMU-EC143-2026
- EC-2026-143 (Другой идентификатор: Ankara Medipol University Ethics Committee)
Планирование данных отдельных участников (IPD)
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