- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Altındağ
-
Ankara, Altındağ, Turecko (Türkiye)
- Ankara Medipol University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Body weight (kg)
Časové okno: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
Body weight measured using a calibrated digital scale
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Body mass index (kg/m²)
Časové okno: 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)
Časové okno: 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.
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Waist circumference (cm)
Časové okno: 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.
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Hip circumference (cm)
Časové okno: 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
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
Neck circumference (cm)
Časové okno: 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.
|
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
|
|
waist-to-height ratio
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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(%)
Časové okno: 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 (%)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
perceived stress level
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Elif Dadak Yıldırım, PhD(c), Ankara Medipol University
- Vrchní vyšetřovatel: İlknur G Yıldırım, Asst. Prof., Ankara Medipol University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AMU-EC143-2026
- EC-2026-143 (Jiný identifikátor: Ankara Medipol University Ethics Committee)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .