Weight CyclingNCT07582952
Effect of Meal Frequency on Diet Self-Efficacy and Perceived Stress in Women With Weight Cycling
A study testing 3-meal diet plan and A dietary intervention comprising 3 main meals and 3 snacks in people with Weight Cycling and Obesity & Overweight, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Weight Cycling, Obesity & Overweight, Dietary Self-efficiacy
- What is being tested?
- 3-meal diet plan and A dietary intervention comprising 3 main meals and 3 snacks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
The study was conducted on women aged 25-55 who voluntarily applied to a dietary counseling office, met the inclusion criteria, had a BMI between 25 and 35 kg/m², and experienced weight fluctuations. In the analysis conducted to determine the sample size, the effect size was f = 0.204, the Type I error level was α = 0.05, the test power (1-β) was 0.95, and measurements were taken at 6 time points (0, 2, 4, 6, 8 Weeks and 6 months after the intervention ended), inter-measurement correlation r = 0.50, and the non-sphericity correction ε = 1. Under these conditions, the required total sample size was determined to be 41; considering the anticipated 20% participant attrition during the study, it was determined that at least 49 participants were needed, and to obtain more accurate data, it was planned to include at least 52 participants; the study was completed with a total of 59 participants. The intervention phase of the study lasted 8 weeks for each participant. During the intervention period, face-to-face interviews were conducted every 2 weeks, and all measurements within the scope of the study were repeated. Following the completion of the 8-week intervention, no further intervention or follow-up was conducted, and participants' ability to maintain their weight loss was assessed via a single follow-up measurement 6 months later. In accordance with the recommendations, a weight-loss diet was planned and implemented for each participant, reducing daily energy intake by 500-700 kcal to facilitate a weight loss of 0.5-1.0 kg per week; A weight-loss diet appropriate for the women's age and energy and nutrient requirements was planned, and two groups were formed using a simple randomization method. Group 1 followed a meal plan consisting of 3 main meals, while Group 2 followed a meal plan consisting of 3 main meals and 3 snacks. Written and verbal informed consent was obtained from all participants via the "Informed Consent Form." At the beginning of our study, a general information form, a three-day food consumption record, the International Physical Activity Questionnaire Short Form (IPAQ SHORT FORM), the Perceived Stress Scale (PSS), the Dietary Self-Efficacy Scale (DESS), and the General Well-Being Scale Short Form (GWBS-SF) were used. At the 8th week, when the intervention ended, and at the 6-month follow-up, the Perceived Stress Scale (PSS), Dietary Self-Efficacy Scale (DESS), and General Well-Being Scale Short Form (GWBS-SF) were repeated. Anthropometric measurements and body composition analyses conducted as part of the study (body weight, height, BMI, waist-to-height ratio, waist circumference, hip circumference, neck circumference, waist-to-height ratio waist-to-hip ratio, total body fat (kg and %), lean body mass (kg and %), body water (L ), basal metabolic rate (kcal)) were performed at weeks 0, 2, 4, 6, and 8, as well as 6 months after the intervention ended. Anthropometric measurements were taken using standard measurement techniques, while body composition analyses were performed using the INBODY 270 device. Anthropometric indices (Lipid Accumulation Product Index - LAP, Visceral Adiposity Index - VAI, Conicity Index - CI, Body Shape Index - ABSI, Abdominal Volume Index - AVI, Body Adiposity Index - BAI, Body Roundness Index - BRI, Anthropometric Risk Index - ARI) calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters. Participants' biochemical test results were used to develop individualized dietary plans and to observe changes in biochemical findings during the weight loss process. No new blood tests were requested from the participants in this study. The biochemical data used in the study (fasting blood glucose, triglycerides, total cholesterol, HDL-C, LDL-C, TSH, ALT, AST, HbA1c) were obtained from laboratory results recorded in the participants' health records and dating back to the past 3 months. Note: This trial was retrospectively registered. Data collection was completed prior to registration in ClinicalTrials.gov.
- Conditions
- Weight Cycling, Obesity & Overweight, Dietary Self-efficiacy, Perceived Stress, Meal Frequency
- Being tested
- 3-meal diet plan, A dietary intervention comprising 3 main meals and 3 snacks
- Keywords
- Meal Frequency, Dietary Intervention, Weight Management, weight cycle
- Medical subject headings
- Weight Cycling, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-meal diet planBehavioural
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.
A dietary intervention comprising 3 main meals and 3 snacksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 Meal Group | Active comparator | Participants followed a weight-loss diet consisting of 3 main meals per day. Receives: Behavioral: 3-meal diet plan |
| 6 Meal Group | Experimental | Participants followed a weight-loss diet consisting of 3 main meals and 3 snacks per day. Receives: Behavioral: A dietary intervention comprising 3 main meals and 3 snacks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Body weight measured using a calibrated digital scale
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Body mass index (kg/m²)
Calculated as body weight in kilograms divided by height in metres squared
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Height (cm)
Height measured using a stadiometer with participants standing upright, feet together, in Frankfurt plane position.
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Waist circumference (cm)
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.
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Hip circumference (cm)
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
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Neck circumference (cm)
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.
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
waist-to-height ratio
Waist-to-height ratio calculated by dividing waist circumference (cm) by height (cm).
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
waist-to-hip ratio
Waist-to-hip ratio calculated by dividing waist circumference (cm) by hip circumference (cm).
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
basal metabolic rate (kcal)
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Body Fat mass (kg)
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Lean body mass (kg)
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Percentage of lean body mass(%)
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Body fat percentage (%)
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Total body water (L)
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Measured: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Lipid accumulation product index-LAP
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference(cm) and triglycerides (mmol/L))
Measured: Baseline, Week 8 and 6 months post-intervention
Visceral adiposity index-VAI
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)).
Measured: Baseline, Week 8 and 6 months post-intervention
Conicity index - CI
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (m),Body weight (kg), Height (m) )
Measured: Baseline, Week 8 and 6 months post-intervention
A body shape index-ABSI
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (m), BMI(kg/m²) and heigh(m))
Measured: Baseline, Week 8 and 6 months post-intervention
Abdominal volume index-AVI
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (cm), hip circumference (cm)).
Measured: Baseline, Week 8 and 6 months post-intervention
Body adiposity index-BAI
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (Hip circumference (cm), Height (m)).
Measured: Baseline, Week 8 and 6 months post-intervention
Body roundness index-BRI
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (Waist circumference (m), Height (m)).
Measured: Baseline, Week 8 and 6 months post-intervention
Anthropometric risk index-ARI
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.
Measured: Baseline, Week 8 and 6 months post-intervention
Fasting blood glucose (mg/dL)
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.
Measured: Baseline, Week 8 and 6 months post-intervention
Triglycerides (mg/dL)
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.
Measured: Baseline, Week 8 and 6 months post-intervention
Total cholesterol (mg/dL)
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.
Measured: Baseline, Week 8 and 6 months post-intervention
HDL cholesterol (mg/dL)
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.
Measured: Baseline, Week 8 and 6 months post-intervention
LDL cholesterol (mg/dL)
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.
Measured: Baseline, Week 8 and 6 months post-intervention
Thyroid stimulating hormone (TSH) (µIU/mL)
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.
Measured: Baseline, Week 8 and 6 months post-intervention
Alanine aminotransferase (ALT) (U/L)
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.
Measured: Baseline, Week 8 and 6 months post-intervention
Aspartate aminotransferase (AST) (U/L)
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.
Measured: Baseline, Week 8 and 6 months post-intervention
Secondary outcomes (3)
perceived stress level
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.
Measured: Baseline, Week 8 and 6 months post-intervention
dietary self-efficacy
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.
Measured: Baseline, Week 8 and 6 months post-intervention
General Well-Being
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.
Measured: Baseline, Week 8 and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start4 Aug 2025
- Primary completion1 Oct 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight CyclingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention phase of the study lasted 8 weeks. During the intervention period, face-to-face interviews were conducted every 2 weeks, and measurements were repeated. After the intervention was completed, the ability to maintain weight loss was assessed through a single measurement taken 6 months later. Two groups were formed using a simple randomization method (Group 1: 3 main meals; Group 2: 3 main meals + 3 snacks). In accordance with the recommendations, a weight loss program was implemented for each participant. Anthropometric measurements and body composition analyses were performed at weeks 0, 2, 4, 6, and 8, and 6 months after the intervention ended. While anthropometric measurements were performed using standard measurement techniques, body composition analyses were conducted using the INBODY 270 device. The biochemical data used in the study were obtained from laboratory results from the participants' health records covering the previous 3 months.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Gökçe YILDIRIM=, Ankara Medipol University
- Investigators
- Elif Dadak Yıldırım, PhD(c), Study director, Ankara Medipol Universityİlknur G Yıldırım, Asst. Prof., Principal investigator, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582952
- Sponsor's protocol ID
- AMU-EC143-2026
- Other IDs
- EC-2026-143
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality. All data were collected under informed consent with assurances of anonymity
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07582952
- Acronym / sponsor ID
- AMU-EC143-2026
- Conditions
- Weight Cycling, Obesity & Overweight, Dietary Self-efficiacy, Perceived Stress, Meal Frequency
- Keywords
- Meal Frequency, Dietary Intervention, Weight Management, weight cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was conducted on women aged 25-55 who voluntarily applied to a dietary counseling office, met the inclusion criteria, had a BMI between 25 and 35 kg/m², and experienced weight fluctuations. In the analysis conducted to determine the sample size, the effect size was f = 0.204, the Type I error level was α = 0.05, the test power (1-β) was 0.95, and measurements were taken at 6 time points (0, 2, 4, 6, 8 Weeks and 6 months after the intervention ended), inter-measurement correlation r = 0.50, and the non-sphericity correction ε = 1. Under these conditions, the required total sample size was determined to be 41; considering the anticipated 20% participant attrition during the study, it was determined that at least 49 participants were needed, and to obtain more accurate data, it was planned to include at least 52 participants; the study was completed with a total of 59 participants. The intervention phase of the study lasted 8 weeks for each participant. During the intervention period, face-to-face interviews were conducted every 2 weeks, and all measurements within the scope of the study were repeated. Following the completion of the 8-week intervention, no further intervention or follow-up was conducted, and participants' ability to maintain their weight loss was assessed via a single follow-up measurement 6 months later. In accordance with the recommendations, a weight-loss diet was planned and implemented for each participant, reducing daily energy intake by 500-700 kcal to facilitate a weight loss of 0.5-1.0 kg per week; A weight-loss diet appropriate for the women's age and energy and nutrient requirements was planned, and two groups were formed using a simple randomization method. Group 1 followed a meal plan consisting of 3 main meals, while Group 2 followed a meal plan consisting of 3 main meals and 3 snacks. Written and verbal informed consent was obtained from all participants via the "Informed Consent Form." At the beginning of our study, a general information form, a three-day food consumption record, the International Physical Activity Questionnaire Short Form (IPAQ SHORT FORM), the Perceived Stress Scale (PSS), the Dietary Self-Efficacy Scale (DESS), and the General Well-Being Scale Short Form (GWBS-SF) were used. At the 8th week, when the intervention ended, and at the 6-month follow-up, the Perceived Stress Scale (PSS), Dietary Self-Efficacy Scale (DESS), and General Well-Being Scale Short Form (GWBS-SF) were repeated. Anthropometric measurements and body composition analyses conducted as part of the study (body weight, height, BMI, waist-to-height ratio, waist circumference, hip circumference, neck circumference, waist-to-height ratio waist-to-hip ratio, total body fat (kg and %), lean body mass (kg and %), body water (L ), basal metabolic rate (kcal)) were performed at weeks 0, 2, 4, 6, and 8, as well as 6 months after the intervention ended. Anthropometric measurements were taken using standard measurement techniques, while body composition analyses were performed using the INBODY 270 device. Anthropometric indices (Lipid Accumulation Product Index - LAP, Visceral Adiposity Index - VAI, Conicity Index - CI, Body Shape Index - ABSI, Abdominal Volume Index - AVI, Body Adiposity Index - BAI, Body Roundness Index - BRI, Anthropometric Risk Index - ARI) calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters. Participants' biochemical test results were used to develop individualized dietary plans and to observe changes in biochemical findings during the weight loss process. No new blood tests were requested from the participants in this study. The biochemical data used in the study (fasting blood glucose, triglycerides, total cholesterol, HDL-C, LDL-C, TSH, ALT, AST, HbA1c) were obtained from laboratory results recorded in the participants' health records and dating back to the past 3 months. Note: This trial was retrospectively registered. Data collection was completed prior to registration in ClinicalTrials.gov.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention phase of the study lasted 8 weeks. During the intervention period, face-to-face interviews were conducted every 2 weeks, and measurements were repeated. After the intervention was completed, the ability to maintain weight loss was assessed through a single measurement taken 6 months later. Two groups were formed using a simple randomization method (Group 1: 3 main meals; Group 2: 3 main meals + 3 snacks). In accordance with the recommendations, a weight loss program was implemented for each participant. Anthropometric measurements and body composition analyses were performed at weeks 0, 2, 4, 6, and 8, and 6 months after the intervention ended. While anthropometric measurements were performed using standard measurement techniques, body composition analyses were conducted using the INBODY 270 device. The biochemical data used in the study were obtained from laboratory results from the participants' health records covering the previous 3 months.
| Arm | Type | Receives |
|---|---|---|
| 3 Meal Group | Active comparator | Behavioral: 3-meal diet planParticipants followed a weight-loss diet consisting of 3 main meals per day. |
| 6 Meal Group | Experimental | Behavioral: A dietary intervention comprising 3 main meals and 3 snacksParticipants followed a weight-loss diet consisting of 3 main meals and 3 snacks per day. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Presence of cardiovascular disease
- Chronic kidney disease
- Hypertension
- Diagnosis of Type 1 or Type 2 diabetes mellitus
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-meal diet planA 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. | Behavioural | 3 Meal Group |
| A dietary intervention comprising 3 main meals and 3 snacksA 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. | Behavioural | 6 Meal Group |
Primary outcome
Body weight (kg)
Time frame: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Body weight measured using a calibrated digital scale
Body mass index (kg/m²)
Time frame: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Calculated as body weight in kilograms divided by height in metres squared
Height (cm)
Time frame: 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.
Waist circumference (cm)
Time frame: 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.
Hip circumference (cm)
Time frame: 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
Neck circumference (cm)
Time frame: 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.
waist-to-height ratio
Time frame: 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).
waist-to-hip ratio
Time frame: 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).
basal metabolic rate (kcal)
Time frame: 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.
Body Fat mass (kg)
Time frame: 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.
Lean body mass (kg)
Time frame: 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.
Percentage of lean body mass(%)
Time frame: 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.
Body fat percentage (%)
Time frame: 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.
Total body water (L)
Time frame: 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.
Lipid accumulation product index-LAP
Time frame: 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))
Visceral adiposity index-VAI
Time frame: 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)).
Conicity index - CI
Time frame: 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) )
A body shape index-ABSI
Time frame: 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))
Abdominal volume index-AVI
Time frame: 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)).
Body adiposity index-BAI
Time frame: 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)).
Body roundness index-BRI
Time frame: 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)).
Anthropometric risk index-ARI
Time frame: 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.
Fasting blood glucose (mg/dL)
Time frame: 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.
Triglycerides (mg/dL)
Time frame: 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.
Total cholesterol (mg/dL)
Time frame: 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.
HDL cholesterol (mg/dL)
Time frame: 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.
LDL cholesterol (mg/dL)
Time frame: 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.
Thyroid stimulating hormone (TSH) (µIU/mL)
Time frame: 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.
Alanine aminotransferase (ALT) (U/L)
Time frame: 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.
Aspartate aminotransferase (AST) (U/L)
Time frame: 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.
3 secondary outcomes
perceived stress level
Time frame: Baseline, Week 8 and 6 months post-intervention
dietary self-efficacy
Time frame: Baseline, Week 8 and 6 months post-intervention
General Well-Being
Time frame: Baseline, Week 8 and 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality. All data were collected under informed consent with assurances of anonymity
Related trials for Weight Cycling
Active, not recruiting
E-Bike Commuting and Health in Overweight College Students
Obesity &Amp; Overweight, Sedentary Behaviors
Recruiting
Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
Polycystic Ovary Syndrome
Active, not recruitingObservational study
An Observational Cohort Study to Obese Patients With Weight Cycling
Weight Cycling, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Dadak Yıldırım, PhD(c) study director
Ankara Medipol University
İlknur G Yıldırım, Asst. Prof. principal investigator
Ankara Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-meal diet plan and A dietary intervention comprising 3 main meals and 3 snacks in people with Weight Cycling and Obesity & Overweight, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kg) (time frame: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.