Feray ÇAĞIRAN YILMAZ
Kayapınar, Diyarbakır, Turkey (Türkiye)
NCT Number: NCT07778550
This randomized controlled study evaluated the effects of diet, exercise, and electrical muscle stimulation (EMS) on body measurements, blood test results, and appetite in women with overweight or obesity.
A total of 75 women aged 19-45 years with a body mass index (BMI) of 25 kg/m² or higher were randomly assigned to one of three groups: diet alone, diet plus exercise, or diet plus EMS. All participants received an individualized energy-restricted diet. Participants in the exercise group also performed at least 30 minutes of moderate-intensity walking daily, while participants in the EMS group received abdominal EMS twice per week for six weeks.
Body measurements, selected biochemical parameters, and appetite-related measures, including hunger, satiety, and desire to eat, were assessed before and after the six-week intervention. The study aimed to determine whether adding exercise or EMS to an individualized energy-restricted diet provides additional benefits for body composition, metabolic health, and appetite regulation in women with overweight or obesity.
Looking for future studies?
Notify Me19 year–45 year
Female
Interventional
Not applicable
Kayapınar, Diyarbakır, Turkey (Türkiye)
This randomized controlled study included 75 women aged 19-45 years with overweight or obesity (BMI ≥25 kg/m²). Eligible participants were randomly assigned to three intervention groups, with 25 participants in each group.
All participants received an individualized energy-restricted dietary program designed to provide an energy deficit of approximately 500 kcal/day. The dietary plans provided approximately 55-60% of total energy from carbohydrates, 12-15% from protein, and 25-30% from fat, with a target dietary fiber intake of 25-30 g/day. Participants attended weekly follow-up visits throughout the intervention.
Participants in the Diet Group received the individualized dietary intervention alone. Participants in the Diet + Exercise Group received the same dietary intervention and were instructed to perform at least 30 minutes of moderate-intensity walking daily throughout the six-week intervention. Participants in the Diet + EMS Group received the dietary intervention together with localized abdominal electrical muscle stimulation. EMS was administered twice weekly on non-consecutive days for six weeks, for a total of 12 sessions. Each EMS session lasted approximately 25 minutes.
Anthropometric assessments included body weight, BMI, waist circumference, hip circumference, neck circumference, mid-upper arm circumference, body fat percentage, fat mass, and fat-free mass. Selected biochemical parameters were assessed using fasting blood samples. Appetite-related outcomes, including hunger, satiety, and desire to eat, were evaluated using a Visual Analog Scale (VAS).
Measurements were obtained at baseline and after completion of the six-week intervention. The primary objective was to compare changes in anthropometric outcomes among the three intervention groups. Additional evaluations examined changes in biochemical parameters and subjective appetite-related outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants received an individualized energy-restricted diet designed to provide an energy deficit of approximately 500 kcal/day. The diet provided 55-60% of total energy from carbohydrates, 12-15% from protein, and 25-30% from fat, with a target fiber intake of 25-30 g/day. Participants attended weekly follow-up visits throughout the 6-week intervention period.
Participants were instructed to perform at least 30 minutes of moderate-intensity walking daily throughout the 6-week intervention period. Walking intensity was defined as producing a slight increase in heart rate and breathing while allowing participants to maintain conversation comfortably.
Localized abdominal electrical muscle stimulation was administered twice weekly on non-consecutive days for 6 weeks, for a total of 12 sessions. Each session lasted approximately 25 minutes. Four surface electrodes were positioned symmetrically on the abdominal region. Stimulation was delivered at 85 Hz with a pulse width of approximately 300-400 μs, and intensity was increased according to individual tolerance to achieve visible and palpable muscle contractions without pain or discomfort.
Time frame: Baseline and 6 weeks
Body weight was measured in kilograms using a bioelectrical impedance analysis device (InBody 270) at baseline and after completion of the intervention. Change in body weight was evaluated by comparing the post-intervention measurement with the baseline measurement.
Time frame: Baseline and 6 weeks
Body mass index (BMI) was calculated as body weight in kilograms divided by height in meters squared (kg/m²) at baseline and after the 6-week intervention.
Time frame: Baseline and 6 weeks
Body fat percentage was assessed using bioelectrical impedance analysis (InBody 270) at baseline and after the 6-week intervention.
Time frame: Baseline and 6 weeks
Fat mass was assessed using bioelectrical impedance analysis (InBody 270) at baseline and after the 6-week intervention.
Time frame: Baseline and 6 weeks
Fat-free mass was assessed using bioelectrical impedance analysis (InBody 270) at baseline and after the 6-week intervention.
Time frame: Baseline and 6 weeks
Fasting blood glucose was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
HbA1c was assessed at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Fasting insulin was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
HOMA-IR was calculated using fasting glucose and fasting insulin values at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Total cholesterol was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
LDL cholesterol (LDL-C) was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
HDL cholesterol (HDL-C) was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Triglyceride levels were assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Aspartate aminotransferase (AST) levels were assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Alanine aminotransferase (ALT) levels were assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
C-reactive protein (CRP) levels were assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Blood urea nitrogen (BUN) levels were assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Serum creatinine was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Serum iron was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Serum vitamin B12 was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Serum 25(OH)D was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
TSH was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.
Time frame: Baseline and 6 weeks
Hunger, satiety, and desire to eat were assessed using a 100-mm Visual Analog Scale (VAS) at baseline and after the 6-week intervention. Higher scores indicated greater intensity of the respective appetite sensation. Changes in hunger, satiety, and desire-to-eat scores were evaluated between baseline and post-intervention measurements.
Dicle University
Other
Comparative Effects of Diet, Exercise, and Electrical Muscle Stimulation on Anthropometric, Biochemical, and Appetite Outcomes in Overweight and Obese Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07655739
Body Weight, Body Weight Changes
Elâzığ, Turkey (Türkiye)
View Trial DetailsNCT07471646
Aerobic Exercise, Body Weight
Ann Arbor, Michigan, United States
View Trial DetailsNCT07389122
Body Weight, Body Weight Changes
Bologna, BO, Italy
View Trial DetailsNCT07463417
Behavior, Blood Glucose Monitoring
New York, United States
View Trial Details