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Completed

NCT Number: NCT07778550

Effects of Diet, Exercise, and Electrical Muscle Stimulation in Overweight and Obese Women

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.

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Key information

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Feray ÇAĞIRAN YILMAZ

Kayapınar, Diyarbakır, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female participants aged 19-45 years
  • Body mass index (BMI) ≥25.0 kg/m²
  • No more than a 5% change in body weight during the previous 3 months
  • Premenopausal
  • Not participating in a regular exercise program
  • Applying to the center for weight management
  • Willing to participate and providing written informed consent

Exclusion criteria

  • History of thrombosis or active thrombotic risk
  • Diagnosed hypertension
  • Pregnancy or lactation
  • Epilepsy
  • History of abdominal, gastric, or inguinal hernia
  • Cardiac pacemaker or other implanted electronic device
  • Metallic prostheses or large implants
  • Bariatric surgery within the previous 6 months
  • Use of pharmacological treatments that could affect weight loss, including GLP-1 receptor agonists or corticosteroids
  • Diabetes mellitus
  • Malignancy
  • Advanced renal or hepatic disease
  • Any medical condition contraindicating EMS application

Treatment and study plan

Individualized Energy-Restricted Diet

Behavioral

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.

Moderate-Intensity Walking

Behavioral

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.

Electrical Muscle Stimulation (EMS)

Device

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.

Primary outcomes

  1. Change in Body Weight

    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.

Secondary outcomes

  1. Change in Body Mass Index (BMI)

    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.

  2. Change in Body Fat Percentage

    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.

  3. Change in Fat Mass

    Time frame: Baseline and 6 weeks

    Fat mass was assessed using bioelectrical impedance analysis (InBody 270) at baseline and after the 6-week intervention.

  4. Change in Fat-Free Mass

    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.

Other outcomes

  1. Change in Fasting Blood Glucose

    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.

  2. Change in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline and 6 weeks

    HbA1c was assessed at baseline and after completion of the 6-week intervention.

  3. Change in Fasting Insulin

    Time frame: Baseline and 6 weeks

    Fasting insulin was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.

  4. Change in HOMA-IR

    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.

  5. Change in Total Cholesterol

    Time frame: Baseline and 6 weeks

    Total cholesterol was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.

  6. Change in LDL Cholesterol (LDL-C)

    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.

  7. Change in HDL Cholesterol (HDL-C)

    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.

  8. Change in Triglycerides

    Time frame: Baseline and 6 weeks

    Triglyceride levels were assessed using fasting blood samples at baseline and after completion of the 6-week intervention.

  9. Change in Aspartate Aminotransferase (AST)

    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.

  10. Change in Alanine Aminotransferase (ALT)

    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.

  11. Change in C-Reactive Protein (CRP)

    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.

  12. Change in Blood Urea Nitrogen (BUN)

    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.

  13. Change in Serum Creatinine

    Time frame: Baseline and 6 weeks

    Serum creatinine was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.

  14. Change in Serum Iron

    Time frame: Baseline and 6 weeks

    Serum iron was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.

  15. Change in Vitamin B12

    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.

  16. Change in 25-Hydroxyvitamin D [25(OH)D]

    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.

  17. Change in Thyroid-Stimulating Hormone (TSH)

    Time frame: Baseline and 6 weeks

    TSH was assessed using fasting blood samples at baseline and after completion of the 6-week intervention.

  18. Change in Appetite-Related Visual Analog Scale Scores

    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.

Sponsors and collaborators

Lead sponsor

Dicle University

Other

Registry information

Official study title

Comparative Effects of Diet, Exercise, and Electrical Muscle Stimulation on Anthropometric, Biochemical, and Appetite Outcomes in Overweight and Obese Women

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

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.

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