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

NCT07778550 | Completed

• 1 other identifier: 51
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight

Keywords

Electrical Muscle Stimulation; diet; weight loss; appetite

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  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.

  Baseline and 6 weeks

Secondary Outcomes (4)

• Change in Body Mass Index (BMI)

  Baseline and 6 weeks

• Change in Body Fat Percentage

  Baseline and 6 weeks

• Change in Fat Mass

  Baseline and 6 weeks

• Change in Fat-Free Mass

  Baseline and 6 weeks

Other Outcomes (18)

• Change in Fasting Blood Glucose

  Baseline and 6 weeks

• Change in Glycated Hemoglobin (HbA1c)

  Baseline and 6 weeks

• Change in Fasting Insulin

  Baseline and 6 weeks

Study Arms (3)

Diet

ACTIVE COMPARATOR

Participants received an individualized energy-restricted diet program with an energy deficit of approximately 500 kcal/day for 6 weeks.

Behavioral: Individualized Energy-Restricted Diet

Diet + Exercise

EXPERIMENTAL

Participants received the individualized energy-restricted diet program and were instructed to perform at least 30 minutes of moderate-intensity walking daily throughout the 6-week intervention period.

Behavioral: Individualized Energy-Restricted Diet; Behavioral: Moderate-Intensity Walking

Diet + Electrical Muscle Stimulation

EXPERIMENTAL

Participants received the individualized energy-restricted diet program in addition to localized abdominal electrical muscle stimulation (EMS). EMS was administered twice weekly on non-consecutive days for 6 weeks, for a total of 12 sessions, with each session lasting approximately 25 minutes.

Behavioral: Individualized Energy-Restricted Diet; Device: Electrical Muscle Stimulation (EMS)

Interventions

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.

Diet; Diet + Electrical Muscle Stimulation; Diet + Exercise

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.

Diet + Exercise

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.

Diet + Electrical Muscle Stimulation

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Feray ÇAĞIRAN YILMAZ

Kayapınar, Diyarbakır, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants were randomly assigned in parallel to one of three intervention arms: Diet, Diet plus Exercise, or Diet plus Electrical Muscle Stimulation (EMS), with 25 participants in each arm.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 21, 2026
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)