Obesity & OverweightNCT07778550
Effects of Diet, Exercise, and Electrical Muscle Stimulation in Overweight and Obese Women
A study testing Individualized Energy-Restricted Diet, Moderate-Intensity Walking and Electrical Muscle Stimulation (EMS) in people with Obesity & Overweight, run by Dicle University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Individualized Energy-Restricted Diet, Moderate-Intensity Walking and Electrical Muscle Stimulation (EMS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 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 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Diet, Exercise, and Electrical Muscle Stimulation on Anthropometric, Biochemical, and Appetite Outcomes 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.
Read the detailed description
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.
- Conditions
- Obesity & Overweight
- Being tested
- Individualized Energy-Restricted Diet, Moderate-Intensity Walking, Electrical Muscle Stimulation (EMS)
- Keywords
- Electrical Muscle Stimulation, diet, weight loss, appetite
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Energy-Restricted DietBehavioural
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 WalkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet | Active comparator | Participants received an individualized energy-restricted diet program with an energy deficit of approximately 500 kcal/day for 6 weeks. Receives: 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. Receives: 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. Receives: Behavioral: Individualized Energy-Restricted Diet; Device: Electrical Muscle Stimulation (EMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (4)
Change in Body Mass Index (BMI)
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.
Measured: Baseline and 6 weeks
Change in Body Fat Percentage
Body fat percentage was assessed using bioelectrical impedance analysis (InBody 270) at baseline and after the 6-week intervention.
Measured: Baseline and 6 weeks
Change in Fat Mass
Fat mass was assessed using bioelectrical impedance analysis (InBody 270) at baseline and after the 6-week intervention.
Measured: Baseline and 6 weeks
Change in Fat-Free Mass
Fat-free mass was assessed using bioelectrical impedance analysis (InBody 270) at baseline and after the 6-week intervention.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Mar 2026
- 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 Obesity & OverweightStudies 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
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feray ÇAĞIRAN YILMAZ, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778550
- Sponsor's protocol ID
- 51
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Diet, Exercise, and Electrical Muscle Stimulation on Anthropometric, Biochemical, and Appetite Outcomes in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT07778550
- Acronym / sponsor ID
- 51
- Conditions
- Obesity & Overweight
- Keywords
- Electrical Muscle Stimulation, diet, weight loss, appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 21 Aug 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diet | Active comparator | Behavioral: Individualized Energy-Restricted DietParticipants received an individualized energy-restricted diet program with an energy deficit of approximately 500 kcal/day for 6 weeks. |
| Diet + Exercise | Experimental | Behavioral: Individualized Energy-Restricted Diet, Behavioral: Moderate-Intensity WalkingParticipants 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. |
| Diet + Electrical Muscle Stimulation | Experimental | Behavioral: Individualized Energy-Restricted Diet, Device: Electrical Muscle Stimulation (EMS)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. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- History of thrombosis or active thrombotic risk
- Diagnosed hypertension
- Pregnancy or lactation
- Epilepsy
- History of abdominal, gastric, or inguinal hernia
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 |
|---|---|---|
| Individualized Energy-Restricted DietParticipants 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. | Behavioural | Diet, Diet + Electrical Muscle Stimulation, Diet + Exercise |
| Moderate-Intensity WalkingParticipants 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. | Behavioural | Diet + Exercise |
| Electrical Muscle Stimulation (EMS)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. | Device | Diet + Electrical Muscle Stimulation |
Primary outcome
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.
4 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline and 6 weeks
Change in Body Fat Percentage
Time frame: Baseline and 6 weeks
Change in Fat Mass
Time frame: Baseline and 6 weeks
Change in Fat-Free Mass
Time frame: Baseline and 6 weeks
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 21 Aug 2026.
- Individual participant dataSharing planned: Yes. upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Energy-Restricted Diet, Moderate-Intensity Walking and Electrical Muscle Stimulation (EMS) in people with Obesity & Overweight, run by Dicle 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 7 inclusion and 13 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 21 Aug 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?
Change in Body Weight (time frame: Baseline and 6 weeks). 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 21 Aug 2026.