Weight LossOBESITYNCT06685432
The Effect of Motivational Interviewing on Body Weight and Dietary Habits in Young Adult Women: A Randomized Controlled Study
A study testing Diet in people with Weight Loss and Obese Women, run by Sibel ERDEM at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to evaluate the effect of applying web-based motivational interviewing technique to slightly overweight/obese individuals on individuals' body weight loss and gaining healthy eating habits. Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obese Women
- What is being tested?
- Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2021to 1 Jan 2023
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender : Female,
- Between 19-50 years of age,
- BMI ≥25.0 kg/m2,
- No condition that would prevent movement,
- No chronic disease (e.g. cardiovascular problems, neurological diseases, chronic respiratory diseases, diabetes, etc.)
- Individuals who signed the consent form and agreed to participate in the study were included.
Who cannot join
- Pregnant or planning to become pregnant,
- Menopausal,
- Breastfeeding,
- Chronic disease (e.g. cardiovascular problems, neurological diseases, chronic respiratory diseases, diabetes, etc.)
- History of eating disorders,
- Not simultaneously following another nutrition counseling program,
Show all 14Show fewer
- History of bariatric surgery,
- Using medications that affect body weight control,
- Abusing drugs and alcohol,
- Having voluntary vomiting behavior more than once a month,
- Purgative habits (use of laxatives, diuretics, etc.),
- On a special diet,
- Getting ≥17 points according to the Beck Depression Inventory or ≥30 points according to the Eating Attitudes Test (EAT) administered before the study were determined as exclusion criteria.
- Gender :Male
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman Unıversity
Muğla, Fethiye, 48300
About this study
The purpose of the study is to evaluate the effect of applying web-based motivational interviewing technique to slightly overweight/obese individuals on individuals' body weight loss and gaining healthy eating habits.
Hypotheses:
Read more
- The rate of decrease in body weight of individuals in the intervention group with motivational interviewing (MI) is higher than the control group.
- Individuals in the intervention group with MI show more improvement in healthy eating behaviors than the control group.
- The decrease in daily energy and fat intake of individuals in the intervention group with MI is higher than the control group.
- The rate of vegetables and fruits in daily food consumption of individuals in the intervention group with MI is higher than the control group.
All participants were interviewed one-on-one in the one-hour intervention group (n=40) and the control group (n=40) for a total of 6 times in two weeks for three months (12 weeks) in a 30-minute video conference environment.
Depending on the participant in the intervention group that received motivational interviews, the interview period was extended if necessary.
Read the detailed description
Participants were reached by snowball sampling method through an advertisement given on social media of a private diet center in Turkey. Participants were evaluated for suitability by phone interview. All volunteer participants were given detailed information about the study for one hour online. Online informed consent was obtained from participants who agreed to volunteer.
Before and at the end of the study, all participants were asked to fill out the Healthy Lifestyle Behavior Scale (HLBS), Food consumption frequency (which form), International Physical Activity Assessment Questionnaire (IPAQ-short form) and 24-h food consumption record for three consecutive days of the week (2 weekdays and 1 weekend) in an online data environment.
Participants were given portion training using the Turkish Ministry of Health's Turkish Nutrition Guide (TUBER). During the study (12 weeks), participants recorded 24-hour food consumption and physical activity records three days a week. The forms were sent to the researcher via online mail or social media (whatsapp) before the interview. Participants stated their height and were asked to measure their body weight on an empty stomach, without shoes and wearing light clothing, using a scale they used once a week, and their waist and hip circumferences were measured using a non-extensible tape measure.
In addition; the participants in the intervention group were given a medical nutrition treatment program along with motivational interview techniques. The control group was given only a medical nutrition program.
Daily energy needs in both groups were calculated using the Harris Benedict equation and a diet program was prepared to provide a weight loss of 0.5-1 kg per week. Accordingly, it was aimed to reduce the participant's daily energy intake by approximately 500-600 kcal, thus achieving a 10% kcal decrease in body weight. The diet program included 45-60% carbohydrates, 10-20% protein and 20-35% fat.
Measures Participant information form: All participants were female. In this study includes questions about marital status, people they live with, health status, use of nutritional supplements, smoking and alcohol use, number of meals, reasons for skipping meals, and whether they received help for weight loss.
Anthropometric measurements: height, waist, hip, body weight measurements were taken by the participant herself at the beginning and end of the study.
Healthy Lifestyle Behavior Scale (HLBS): The scale developed by Walker et al. measures the individual's health-enhancing behaviors related to a healthy lifestyle. The lowest total score obtained from the scale is 52, the highest total score is 208.
Food Consumption Frequency:
For each food, the expressions "every meal", "every day", "1-2 times a week", "3-4 times a week", "5-6 times a week", "2-3 times a month", "once a month or less often" were used and the consumption amounts were questioned.
Food consumption record:
International Physical Activity Assessment Questionnaire (IPAQ) Short Form:
It is used to determine the physical activity levels and sedentary lifestyles of adults.
- Conditions
- Weight Loss, Obese Women
- Being tested
- Diet
- Keywords
- motivational interviewing, obesity, nutrition, weight loss
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
Also called motivational interviewing
The effect of motivational interviewing techniques was examined in addition to diet treatment. The effect of motivational interviewing techniques on anthropometric measurements before and after the study was evaluated. The participants' indecisiveness was investigated and a self-directed "change conversation" was presented. Behavior change strategies including determining positive and negative aspects, using importance and confidence scales, and setting the agenda were applied by the researcher.
In the interviews that included motivational interviewing techniques:
- A participant-centered interview was conducted by collaborating with the participant.
- The researcher was impartial and did not assume the role of an expert.
- At the beginning of the interview, an evaluation of what was discussed in the previous week was made.
- First of all, an attempt was made to determine the agenda according to the topic the participant wanted to discuss.
- The importance scale was used (1-10).
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Not described Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
In the study, measurement information was obtained from the participants' own statements. The researcher provided online information to the participants about taking the measurements. The participants were asked to take their body weight (kg) measurements on an empty stomach once a week, at the same time in the morning, making sure to urinate and not drink water before the measurement, and on the same scale except during menstruation. The participants were asked to take their height measurements with a non-stretchable measuring tape, keeping their feet together and barefoot, in the Frankfort plane (eye and earlobe at the same level).
The researcher then calculated the body mass index (kg/m2) by dividing the body weight by the square of the height.
Measured: From enrollment to the end of treatment at 12 weeks
Waist/hip circumference ratio
Waist circumference measurements were requested to be taken from the midpoint between the last rib and the iliac crest using a flexible, non-elastic tape measure with a precision of 0.1 cm. When measuring hip circumference, the arms were hung to the sides, the legs were together, and the measurement was made with a non-flexible tape measure positioned under the iliac crest and on the hip at the widest part. The participant was asked to measure with the non-flexible tape measure parallel to the floor during the measurement. Waist/hip ratios [waist circumference (cm)/hip circumference (cm)] provide information about the participants' obesity types (gynoid or android). According to the World Health Organization data, a value of ≥ 0.85 cm in women is considered a health risk.
Measured: From start the end of 12 weeks
Results of Individuals According to Healthy Lifestyle Scale II (HLBS II)
The scale developed by Walker et al. measures the health-enhancing behaviors of the individual in relation to a healthy lifestyle. The scale is a questionnaire form consisting of subgroups. The subgroups are self-actualization, health responsibility, exercise, nutrition, interpersonal support and stress management. The validity and reliability study in Turkey was conducted by Bahar. The Crobach alpha internal consistency coefficient for the total HLBS was found to be 0.91. Each subgroup can be used independently. The score of the entire scale gives the healthy lifestyle behavior score. The lowest total score obtained from the scale is 52, and the highest total score is 208. As the total score increases, it is accepted that the individual has more healthy lifestyle behaviors.
Measured: From enrollment to the end of treatment at 12 weeks
Results of food consumption frequency
Participants were asked to fill out a food consumption frequency form including frequency and quantity in the last three months before and after the study. Food consumption frequency includes the basic food groups and the nutrients contained in these groups, namely milk and dairy products, meat and meat products, eggs, legumes, vegetables and fruits, oilseeds, bread and cereals, oil-sugar-sweets, other foods (sauces and ready meals) and beverages. For each of these foods, the expressions "every meal", "every day", "1-2 times a week", "3-4 times a week", "5-6 times a week", "2-3 times a month", "once a month or less" were used and consumption quantities were questioned. The amounts of food and beverages consumed were multiplied by "1" for "every day", "0.7855" for "5-6 times a week", "0.498" for "3-4 times a week", "0.2145" for "1-2 times a week", "0.067" for "every 15 days", and "0.033" for "once a month" to determine the average daily amounts.
Measured: From enrollment to the end of treatment at 12 weeks
Results of food consumption records (24 hour)
In the study, participants' food consumption records were taken every week for three days before and during the study. In order to better analyze the data collected during the study, the food consumption record data taken before the study was averaged for each of the two weeks; 12 weeks were evaluated as 6 time periods. Accordingly, in the study that lasted a total of 12 weeks, excluding the pre-study period, the 1st and 2nd weeks (time 1), 3rd and 4th weeks (time 2), 5th and 6th weeks (time 3), 7th and 8th weeks (time 4), 9th and 10th weeks (time 5), 11th and 12th weeks (time 6) were evaluated together.The evaluation of the participants' daily energy and nutrient intake was made using the Nutrition Information System (BeBIS) 9.0 computer package program. The nutrient values calculated through this program were evaluated according to the Turkey-Specific Nutrition Guide according to gender and age.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start20 Aug 2021
- Primary completion20 Nov 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study included a control group and an intervention group. All participants received medical nutrition therapy. Also, participants in one intervention group were exposed to motivational interviewing techniques for weight loss. The daily energy needs of the participants in the Medical Nutrition Program were calculated using the basal metabolic rate obtained with the Harris Benedict equation and the PAL (Physical activity level) value obtained from the average of three-day physical activity records (Total Energy Expenditure = BMR x PAL). In the study, a program was prepared in such a way that the daily energy intake of the participants in the nutritional treatment would provide a weight loss of 0.5-1 kg per week. Accordingly, it was aimed to reduce the participant's daily energy intake by approximately 500-600 kcal and provide a 10% kcal decrease in their body weight. A diet program containing 45-60% carbohydrate, 10-20% protein and 20-35% fat in the daily energy needs was applied.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel ERDEM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sibel ERDEM, Muğla Sıtkı Koçman University
- Investigators
- SİBEL ERDEM, LECTURER, Principal investigator, universityPELİN BİLGİÇ, ASSOC. PROF., Study director, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685432
- Sponsor's protocol ID
- E-72855364-050.01.044-299714
- Acronym
- OBESITY
- Status last verified
- May 2025
- First submitted
- 4 Nov 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing on Body Weight and Dietary Habits in Young Adult Women: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06685432
- Acronym / sponsor ID
- OBESITY / E-72855364-050.01.044-299714
- Conditions
- Weight Loss, Obese Women
- Keywords
- motivational interviewing, obesity, nutrition, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sibel ERDEMUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 12 Nov 2024 (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 purpose of the study is to evaluate the effect of applying web-based motivational interviewing technique to slightly overweight/obese individuals on individuals' body weight loss and gaining healthy eating habits.
Hypotheses:
- The rate of decrease in body weight of individuals in the intervention group with motivational interviewing (MI) is higher than the control group.
- Individuals in the intervention group with MI show more improvement in healthy eating behaviors than the control group.
- The decrease in daily energy and fat intake of individuals in the intervention group with MI is higher than the control group.
- The rate of vegetables and fruits in daily food consumption of individuals in the intervention group with MI is higher than the control group.
All participants were interviewed one-on-one in the one-hour intervention group (n=40) and the control group (n=40) for a total of 6 times in two weeks for three months (12 weeks) in a 30-minute video conference environment.
Depending on the participant in the intervention group that received motivational interviews, the interview period was extended if necessary.
Detailed description
Participants were reached by snowball sampling method through an advertisement given on social media of a private diet center in Turkey. Participants were evaluated for suitability by phone interview. All volunteer participants were given detailed information about the study for one hour online. Online informed consent was obtained from participants who agreed to volunteer.
Before and at the end of the study, all participants were asked to fill out the Healthy Lifestyle Behavior Scale (HLBS), Food consumption frequency (which form), International Physical Activity Assessment Questionnaire (IPAQ-short form) and 24-h food consumption record for three consecutive days of the week (2 weekdays and 1 weekend) in an online data environment.
Participants were given portion training using the Turkish Ministry of Health's Turkish Nutrition Guide (TUBER). During the study (12 weeks), participants recorded 24-hour food consumption and physical activity records three days a week. The forms were sent to the researcher via online mail or social media (whatsapp) before the interview. Participants stated their height and were asked to measure their body weight on an empty stomach, without shoes and wearing light clothing, using a scale they used once a week, and their waist and hip circumferences were measured using a non-extensible tape measure.
In addition; the participants in the intervention group were given a medical nutrition treatment program along with motivational interview techniques. The control group was given only a medical nutrition program.
Daily energy needs in both groups were calculated using the Harris Benedict equation and a diet program was prepared to provide a weight loss of 0.5-1 kg per week. Accordingly, it was aimed to reduce the participant's daily energy intake by approximately 500-600 kcal, thus achieving a 10% kcal decrease in body weight. The diet program included 45-60% carbohydrates, 10-20% protein and 20-35% fat.
Measures Participant information form: All participants were female. In this study includes questions about marital status, people they live with, health status, use of nutritional supplements, smoking and alcohol use, number of meals, reasons for skipping meals, and whether they received help for weight loss.
Anthropometric measurements: height, waist, hip, body weight measurements were taken by the participant herself at the beginning and end of the study.
Healthy Lifestyle Behavior Scale (HLBS): The scale developed by Walker et al. measures the individual's health-enhancing behaviors related to a healthy lifestyle. The lowest total score obtained from the scale is 52, the highest total score is 208.
Food Consumption Frequency:
For each food, the expressions "every meal", "every day", "1-2 times a week", "3-4 times a week", "5-6 times a week", "2-3 times a month", "once a month or less often" were used and the consumption amounts were questioned.
Food consumption record:
International Physical Activity Assessment Questionnaire (IPAQ) Short Form:
It is used to determine the physical activity levels and sedentary lifestyles of adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study included a control group and an intervention group. All participants received medical nutrition therapy. Also, participants in one intervention group were exposed to motivational interviewing techniques for weight loss. The daily energy needs of the participants in the Medical Nutrition Program were calculated using the basal metabolic rate obtained with the Harris Benedict equation and the PAL (Physical activity level) value obtained from the average of three-day physical activity records (Total Energy Expenditure = BMR x PAL). In the study, a program was prepared in such a way that the daily energy intake of the participants in the nutritional treatment would provide a weight loss of 0.5-1 kg per week. Accordingly, it was aimed to reduce the participant's daily energy intake by approximately 500-600 kcal and provide a 10% kcal decrease in their body weight. A diet program containing 45-60% carbohydrate, 10-20% protein and 20-35% fat in the daily energy needs was applied.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: Diet |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Gender : Female,
- Between 19-50 years of age,
- BMI ≥25.0 kg/m2,
- No condition that would prevent movement,
- No chronic disease (e.g. cardiovascular problems, neurological diseases, chronic respiratory diseases, diabetes, etc.)
Key exclusion criteria (14 listed)
- Pregnant or planning to become pregnant,
- Menopausal,
- Breastfeeding,
- Chronic disease (e.g. cardiovascular problems, neurological diseases, chronic respiratory diseases, diabetes, etc.)
- History of eating disorders,
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 |
|---|---|---|
| DietAlso: motivational interviewingThe effect of motivational interviewing techniques was examined in addition to diet treatment. The effect of motivational interviewing techniques on anthropometric measurements before and after the study was evaluated. The participants' indecisiveness was investigated and a self-directed "change conversation" was presented. Behavior change strategies including determining positive and negative aspects, using importance and confidence scales, and setting the agenda were applied by the researcher. In the interviews that included motivational interviewing techniques: 1. A participant-centered interview was conducted by collaborating with the participant. 2. The researcher was impartial and did not assume the role of an expert. 3. At the beginning of the interview, an evaluation of what was discussed in the previous week was made. 4. First of all, an attempt was made to determine the agenda according to the topic the participant wanted to discuss. 5. The importance scale was used (1-10). | Behavioural | intervention |
Primary outcome
Body mass index
Time frame: From enrollment to the end of treatment at 12 weeks
In the study, measurement information was obtained from the participants' own statements. The researcher provided online information to the participants about taking the measurements. The participants were asked to take their body weight (kg) measurements on an empty stomach once a week, at the same time in the morning, making sure to urinate and not drink water before the measurement, and on the same scale except during menstruation. The participants were asked to take their height measurements with a non-stretchable measuring tape, keeping their feet together and barefoot, in the Frankfort plane (eye and earlobe at the same level). The researcher then calculated the body mass index (kg/m2) by dividing the body weight by the square of the height.
Waist/hip circumference ratio
Time frame: From start the end of 12 weeks
Waist circumference measurements were requested to be taken from the midpoint between the last rib and the iliac crest using a flexible, non-elastic tape measure with a precision of 0.1 cm. When measuring hip circumference, the arms were hung to the sides, the legs were together, and the measurement was made with a non-flexible tape measure positioned under the iliac crest and on the hip at the widest part. The participant was asked to measure with the non-flexible tape measure parallel to the floor during the measurement. Waist/hip ratios [waist circumference (cm)/hip circumference (cm)] provide information about the participants' obesity types (gynoid or android). According to the World Health Organization data, a value of ≥ 0.85 cm in women is considered a health risk.
Results of Individuals According to Healthy Lifestyle Scale II (HLBS II)
Time frame: From enrollment to the end of treatment at 12 weeks
The scale developed by Walker et al. measures the health-enhancing behaviors of the individual in relation to a healthy lifestyle. The scale is a questionnaire form consisting of subgroups. The subgroups are self-actualization, health responsibility, exercise, nutrition, interpersonal support and stress management. The validity and reliability study in Turkey was conducted by Bahar. The Crobach alpha internal consistency coefficient for the total HLBS was found to be 0.91. Each subgroup can be used independently. The score of the entire scale gives the healthy lifestyle behavior score. The lowest total score obtained from the scale is 52, and the highest total score is 208. As the total score increases, it is accepted that the individual has more healthy lifestyle behaviors.
Results of food consumption frequency
Time frame: From enrollment to the end of treatment at 12 weeks
Participants were asked to fill out a food consumption frequency form including frequency and quantity in the last three months before and after the study. Food consumption frequency includes the basic food groups and the nutrients contained in these groups, namely milk and dairy products, meat and meat products, eggs, legumes, vegetables and fruits, oilseeds, bread and cereals, oil-sugar-sweets, other foods (sauces and ready meals) and beverages. For each of these foods, the expressions "every meal", "every day", "1-2 times a week", "3-4 times a week", "5-6 times a week", "2-3 times a month", "once a month or less" were used and consumption quantities were questioned. The amounts of food and beverages consumed were multiplied by "1" for "every day", "0.7855" for "5-6 times a week", "0.498" for "3-4 times a week", "0.2145" for "1-2 times a week", "0.067" for "every 15 days", and "0.033" for "once a month" to determine the average daily amounts.
Results of food consumption records (24 hour)
Time frame: From enrollment to the end of treatment at 12 weeks
In the study, participants' food consumption records were taken every week for three days before and during the study. In order to better analyze the data collected during the study, the food consumption record data taken before the study was averaged for each of the two weeks; 12 weeks were evaluated as 6 time periods. Accordingly, in the study that lasted a total of 12 weeks, excluding the pre-study period, the 1st and 2nd weeks (time 1), 3rd and 4th weeks (time 2), 5th and 6th weeks (time 3), 7th and 8th weeks (time 4), 9th and 10th weeks (time 5), 11th and 12th weeks (time 6) were evaluated together.The evaluation of the participants' daily energy and nutrient intake was made using the Nutrition Information System (BeBIS) 9.0 computer package program. The nutrient values calculated through this program were evaluated according to the Turkey-Specific Nutrition Guide according to gender and age.
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 11 May 2025.
- Individual participant dataSharing planned: No
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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.
SİBEL ERDEM, LECTURER principal investigator
university
PELİN BİLGİÇ, ASSOC. PROF. study director
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 Diet in people with Weight Loss and Obese Women, run by Sibel ERDEM 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 6 inclusion and 14 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 11 May 2025. 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 mass index (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 5 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 11 May 2025.