ObesityNCT05027750
Theory-Based Obesity Intervention Program for Women
A study of Obesity, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of education and counseling given to women according to the Theory of Planned Behavior on weight management. This study will be conducted as a single-blind randomized controlled study consisting of intervention and control groups. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2021to 24 Dec 2021
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study
- Being a woman in the age group of 18-49 years
- Having a body mass index (BMI) of 25.0-30.0 kg/m2 (overweight) or >30.0 kg/m2 (obese)
- Not going through menopause
- Not having diabetes
- Not having thyroid disease
Show all 15Show fewer
- Not using hormonal contraceptive pills
- Not having polycystic ovarian disease
- Not having a metabolic disease
- Not having Cushing's syndrome
- Not having a disease that prevents physical activity
- Not having hypertension
- Not being pregnant or breastfeeding
- Owning and using a smart phone
- Having a mail account in Google and being able to use it
Who cannot join
- Women who do not meet the inclusion criteria
- Not volunteering to participate in the study
- Women with communication problems
- Women who did not give consent at any stage of the study and who quit the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya Provincial Directorate of Health
Sakarya, Adapazarı, 54000
About this study
Official title: Application Of The Theory Of Planned Behavior For Weight Control In Women: A Randomized Controlled Study
The aim of this study is to examine the effect of education and counseling given to women according to the Theory of Planned Behavior on weight management. This study will be conducted as a single-blind randomized controlled study consisting of intervention and control groups. A total of 78 overweight and obese women included in the study. The participants assigned to either of the groups by the block randomization method. A training program consisting of a total of five sessions applied to the intervention group, and counseling will be provided for 6 months. The data will be analyzed with Statistical Package for Social Sciences (SPSS) 22.0 package program.
- Conditions
- Obesity
- Being tested
- Application of The Theory of Planned Behaviour For Weight Control
- Keywords
- obesity, women, health behaviors, Theory of Planned Behavior
- Medical subject headings
- Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of The Theory of Planned Behaviour For Weight ControlBehavioural
The training to be imparted to the participants was applied online in groups of 5-6 people via the Google Meet program. Obesity training consisting of a total of five sessions. Each session lasted for approximately 30 minutes. After the training given to intervention group, the women will be followed-up for 6 months. The women in the intervention group will be given counseling service by the researchers, and their status will be evaluated every month.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The selected womens were associated with obesity risk factors about obesity (overweight) or obese and between 18-49 years old) and randomly assigned to the experimental group. Obesity training consisting of a total of five sessions structured according to Theory of Planned Behavior was scheduled for the intervention group. Each session lasted for approximately 30 minutes. Receives: Behavioral: Application of The Theory of Planned Behaviour For Weight Control |
| Control | No intervention | The control group of the Randomized Controlled Trial (RCT) was composed of 39 womens (between 18-49 years old) randomly assigned to the control group who are BMI was between 25.0-29.9 or BMI was between ≥30.0 according to the risk rating scales. A standard obesity training consisting of a single session was scheduled for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Lifestyle Behaviors-II Scale
Healthy Lifestyle Behaviors-II Scale aims to measure the health promotion behaviors of individuals. The scale consists of 52 items. It is a four-point Likert-type scale (1: "never," 2: "sometimes," 3: "often," and 4: "regularly"). The lowest score that can be obtained is 52, and the highest score is 208. High scores indicate that the individual practices the specified health behaviors at a high level.
Measured: 6 months
International Physical Activity Questionnaire Short Form
International Physical Activity Questionnaire Short Form, the intensity (mild, moderate, and severe) of physical activity is taken into account to accommodate different types of physical activities. The questionnaire provides information about sitting, walking, and the time spent in moderately intense and vigorous activities. Vigorous physical activities have a value of 8.0 MET, moderate activities have a value of 4.0 MET, and walking has a value of 3.3 MET. The minute and frequency (day) values of the relevant activities are multiplied by the MET values. The total physical activity value is obtained by summing the multiplication values obtained at the last stage. Accordingly, the physical activity levels of individuals are classified as physically inactive (<600 MET-min/week), low physical activity (600-3000 MET-min/week), and adequate physical activity (health benefits) (>3000 MET-min/week).
Measured: 6 months
Secondary outcomes (2)
Change in body mass index
Weight and height will be combined to report BMI in kg/m^2. The change in body mass index will be evaluated.
Measured: 6 months
Change in waist/hip ratio
Waist and hip will be combined to report Waist/Hip in cm. The change in waist/hip ratio will be evaluated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start5 Apr 2021
- Primary completion18 Jun 2021
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDA GOGER, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027750
- Sponsor's protocol ID
- 162146620500104273
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 17 Jul 2023
- Results posted
- No
- 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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Of The Theory Of Planned Behavior For Weight Control In Women: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05027750
- Acronym / sponsor ID
- 162146620500104273
- Conditions
- Obesity
- Keywords
- obesity, women, health behaviors, Theory of Planned Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 30 Aug 2021 (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 aim of this study is to examine the effect of education and counseling given to women according to the Theory of Planned Behavior on weight management. This study will be conducted as a single-blind randomized controlled study consisting of intervention and control groups. A total of 78 overweight and obese women included in the study. The participants assigned to either of the groups by the block randomization method. A training program consisting of a total of five sessions applied to the intervention group, and counseling will be provided for 6 months. The data will be analyzed with Statistical Package for Social Sciences (SPSS) 22.0 package program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Application of The Theory of Planned Behaviour For Weight ControlThe selected womens were associated with obesity risk factors about obesity (overweight) or obese and between 18-49 years old) and randomly assigned to the experimental group. Obesity training consisting of a total of five sessions structured according to Theory of Planned Behavior was scheduled for the intervention group. Each session lasted for approximately 30 minutes. |
| Control | No intervention | –The control group of the Randomized Controlled Trial (RCT) was composed of 39 womens (between 18-49 years old) randomly assigned to the control group who are BMI was between 25.0-29.9 or BMI was between ≥30.0 according to the risk rating scales. A standard obesity training consisting of a single session was scheduled for the control group. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Volunteering to participate in the study
- Being a woman in the age group of 18-49 years
- Having a body mass index (BMI) of 25.0-30.0 kg/m2 (overweight) or >30.0 kg/m2 (obese)
- Not going through menopause
- Not having diabetes
Key exclusion criteria (4 listed)
- Women who do not meet the inclusion criteria
- Not volunteering to participate in the study
- Women with communication problems
- Women who did not give consent at any stage of the study and who quit the study
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 |
|---|---|---|
| Application of The Theory of Planned Behaviour For Weight ControlThe training to be imparted to the participants was applied online in groups of 5-6 people via the Google Meet program. Obesity training consisting of a total of five sessions. Each session lasted for approximately 30 minutes. After the training given to intervention group, the women will be followed-up for 6 months. The women in the intervention group will be given counseling service by the researchers, and their status will be evaluated every month. | Behavioural | Intervention |
Primary outcome
Healthy Lifestyle Behaviors-II Scale
Time frame: 6 months
Healthy Lifestyle Behaviors-II Scale aims to measure the health promotion behaviors of individuals. The scale consists of 52 items. It is a four-point Likert-type scale (1: "never," 2: "sometimes," 3: "often," and 4: "regularly"). The lowest score that can be obtained is 52, and the highest score is 208. High scores indicate that the individual practices the specified health behaviors at a high level.
International Physical Activity Questionnaire Short Form
Time frame: 6 months
International Physical Activity Questionnaire Short Form, the intensity (mild, moderate, and severe) of physical activity is taken into account to accommodate different types of physical activities. The questionnaire provides information about sitting, walking, and the time spent in moderately intense and vigorous activities. Vigorous physical activities have a value of 8.0 MET, moderate activities have a value of 4.0 MET, and walking has a value of 3.3 MET. The minute and frequency (day) values of the relevant activities are multiplied by the MET values. The total physical activity value is obtained by summing the multiplication values obtained at the last stage. Accordingly, the physical activity levels of individuals are classified as physically inactive (<600 MET-min/week), low physical activity (600-3000 MET-min/week), and adequate physical activity (health benefits) (>3000 MET-min/week).
2 secondary outcomes
Change in body mass index
Time frame: 6 months
Change in waist/hip ratio
Time frame: 6 months
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 17 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Obesity
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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 of Obesity, run by Sakarya 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 15 inclusion and 4 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 17 Jul 2023. 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?
Healthy Lifestyle Behaviors-II Scale (time frame: 6 months). The study lists 2 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 17 Jul 2023.