Theory-Based Obesity Intervention Program for Women

Obesity Clinical Trial

Official title:

Application Of The Theory Of Planned Behavior For Weight Control In Women: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027750
• Other study ID #: 162146620500104273
• Status: Completed
• Phase: N/A
• Start date: April 5, 2021
• Est. completion date: December 24, 2021

Study information

• Verified date: August 2021
• Source: Sakarya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 24, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Application of The Theory of Planned Behaviour For Weight Control
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.

Locations

Country	Name	City	State
Turkey	Sakarya Provincial Directorate of Health	Sakarya	Adapazari

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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).	6 months
Secondary	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.	6 months
Secondary	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	6 months