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Theory-Based Obesity Intervention Program for Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05027750
Enrollment
78
Registered
2021-08-30
Start date
2021-04-05
Completion date
2021-12-24
Last updated
2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, women, health behaviors, Theory of Planned Behavior

Brief 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.

Interventions

BEHAVIORALApplication 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.

Sponsors

Sakarya University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Healthy Lifestyle Behaviors-II Scale6 monthsHealthy 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 Form6 monthsInternational 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).

Secondary

MeasureTime frameDescription
Change in body mass index6 monthsWeight and height will be combined to report BMI in kg/m\^2. The change in body mass index will be evaluated.
Change in waist/hip ratio6 monthsWaist and hip will be combined to report Waist/Hip in cm. The change in waist/hip ratio will be evaluated

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026