Theory-Based Obesity Intervention Program for Women

NCT ID: NCT05027750

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-05

Study Completion Date

2021-12-24

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Application of The Theory of Planned Behaviour For Weight Control

Intervention Type BEHAVIORAL

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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sakarya University

OTHER

Sponsor Role lead

Responsible Party

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SEDA GOGER

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sakarya Provincial Directorate of Health

Sakarya, Adapazarı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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162146620500104273

Identifier Type: -

Identifier Source: org_study_id

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