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NCT Number: NCT05027750

Theory-Based Obesity Intervention Program for Women

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.

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Key information

Conditions

Obesity Behavior Body Weight Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya Provincial Directorate of Health

Sakarya, Adapazarı, 54000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application of The Theory of Planned Behaviour For Weight Control

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.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Change in body mass index

    Time frame: 6 months

    Weight and height will be combined to report BMI in kg/m^2. The change in body mass index will be evaluated.

  2. Change in waist/hip ratio

    Time frame: 6 months

    Waist and hip will be combined to report Waist/Hip in cm. The change in waist/hip ratio will be evaluated

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 30, 2021
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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