NCT04983147

Brief Summary

This study was conducted to examine the effectiveness of the training provided to women with obesity based on the Health Belief Model on women's beliefs regarding obesity and obesity management of the women. Study population included 18 to 65 years old women with obesity and the study sample included 128 women (64 in the control group and 64 in the experimental group) determined by power analysis. Randomized controlled, single-blind clinical study included a total of 128 obesity woman

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

May 12, 2021

Last Update Submit

July 19, 2021

Conditions

Outcome Measures

Primary Outcomes (10)

  • Introductory Information Form (questionnaire)

    An introductory information form prepared by the researcher based on relevant literature was filled out by participants it included 15 questions regarding the age, marital status, family type, education status, social security, profession, income, and having children, doing exercise previously, the reason for quitting exercise, seeing a dietician and following a prescribed diet, and if so, the reason for abandoning the diet.

    up to 12 weeks

  • Health Belief Model Scale in Obesity (questionnaire-scale)

    It is a questionnaire used as a measurement tool. Its validity and reliability have been proven. individuals to lose weight evaluate their beliefs and attitudes towards The scale consists of 32 items in total. The cronbach alpha coefficient is 0.80. health belief, sensitivity, seriousness, benefit and five sub-dimensions that can be used independently of each other, including the perception of obstacles exists.The scale is a 5-point Likert type scale for each item. The total scale score average of the survey is not calculated. Each sub-scale The scores of the items belonging to the sub-scale of the scale are calculated by adding up. If each item in the scale is not answered, the number of items answered The corresponding ratings are calculated by summing, and the responses on that subscale are calculated. divided by the number of items.

    up to 12 weeks

  • Health Belief Model Scale in Obesity-Importance of Health (questionnaire-scale)

    The importance of health; the level of importance individuals give to their health and consists of eight items (1, 2, 3, 4, 5, 6, 7, 8). The higher the score, the higher the health level.

    up to 12 weeks

  • Health Belief Model Scale in Obesity- Perceived sensitivity (questionnaire-scale)

    Perceived sensitivity; health problems and complications that may develop due to obesity. at what level they find themselves susceptible, and interventions for obesity evaluate what level they find useful and choose from four items (12, 13, 14, 16). consists of. The higher the score, the higher the sensitivity level.

    up to 12 weeks

  • Health Belief Model Scale in Obesity- Perceived severity (questionnaire-scale)

    Perceived seriousness; At what level do individuals consider obesity a serious disease? evaluates what they see as their own and consists of four items (9, 10, 11, 17).

    up to 12 weeks

  • Health Belief Model Scale in Obesity- Perceived benefit (questionnaire-scale)

    Perceived benefit; what individuals gain in terms of their health when they manage obesity shows the level of awareness of the benefits and consists of 8 items (21, 22, 24, 25, 26, 27, 28, 32). As the score increases, the level of perception increases as a benefit.

    up to 12 weeks

  • Health Belief Model Scale in Obesity- Perceived barrier (questionnaire-scale)

    Perceived barrier; health recommendations of individuals for obesity. It shows the level of barriers they perceive in practice and consists of eight items. (15, 18, 19, 20, 23, 29, 30, 31).It is understood that as the perceived obstacle score decreases, the level of disability decreases.

    up to 12 weeks

  • Height Meter

    Length Meter: SECA brand 20 - 207 cm capacity, height measurement with 1mm accuracy It is the length measuring stick that provides the opportunity.

    up to 12 weeks

  • weighing machine

    weighing machine: SECA brand 200 kg capacity, 100 g precision weighing, wide and non-slip platform, large LCD number display scale.

    up to 12 weeks

  • body mass index calculation

    weight and height will be combined to report BMI in kg/m\^2 Weight assessment was made after the application. The change in body mass index was evaluated. It was determined whether women lost weight or not.

    up to 12 weeks

Secondary Outcomes (9)

  • Health Belief Model Scale in Obesity ((questionnaire-scale)

    through study completion, an average of 1 year

  • Health Belief Model Scale in Obesity-Importance of Health (questionnaire-scale)

    through study completion, an average of 1 year

  • Health Belief Model Scale in Obesity- Perceived sensitivity (questionnaire-scale)

    through study completion, an average of 1 year

  • Health Belief Model Scale in Obesity- Perceived severity (questionnaire-scale)

    through study completion, an average of 1 year

  • Health Belief Model Scale in Obesity- Perceived benefit (questionnaire-scale)

    through study completion, an average of 1 year

  • +4 more secondary outcomes

Study Arms (5)

health belief model based training manuel

EXPERIMENTAL

A training manual entitled "Do Not Stay Silent Towards Obesity" was prepared by the researcher to guide women in obesity management by affecting their beliefs on obesity in a positive way.

Other: Obesity Training Based on Health Belief Model

powerpoint presentation with computer

EXPERIMENTAL

The presentation prepared based on the Health belief model was used in group training.

Other: Obesity Training Based on Health Belief Model

video for obesity based on health beliefs

EXPERIMENTAL

In the literature; It is explained that the educator's use of representations such as video is more effective than verbal expression and reading, and facilitates learning both by hearing and seeing.For this reason, videos that will create awareness about the subject in the trainings were prepared by the researcher and used in the trainings.

Other: Obesity Training Based on Health Belief Model

successful patients in obesity management

EXPERIMENTAL

Real-life stories of people who could manage obesity before and thought themselves healthier compared to their previous condition were shared with the group. People were invited to the trainings who had obesity before and managed to lose weight and trainings were given in the affective field.

Other: Obesity Training Based on Health Belief Model

Post-training follow-up

EXPERIMENTAL

After the trainings given to women were completed, women were included in the follow-up program.For 6 mounts. This application will only be made in the experimental group. This follow-up will increase motivation and answer questions regarding obesity management. It was made by calling every 15 days.It will be made by phone call.

Other: Post-training follow-up

Interventions

Trainig was given with initiatives for cognitive and affective learning areas within the framework of health belief model.7 weeks.This application will only be made in the experimental group.

health belief model based training manuelpowerpoint presentation with computersuccessful patients in obesity managementvideo for obesity based on health beliefs

After 7 weeks of training to women were completed, women were included in the follow-up program.For 6 mounts. This application will only be made in the experimental group.It will be made by phone call. This follow-up will increase motivation and answer questions regarding obesity management. It was made by calling every 15 days.

Post-training follow-up

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with a waist circumference ≥88 cm
  • with no previous training regarding obesity
  • being at least a primary school graduate
  • having no chronic diseases or mental or psychological disability limiting daily life activities

You may not qualify if:

  • having an obesity surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süheyla Yaralı

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Süheyla Yaralı

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

May 12, 2021

First Posted

July 30, 2021

Study Start

April 1, 2017

Primary Completion

August 1, 2017

Study Completion

December 2, 2018

Last Updated

July 30, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations