NCT06123273

Brief Summary

This study aimed to investigate the effect of an exercise-oriented training on physical activity level and exercise awareness in overweight and obese women. Participants will randomized into intervention group (IG) and control group (CG) and followed-up for three months. The International Physical Activity Questionnaire Short Form (IPAQ) will be applied to both groups at the beginning and end of the study to determine the level of physical activity, and the Exercise Health Belief Model Scale (EHBM) will be applied to evaluate the exercise awareness level, and anthropometric measurements (weight, body mass index, waist circumference) will recorded. The CG will receive no other interventions other than routine recommendations. The IG will be given face-to-face training to increase exercise awareness along with routine recommendations after the first meeting, and they will be contacted by phone every two weeks for three months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

September 5, 2023

Last Update Submit

November 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The International Physical Activity Questionnaire Short Form was used to determine the physical activity level at the beginning and end of the study

    The International Physical Activity Questionnaire Short Form was used to determine the physical activity level at the beginning and end of the study. The minimum score is \<600 Maximal Exercise Test (MET) -minute/week while the maximum score is \>3000 MET-minute/week . High score means high exercise belief.

    3 months

Secondary Outcomes (3)

  • Exercise Health Belief Model Scale

    3 months

  • Anthropometric measure

    3 months

  • Body fat

    3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group was given an exercise-oriented training

Behavioral: Exercise-oriented training

Control group

NO INTERVENTION

The control group was given only routine recommendations

Interventions

IG received an exercise-oriented training with a 20-minute presentation including graphics, in line with clinical guidelines, in addition to routine recommendations. The training included information about the benefits of exercise and the harms of a sedentary life, the relationship between exercise and chronic diseases, suggestions to have a more active lifestyle and on how to exercise, the duration and form of exercise necessary for a healthy life, and the things to be considered while exercising. During the three-month follow-up, the subjects in the IG were called every two weeks to ask about their weight measurements, their level of exercise, and how much they walked. The subjects' questions, if any, were answered, and the interview was completed by making exercise suggestions.

Also known as: close follow-up
Intervention group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale obese participants were enrolled
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 25-34.9 g/m2
  • Female
  • Turkish

You may not qualify if:

  • Individuals with disabilities to exercise
  • pregnant/breastfeeding women
  • Individuals with Stage 2-3 obesity (BMI \>35 kg/m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Hospital

Erzurum, 25040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityOverweightSedentary Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Zehranur Kacar

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Family Medicine

Study Record Dates

First Submitted

September 5, 2023

First Posted

November 8, 2023

Study Start

August 1, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations