NCT05217290

Brief Summary

The research will be carried out in order to investigate the effect of health education given to prediabetes patients by video conference method on self-management and exercise. The work will be carried out in two stages. In the first stage, the validity and reliability study of the Scale for Process of Exercise Engagement (SPEE) that was developed on prediabetes patients will be conducted and the scale will be adapted to the Turkish society. In the second stage, the effect of health education, which was prepared on the basis of the Transtheoretic Model and will be given by video conferencing, on the exercise status of prediabetes patients, on hunger, postprandial blood sugar, cholesterol, LDL, HDL, triglyceride, blood pressure, HbA1c, BMI, weight, waist circumference measurements will be evaluated. In this research, the exercise change stages dimension of the Transtheoretic Model will be discussed and the trainings will be planned according to these stages.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

September 7, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

September 7, 2021

Last Update Submit

January 19, 2022

Conditions

Outcome Measures

Primary Outcomes (11)

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    Among the metabolic control indicators of the traning group; * HbA1c value will be lower than the control group. * Cholesterol value will be lower than the control group. * LDL value will be lower than the control group * HDL value will be higher than the control group. * Triglyceride value will be lower than the control group.

    6 months

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    The blood pressure values (mmHg) of the group, who have been reminded by the health education given by video conferencing method and mobile communication tools, will be lower than the control group (manual sphygmomanometer).

    6 months

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    The weight (kg) of the group that has been reminded by the health education given by video conferencing method and mobile communication tools will be lower than the control group (Weighing instrument).

    6 months

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    BMI (kg/m2) of the group that has been reminded by the health education given by video conferencing method and mobile communication tools will be lower than the control group (Weighing instrument, height meter).

    6 months

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    Waist circumference (cm) of the group that has been reminded by the health education given by video conferencing method and mobile communication tools will be lower than the control group (tape measure).

    6 months

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    Compared to the control group, the mean score of participation developing awareness (min:4-max:20) will be higher for the group who have been reminded with health education given by video conferencing method and mobile communication tools Scale for Process of Exercise Engagement . Higher scores on the Developing Awareness (DA), represents higher levels for psychological and behavioral transitions, represents

    6 months

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    Compared to the control group, the mean score of participation creating the health blueprint (min:3-max:15) will be higher for the group who have been reminded with health education given by video conferencing method and mobile communication tools (Scale for Process of Exercise Engagement. Higher scores on the creating the health blueprint, represents higher levels for psychological and behavioral transitions, represents

    6 months

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    Compared to the control group, the mean score of participation driving force (min:6-max:30) will be higher for the group who have been reminded with health education given by video conferencing method and mobile communication tools Scale for Process of Exercise Engagement. Higher scores on the creating the driving force, represents higher levels for psychological and behavioral transitions, represents

    6 months

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    Compared to the control group, the mean score of participation spontaneous regular exercise (min:4-max20) will be higher for the group who have been reminded with health education given by video conferencing method and mobile communication tools (Scale for Process of Exercise Engagement. Higher scores on the creating the spontaneous regular exercise, represents higher levels for psychological and behavioral transitions, represents

    6 months

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    Compared to the control group, the mean score of participation resistive force (min: 4-max:20) will be lower for the group who have been reminded with health education given by video conferencing method and mobile communication tools (Scale for Process of Exercise Engagement. Higher scores on the creating the resistive force, represents lower levels for psychological and behavioral transitions, represents

    6 months

  • The Effect of Health Education Given to Prediabetes Patients by Video Conferencing on Self-Management and Exercise Status

    points (max:, min:) Developing awareness =4\~20, Creating the health blueprint=3\~15 Driving force= ,6\~30 Resistive force= 4\~20, Spontaneous regular exercise=4\~20

    6 months

Study Arms (2)

experiment group

EXPERIMENTAL
Behavioral: transtheoretical model

control group

NO INTERVENTION

Interventions

The Transtheoretic Model is a conscious behavior change model and argues that behavior change is a process and that the attempts made in accordance with the change stage of the individual facilitate the change, otherwise resistance to behavior change is developed.

experiment group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals, diagnosed with prediabetes,
  • years old,
  • A citizen of the Republic of Turkey,
  • Not using drugs effective on blood glucose metabolism,
  • No vision or hearing problems,
  • No cognitive or psychiatric problems,
  • Without diagnosis of malignancy,
  • Not pregnant,
  • Those who have a smartphone, tablet or computer, or a family member with devices with this feature, who have no problems with internet access,
  • Able to use mobile phone and read messages,
  • Residing in Kilis city center,
  • Open to communication and cooperation,
  • Literate,
  • willing to participate in the study

You may not qualify if:

  • Individuals who, don't have a smartphone, tablet, or computer, or don't have a family member with this feature,
  • Having problems with internet access,
  • are reluctant to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prediabetic State

Interventions

Transtheoretical Model

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Belief ModelModels, TheoreticalInvestigative TechniquesModels, Psychological

Central Study Contacts

melek öztürk, PhD student

CONTACT

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
lecturer

Study Record Dates

First Submitted

September 7, 2021

First Posted

February 1, 2022

Study Start

January 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

February 1, 2022

Record last verified: 2022-01