NCT06436443

Brief Summary

The use of technology-based education and counseling services in the self-management of gestational diabetes contributes to better control of blood sugar levels, motivation and increased self-efficacy in women. Therefore, this study was planned as interventional research to determine the effect of SMS counseling given to individuals with gestational diabetes on self-efficacy and knowledge levels. This study was conducted descriptively with 95 patients with gestational diabetes who were treated in the endocrine service of a university hospital between August 15, 2021 and April 24, 2022. Personal information form created by the researchers, The Self-Efficacy Scale in Gestational Diabetes, and Diabetes Knowledge Scale were used to collect data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

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 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 24, 2024

Last Update Submit

May 24, 2024

Conditions

Keywords

Gestational diabetes mellitus,Self-Efficacy,SMS Counseling.

Outcome Measures

Primary Outcomes (2)

  • Diabetes Knowledge Scale

    This scale was first developed by Dunn et al.13 to measure diabetes knowledge. Afterward, it was developed by Carolan et al. to examine three effect domains: pregnant women's GDM knowledge, nutritional values, and GDM self-management principles. The scale consists of 18 questions. Cronbach's alpha value of the total scale was determined as 0.654.

    5 Minute

  • The Self-Efficacy Scale in Gestational Diabetes

    This is a five-point Likert-type scale consisting of 23 items developed by Polat and Avdal in 2019 to evaluate the self-efficacy levels of individuals with gestational diabetes. It consists of four sub-dimensions: "diet-weight management"; "complication measures"; "compliance with nutrition education"; "medical therapy practices". As the total score on the scale increases, the level of self-efficacy increases, as well. Cronbach's alpha value of the total scale was determined as 0.654.

    5 minute

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

In addition to routine physician check-ups, an SMS group was created for the individuals in the intervention group, and basic information messages for diabetes control were sent to this group at regular intervals. In addition, individuals asked questions via this group. At the end of the eight-week follow-up, the data collection forms were filled out again and the study was terminated.

Other: SMS Counseling

Control Group

NO INTERVENTION

The same data collection forms were filled out at the first interview and eight weeks later by the pregnant women in the control group, and they continued to receive routine follow-ups.

Interventions

In addition to routine physician check-ups, an SMS group was created for the individuals in the intervention group, and basic information messages for diabetes control were sent to this group at regular intervals. In addition, individuals asked questions via this group. At the end of the eight-week follow-up, the data collection forms were filled out again and the study was terminated.

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women were taken.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with gestational diabetes,
  • being in the 30th week of pregnancy,
  • having a smartphone,
  • volunteering to participate in the study,
  • having no communication problems,
  • having no psychiatric problems

You may not qualify if:

  • being non-literate,
  • having communication problems (hearing or sight),
  • not volunteering to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, 15000, Turkey (Türkiye)

Location

Related Publications (3)

  • Hemmati Maslakpak M, Razmara S, Niazkhani Z. Effects of Face-to-Face and Telephone-Based Family-Oriented Education on Self-Care Behavior and Patient Outcomes in Type 2 Diabetes: A Randomized Controlled Trial. J Diabetes Res. 2017;2017:8404328. doi: 10.1155/2017/8404328. Epub 2017 Nov 22.

  • Guo Y, Zhou L, Sun B, Wang C, Zhang J. Application of online-offline integrated medical care management in patients with gestational diabetes. Ginekol Pol. 2021;92(10):720-725. doi: 10.5603/GP.a2021.0054. Epub 2021 Apr 29.

  • Miremberg H, Ben-Ari T, Betzer T, Raphaeli H, Gasnier R, Barda G, Bar J, Weiner E. The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial. Am J Obstet Gynecol. 2018 Apr;218(4):453.e1-453.e7. doi: 10.1016/j.ajog.2018.01.044. Epub 2018 Feb 7.

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Single (Participant) They did not know if they were in the control and intervention group at the time of randomization.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2024

First Posted

May 31, 2024

Study Start

August 15, 2021

Primary Completion

March 15, 2022

Study Completion

April 24, 2022

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

All authors contributed to the interpretation, writing, and approval of the final manuscript.

Locations