Health-promoting Lifestyle Education on Women With Gestational Diabetes Mellitus

NCT03881956 | Completed

• 1 other identifier: 443983
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study the effect of the Health-Promoting Lifestyle Education Program (HPLEP) provided to women with GDM on maternal and neonatal health was investigated. The education program and also usual care applied to the intervention group, only usual care applied to the control group.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

gestational diabetes; health-promoting lifestyle; maternal and neonatal health; education

Outcome Measures

Primary Outcomes (4)

• Change of Health-Promoting Lifestyle Profile II (HPLP II) scores

  Primary outcome of women with GDM was their healthy lifestyle behaviours measured on the HPLP-II. This scale, developed by Walker et al. (1987) on the basis of Pender's health promotion model, measures the health-promoting behaviours associated with a health-promoting lifestyle. The scale was revised in 1996 and designated as HPLP-II (Walker et al. 1996). Bahar et al. (2008) tested the scale's validity and reliability in Turkish. The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.92. Higher scores on the scale indicate a higher performance level of the determined health-promoting behaviours. The scale consists of 52 items under the six subscales of spiritual growth, nutrition, physical activity, health responsibility, interpersonal relations and stress management. The lowest and highest possible scores on the scale are 52 and 208, respectively.

  Four weeks after randomization and within postpartum 6th week

• Change of Short Form 36 Health Survey (SF-36) scores

  Quality of life of the women was measured using the SF-36. This scale, developed by Ware in 1987, is globally referred to as SF-36, as this acronym has been commonly used in all studies since the development of the scale. SF-36 is a self-assessment scale, consisting of 36 questions under eight subscales: physical functioning, physical role limitation, social functioning, mental health, energy-vitality, bodily pain, general health perceptions and emotional role limitation (Ware \& Sherbourne 1992). Pınar (1995) tested the scale's validity and reliability in Turkish. The Cronbach's alpha internal consistency value was found to be 0.91.When the scores of each subscale in the scale increase, health-related quality of life also increases. Subscales are all separately scored. "0" point indicates poor health and "100" points states good health (Ware and Sherbourne, 1992).

  Four weeks after randomization and within postpartum 6th week

• Change of Center for Epidemiologic Studies Depression Scale (CES-D) scores

  CES-D Scale was used to assess symptoms of depression in women. This short scale, developed by Radloff (1977) to measure depressive symptoms, can be administered to both the general population and specially selected groups. The CES-D consists of 20 items, each of which are scored between 0 and 3. The 4th, 8th, 12th, and 16th items are reversely scored. The total score ranges between 0 and 60, and a score of 16 and higher suggests the risk of depression, while lower scores on the CES-D Scale indicate decreased risks for depression. The scale measures symptoms experienced over the most recent week of time according to frequency of occurrence, where 0= Rarely or never, 1= Sometimes, 2= Often, and 3= Usually or always. Yilmaz (2010) tested the scale's validity and reliability in Turkish. The Cronbach's alpha value was found to be 0.85 for the entire scale.

  Four weeks after randomization and within postpartum 6th week

• Pre-test and post-test scores

  Women's level of knowledge about GDM was measured using pre-test and post-test question form.This form, developed by the researcher in accordance with the literature, includes questions about GDM and healthy lifestyle. There are 16 questions in the question form. The minimum score that the women in the intervention group could get from the pre-test and post-test was "0" and the maximum score was "16".

  After randomization up to one week

Secondary Outcomes (2)

• Postpartum diabetes control of women

  within postpartum 6th week

• Postpartum characteristics of neonates

  in postpartum first day

Study Arms (1)

Women with gestational diabetes

OTHER

88 women with gestational diabetes (46 for the intervention group and 42 for the control group) were in the arm.

Behavioral: Health-promoting lifestyle education program

Interventions

Health-promoting lifestyle education program BEHAVIORAL

The intervention group were included in the health-promoting lifestyle education program. The education program consisted of three 45-min sessions, which included a face-to-face lecture with the dissemination and presentation of written and visual materials. Each participant in the intervention group was given the Health-Promoting Lifestyle Booklet and the Diary of a Woman with GDM card. The booklet features all of the health-promoting practices (self-monitoring of blood glucose, nutrition, physical activity, stress, sleeping, smoking, self-care and breastfeeding). The Diary of a Woman with GDM card features the daily program that women should follow (the hours for main meals and snacks, insulin hours, etc.). The education and counseling were maintained through follow-up via phone for intervention group.

Women with gestational diabetes

Eligibility Criteria

• Age: 19 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In gestational period of 24 to 34 weeks
• Diagnosed with GDM
• Aged 18 years or older
• Volunteering to participate in the study

You may not qualify if:

• Presence of a psychiatric disease
• Multiple pregnancy
• Risk of preterm labor, placenta previa or premature rupture of the membranes
• Not volunteering to participate in the study

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Nurse

Model Details: The study sample included 88 women (46 for the intervention and 42 for the control group) diagnosed with GDM. The control group received only usual care and they were followed according to the institution's diabetes follow-up protocol. In addition to the usual care, the intervention group was provided with an education program that consisted of three 45 min sessions.The women in the both group were administered the introductory information form, the Health-Promoting Lifestyle Profile II (HPLP-II), the Center for Epidemiologic Studies Depression Scale (CES-D) and the Short Form 36 Health Survey (SF-36) in the first assessment. After the education program, the HPLP-II, CES-D and SF-36 were re-administered to the intervention group four weeks after the first assessment. The HPLP-II, CES-D and SF-36 were re-administered to the both groups in the postpartum 6th week.

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 20, 2019
• Study Start: January 1, 2015
• Primary Completion: December 30, 2015
• Study Completion: June 23, 2016
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share