Assessment of Quality of Life and Psychological Factors Among Women Diagnosed With Gestational Diabetes Mellitus

Summary of Research Protocol

Title: Quality of Life and Associated Psychological Factors in Women with Gestational Diabetes Mellitus

Background:

Gestational Diabetes Mellitus (GDM) is a common metabolic disorder of pregnancy characterized by glucose intolerance first recognized during pregnancy. The prevalence of GDM is increasing globally and in India due to the rising burden of obesity and diabetes. While much research has focused on the physiological and obstetric consequences of GDM, its impact on quality of life (QoL) and psychological well-being remains less explored. Women diagnosed with GDM often experience anxiety, stress, fear regarding pregnancy outcomes, and concerns about their own and their baby's health, which may negatively affect their quality of life and adherence to treatment.

Research Gap:

Existing studies have primarily concentrated on glycemic control and pregnancy outcomes, with limited attention to the psychosocial dimensions of GDM. The relationship between quality of life and psychological factors such as anxiety, depression, stress, and social support among women with GDM has not been adequately studied, particularly in the Indian population.

Aim:

To assess the quality of life among women with Gestational Diabetes Mellitus and examine its association with psychological factors.

Objectives:

To study the quality of life in women with GDM. To compare the quality of life between pregnant women with GDM and those without GDM.

To assess associated psychological factors, including anxiety, depression, stress, and perceived social support, among women with GDM.

Methodology:

A comparative cross-sectional study will be conducted among pregnant women aged 20-40 years attending the OPD and IPD services of Christian Medical College & Hospital, Ludhiana. Women diagnosed with GDM according to DIPSI criteria (2-hour post 75 g oral glucose load blood sugar ≥140 mg/dL) will constitute the study group, while pregnant women without GDM will serve as controls.

Data regarding demographic characteristics, obstetric history, medical history, family history of diabetes, and socioeconomic status will be collected using a structured case record form. Socioeconomic status will be assessed using the Modified Kuppuswamy Scale.

Psychological assessment will include:

GAD-7 for anxiety symptoms. PHQ-9 for depressive symptoms. MSPSS for perceived social support.

Quality of life will be assessed using a validated QoL questionnaire appropriate for women with GDM.

Sample Size:

Based on previous literature, a minimum sample size of 103 participants in each group (GDM and non-GDM) has been calculated, resulting in a total sample size of 206 participants.

Statistical Analysis:

Data will be analyzed using SPSS version 26.0. Quantitative variables will be compared using Student's t-test or Mann-Whitney U test, while categorical variables will be analyzed using Chi-square or Fisher's exact test. A p-value <0.05 will be considered statistically significant.

Expected Outcome:

The study is expected to provide insights into the quality of life of women with GDM and identify psychological and social factors associated with poorer QoL. The findings may help healthcare providers develop holistic and patient-centered management strategies that address not only glycemic control but also the psychosocial needs of pregnant women with GDM.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus (GDM)

Detailed Description

Diabetes is a major public health problem in India with prevalence rates reported to be between 4.6% and 14% in urban areas, and 1.7% and 13.2% in rural areas(1).

Gestational diabetes mellitus (GDM) is a transient metabolic disorder, characterized by hyperglycemia that occurs and is first diagnosed during pregnancy, and is expected to resolve after childbirth (2).

The onset of GDM puts a heavy strain on the positive connotation of pregnancy and is accompanied by feelings of fear, anxiety, uncertainty, a sense of losing control, elevated levels of stress, a poorer perception of one's health, reduced self-worth, and impaired QoL (3). Diabetes-specific instruments disregard the fact that women suffering from GDM expect their condition as temporarily limited to their pregnancy, unlike the chronic nature of diabetes mellitus type one or type two (4).

The usage of numerous different types of questionnaires for QoL assessment leads to inconsistent study findings on this topic, resulting in heterogeneous recommendations. Accordingly, it seems reasonable to establish a solid foundation for further research by developing and validating an appropriate patient-reported outcome measure for QoL assessments in GDM. Mokhlesi et al (5) have completed important work by introducing the Persian questionnaire GDMQ-36 for the assessment of disease-specific QoL in women with GDM, which has been proven to be reliable and valid for the Iranian population.

To our knowledge, it is so far the only questionnaire worldwide tailored to the QoL of gestational diabetics that incorporates all the mentioned aspects due to the fact that it is exactly tailored to the needs as well as disease- and treatment-related challenges gestational diabetics are facing. It contains 36 questions and consists of five aspects: (1) concerns about high-risk pregnancy, (2) perceived constraints, (3) complications of GDM, (4) medication and treatment, and (5) support In managing Gestational Diabetes Mellitus (GDM) is the lack of studies that explore how a

woman's personal living conditions and biopsychosocial factors affect her adherence to treatment and overall quality of life (QoL). Aspects such as fear of hypoglycemia or concerns about fetal health can influence a woman's acceptance of treatment, even if the treatment is medically effective. Research is needed to understand how these personal and psychosocial factors impact a woman's ability to follow treatment plans and how improving QoL can enhance treatment adherence. By focusing on personalized care that takes these factors into account, Present study help create more effective and supportive treatment strategies for women with GDM.

• Study Type: Observational
• Enrollment (Estimated): 206

Contacts and Locations

• Study Contact: Name: Harsh Kishore Mr, M Pharmacy (Pharmacology); Phone Number: +91 724 864 8989; Email: harsh.42300149@lpu.in
• Study Contact Backup: Name: Harsh Kishore, M. Pharmacy (Pharmacology); Phone Number: +91 7696660211

Study Locations

• India
  • Punjab
    • Ludhiana, Punjab, India, 141008
      • Recruiting
      • Christain Medical College and Hospital
      • Contact: Rakesh Kumar; Phone Number: +91 7248648989; Email: harsh.42300149@lpu.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on all Pregnant females in age group of 20-40 years

Description

Inclusion Criteria:

• 1) All Pregnant females admitted to Christian Medical College & Hospital, Ludhiana. (OPD+IPD).

  2) Age group between 20-40 years.

  3) Females who have given consent for the study.

Exclusion Criteria:

• 1) Subjects not willing to participate.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnancy with Gestational diabetes mellitus (GDM); Pregnancy with without GDM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life as measured by the Gestational Diabetes Mellitus Quality of Life Questionnaire (GDMQ-36)	Quality of life in women with Gestational Diabetes Mellitus (GDM) will be assessed using the disease-specific GDMQ-36 questionnaire. The questionnaire consists of 36 items across 5 domains: (1) concerns about high-risk pregnancy, (2) perceived constraints, (3) complications of GDM, (4) medication and treatment, and (5) support. Total score ranges from 0 to 100, with higher scores indicating better quality of life. This will be assessed in women with GDM at baseline.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Depressive Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)	Depressive symptoms in women with GDM will be assessed using the PHQ-9 questionnaire. Each of the 9 items is scored on a Likert scale from 0 to 3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Total score ranges from 0 to 27. A score of 10 or higher indicates the presence of depressive symptoms.	Baseline
Level of Perceived Social Support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)	Perceived social support in women with GDM will be assessed using the MSPSS, a 12-item validated tool evaluating support from three sources: family, friends, and significant other. Each item is rated on a 7-point Likert scale (1 = very strongly disagree to 7 = very strongly agree). Average score ranges from 1 to 7. Social support is categorized as low (< 2), moderate (3-5), or high (> 5).	Baseline
To assess the association of serum Vitamin D with Gestational Diabetes Mellitus.	To assess the association of serum Vitamin D levels with the diagnosis of Gestational Diabetes Mellitus. Serum Vitamin D (ng/mL) levels will be measured in all participants at baseline. Vitamin D levels will be categorized as deficient (< 20 ng/mL), insufficient (20-29 ng/mL), or sufficient (≥ 30 ng/mL).	Baseline
To assess the association of serum Cortisol levels with Gestational Diabetes Mellitus.	Serum Cortisol levels will be measured in all participants at baseline. Cortisol levels will be categorized using a cut-off of 17.66 µg/L.	Baseline

Collaborators and Investigators

• Sponsor: Lovely Professional University
• Investigators: Principal Investigator: Tapasya Dhar, Christain Medical College and Hospital; Principal Investigator: Rakesh Kumar, PhD Pharmacology, School of Pharmaceutical Sciences, Lovely Professional University, Phagwara -144411, Punjab, India,

Publications and helpful links

General Publications

• Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
• Natasha K, Hussain A, Khan AK. Prevalence of depression among subjects with and without gestational diabetes mellitus in Bangladesh: a hospital based study. J Diabetes Metab Disord. 2015 Jul 28;14:64. doi: 10.1186/s40200-015-0189-3. eCollection 2015.
• Schmidt CB, Voorhorst I, van de Gaar VHW, Keukens A, Potter van Loon BJ, Snoek FJ, Honig A. Diabetes distress is associated with adverse pregnancy outcomes in women with gestational diabetes: a prospective cohort study. BMC Pregnancy Childbirth. 2019 Jul 3;19(1):223. doi: 10.1186/s12884-019-2376-6.
• Lawrence JM. Women with diabetes in pregnancy: different perceptions and expectations. Best Pract Res Clin Obstet Gynaecol. 2011 Feb;25(1):15-24. doi: 10.1016/j.bpobgyn.2010.10.003. Epub 2010 Nov 5.
• Anjana RM, Pradeepa R, Deepa M, Datta M, Sudha V, Unnikrishnan R, Bhansali A, Joshi SR, Joshi PP, Yajnik CS, Dhandhania VK, Nath LM, Das AK, Rao PV, Madhu SV, Shukla DK, Kaur T, Priya M, Nirmal E, Parvathi SJ, Subhashini S, Subashini R, Ali MK, Mohan V; ICMR-INDIAB Collaborative Study Group. Prevalence of diabetes and prediabetes (impaired fasting glucose and/or impaired glucose tolerance) in urban and rural India: phase I results of the Indian Council of Medical Research-INdia DIABetes (ICMR-INDIAB) study. Diabetologia. 2011 Dec;54(12):3022-7. doi: 10.1007/s00125-011-2291-5. Epub 2011 Sep 30.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Gestational Diabetes Mellitus (GDM)
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational
• Other Study ID Numbers: REF CMC 4525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No