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Recruiting NCT07551011

Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension

No phase Interventional Gestational Diabetes Mellitus in Pregnancy Hypertension ,Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral Modification Working (BMW) Toolkit, Routine Antenatal Care.
Who it may be relevant to
Registry conditions: Gestational Diabetes Mellitus in Pregnancy, Hypertension ,Pregnancy. Basic parameters: 15 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension: A Randomized Controlled Trial

Overview

This trial aims to evaluate the effectiveness of a Behavioral Modification Working (BMW) Toolkit in improving glycemic control and blood pressure among pregnant women diagnosed with both GDM and PIH.

Detailed description

Gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH) are major contributors to maternal and neonatal morbidity, particularly in low- and middle-income countries. Evidence suggests that lifestyle and self-care interventions focusing on diet, physical activity, and sleep may improve maternal outcomes; however, rigorously designed randomized controlled trials evaluating structured behavioral toolkits in Pakistan are scarce.

Interventions

  • Behavioral Behavioral Modification Working (BMW) Toolkit
    Structured behavioral intervention consisting of 7-8 sessions delivered by a trained health educator focusing on dietary modification, physical activity promotion, sleep hygiene, and self-care practices for pregnant women with gestational diabetes mellitus and pregnancy-induced hypertension, provided in addition to routine antenatal care.
  • Other Routine Antenatal Care
    Standard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension.

Primary outcome measures

  • Fasting Blood Glucose [Time frame: Baseline and 40 weeks gestation]
  • Blood Pressure [Time frame: Baseline and 36 weeks gestation]

Eligibility criteria

Inclusion criteria

  • Pregnant women aged 15-49 years.
  • Gestational age between 16 and 20 weeks at enrolment.
  • Diagnosed with both gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH).
  • At least one prior antenatal visit at the study site.

Exclusion criteria

  • Pre-existing diabetes mellitus or chronic hypertension prior to pregnancy.
  • Pre-existing renal disease, thyroid disease, or major hematological disorders.
  • Multiple pregnancy (e.g., twins, triplets).
  • Severe psychiatric illness.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 2 centers
  • Shaikh Zayed Hospital — Lahore
  • Sir Ganga Ram Hospital — Lahore

Publications

  • Lin C, Guan Q, Su B, Lin H, Xu Y, Wu Q, Ge L. Enhancing gestational diabetes mellitus education: a randomized controlled trial of King's theory and FMEA-PDCA integration for improved patient outcomes. BMC Pregnancy Childbirth. 2025 Oct 11;25(1):1070. doi: 10.1186/s12884-025-07932-2. PMID 41076518
  • Phudphad T, Teravecharoenchai S, Khemtong P, Suksatan W. Examining the Impact of a Behavior Modification Program on Disease Prevention Behaviors among Individuals at Risk of Diabetes: A Quasi-Experimental Investigation. Eur J Investig Health Psychol Educ. 2024 Jul 6;14(7):1969-1980. doi: 10.3390/ejihpe14070131. PMID 39056646
  • Dang NT, Le HM, Nguyen A, Glode PC, Vinter CA, Nielsen J, Nguyen KD, Gammeltoft TM, Linde DS. Self-care interventions among women with gestational diabetes mellitus in low and middle-income countries: a scoping review. Syst Rev. 2025 Feb 27;14(1):50. doi: 10.1186/s13643-025-02790-7. PMID 40016820

Identifiers

NCT: NCT07551011 · PhD-PH-E-F23-08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗