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Effects of Metformin and Theory-Based Education in Women With Polycystic Ovary Syndrome
Sponsor: Jerash Private University
Summary
Polycystic ovary syndrome (PCOS) is a common condition associated with metabolic abnormalities, including insulin resistance, impaired glucose regulation, and abnormal lipid levels. Metformin is commonly used to improve metabolic outcomes in women with PCOS, while lifestyle modification and behavioral education are important components of PCOS management. This study evaluates whether metformin, alone or combined with a theory-based behavioral educational program, is associated with changes in metabolic, vitamin B12, iron-status, erythropoietin, and hematological parameters compared with matching placebo. This is a prospective, three-arm, parallel-group randomized controlled trial conducted among women aged 18-40 years with specialist-confirmed PCOS in Ministry of Health obstetrics and gynecology clinics in Jordan. A total of 900 participants were initially randomized in a 1:1:1 ratio to receive matching placebo, metformin, or metformin combined with a theory-based behavioral educational program. The metformin groups received 1500 mg/day, administered as 500 mg three times daily, for six months. The combined intervention group additionally received five structured educational sessions addressing PCOS self-management, healthy dietary practices, physical activity, weight and waist management, metformin adherence, sleep, stress management, problem solving, and maintenance of healthy behaviors. Clinical and laboratory outcomes were assessed at baseline and after six months. The primary outcomes include changes in anthropometric, metabolic, vitamin B12, iron-status, erythropoietic, and hematological parameters. Changes in PCOS-related knowledge and lifestyle practices were also evaluated among participants receiving the combined intervention.
Official title: The Effects of Metformin Combined With a Theory-Based Educational Program on Metabolic, Vitamin B12, Iron Status, Erythropoietin, and Hematological Parameters Among Women With Polycystic Ovary Syndrome: A Three-Group Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2026-08-01
Completion Date
2026-08-01
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
MetFORMIN
Metformin was administered at a total daily dose of 1500 mg, given as 500 mg three times daily, for six months.
Matching Placebo
Matching placebo tablets identical to the metformin tablets in appearance, size, and form were administered for six months.
Theory-Based Behavioral Educational Program
A structured behavioral educational program grounded in Bandura's Self-Efficacy Theory was provided to participants in the combined intervention group. The program consisted of five structured sessions addressing PCOS self-management, healthy dietary practices, physical activity and sedentary behavior, weight and waist management, metformin adherence, metabolic health, sleep, stress management, problem solving, and maintenance of behavioral changes.
Locations (1)
Jerash University
Amman, Jordan