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Polycystic Ovary SyndromePCOSNCT07880366

The Effect of Lifestyle Program Women With PCOS

A study testing Lifestyle Modification Program (LMP) in people with Polycystic Ovary Syndrome, run by Government College University Faisalabad at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Polycystic Ovary Syndrome (PCOS) is a common hormonal condition affecting women of reproductive age. In addition to physical symptoms such as irregular menstruation, hormonal changes, and changes in body weight, women with PCOS may experience increased stress, difficulties in maintaining healthy lifestyle behaviors… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Lifestyle Modification Program (LMP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
1 Jun 2026to 13 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 3.3.1 Inclusion Criteria
  • To be eligible for participation, individuals must meet the following criteria at the time of enrollment:
  • Aged between 18 and 45 years.
  • Formally diagnosed with PCOS based on clinical assessments.
  • Unmarried status.
  • Married, having no children
Show all 13Show fewer
  • Free from co-occurring major chronic somatic diseases (such as cancer or type 1/type 2 diabetes).
  • Able and willing to sessional interventions.
  • Willing and capable of providing written, voluntary informed consent. 3.3.2 Exclusion Criteria
  • Potential participants were excluded if they meet any of the following conditions:
  • Documented clinical diagnosis of diabetes (pre-existing or requiring active pharmacological management).
  • Currently receiving any other structured psychological therapy or specialized pharmacological weight-loss intervention that could confound the study outcomes.
  • Severe physical or physical health complications that prevent regular attendance or active participation in the low-GI diet and exercise routines.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Allied Hospital II, Faisalabad, Punjab, Pakistan

    Faisalābad, Punjab Province, 38000

Other trials in Pakistan

About this study

Official title: The Effect of Lifestyle Program on Quality of Life Among Women With PCOS

Polycystic Ovary Syndrome (PCOS) is a common hormonal condition affecting women of reproductive age. In addition to physical symptoms such as irregular menstruation, hormonal changes, and changes in body weight, women with PCOS may experience increased stress, difficulties in maintaining healthy lifestyle behaviors, and reduced quality of life. Lifestyle behaviors, including healthy eating, physical activity, and stress management, may play an important role in improving overall well-being among women with PCOS.

This study examined the effect of a structured Lifestyle Modification Program on stress, healthy eating habits, health-promoting lifestyle behaviors, and PCOS-related quality of life among women diagnosed with PCOS. The program was based on the 5A's model: Assess, Advise, Agree, Assist, and Arrange, and was culturally adapted for women with PCOS.

Read more

A total of 30 women with PCOS participated in the study. Participants were recruited from the Gynecology Department of Allied Hospital II, Faisalabad, and were placed into an experimental group (n = 15) or a control group (n = 15). The experimental group participated in a structured lifestyle modification program delivered through four sessions over two weeks. The program focused on healthy dietary practices, physical activity, stress management, and strategies for maintaining healthy lifestyle behaviors. The control group continued with routine clinical care.

Participants completed assessments before and after the intervention. Measures assessed perceived stress, healthy eating habits, health-promoting lifestyle behaviors, and PCOS-related quality of life.

The study was conducted to determine whether a structured lifestyle modification program could contribute to improvements in psychological well-being, healthy lifestyle behaviors, and quality of life among women with PCOS. The findings may help inform the integration of psychological and lifestyle-based interventions into the care of women with PCOS.

Read the detailed description

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder among women of reproductive age. It is associated with hormonal and metabolic changes, including irregular menstruation, hyperandrogenism, insulin resistance, and changes in body weight. These physical and hormonal manifestations may also affect psychological well-being and quality of life. Women with PCOS may experience increased stress and difficulties in maintaining healthy lifestyle behaviors, which can further affect their daily functioning and overall quality of life.

Lifestyle modification involving healthy dietary practices, regular physical activity, and stress management is considered an important component of PCOS management. However, interventions for PCOS have often emphasized medical and biological aspects, while psychological well-being and sustainable lifestyle behaviors may receive comparatively less attention. The present study therefore examined a structured lifestyle modification program designed to address both lifestyle and psychological factors among women with PCOS.

The study aimed to examine the effect of a structured Lifestyle Modification Program based on the 5A's model (Assess, Advise, Agree, Assist, and Arrange) among women diagnosed with PCOS. The program was culturally adapted to address the lifestyle and psychological needs of the participating women.

Women diagnosed with PCOS who met the eligibility criteria were recruited from the Gynecology Department of Allied Hospital II, Faisalabad. The final sample consisted of 30 women, with 15 participants in the experimental group and 15 participants in the control group. Participants were women aged 18-40 years who had a clinical diagnosis of PCOS and were willing to participate in the study. Women who were pregnant or did not meet the study eligibility requirements were excluded.

The experimental group received a structured Lifestyle Modification Program consisting of four sessions delivered over a two-week period. The intervention addressed healthy eating, physical activity, stress management, and strategies for maintaining lifestyle changes. The 5A's framework provided a structured approach for assessing participants' needs, providing relevant advice, agreeing on achievable lifestyle goals, assisting participants in addressing barriers to change, and arranging strategies for maintaining healthy behaviors.

The intervention included psychoeducation regarding PCOS and healthy lifestyle practices, guidance regarding dietary choices and physical activity, stress-management techniques, and behavioral strategies to support adherence to healthier routines. Participants were encouraged to monitor their lifestyle behaviors and identify barriers that could interfere with maintaining healthy habits. Strategies were discussed to help participants manage common difficulties and maintain behavioral changes after the intervention.

The control group continued to receive routine clinical care during the study period. Following completion of the post-intervention assessment, participants in the control group were offered the lifestyle modification materials.

Participants completed assessments before and after the intervention. The assessment battery included measures of perceived stress, healthy eating habits, health-promoting lifestyle behaviors, and PCOS-related quality of life. The Perceived Stress Scale (PSS-10-U) was used to assess perceived stress, the Brief Healthy Eating Habits Scale-Short Form was used to assess healthy eating habits, the Health-Promoting Lifestyle Profile II was used to assess health-promoting lifestyle behaviors, and the PCOS Quality of Life measure was used to assess quality of life related to PCOS.

The study used a randomized clinical trial design to examine changes in outcomes following the Lifestyle Modification Program. Data were analyzed using appropriate statistical procedures, including descriptive statistics, tests of baseline group differences, and mixed repeated-measures analyses to examine changes over time and differences between groups.

The study focused on whether participation in the Lifestyle Modification Program was associated with changes in perceived stress, healthy eating habits, health-promoting lifestyle behaviors, and PCOS-related quality of life. The findings may provide useful information for psychologists, healthcare professionals, and other providers working with women with PCOS by highlighting the potential role of structured lifestyle and psychological support alongside routine clinical care.

Being tested
Lifestyle Modification Program (LMP)
Keywords
Lifestyle Modification, Polycystic Ovary Syndrome, Quality of Life, Perceived Stress, Healthy Eating Habits, Body Mass Index, Women with PCOS
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle Modification Program (LMP)Behavioural

    A structured 2-week lifestyle modification program consisting of four sessions focused on healthy eating, physical activity, stress management, self-monitoring, overcoming lifestyle barriers, and relapse-prevention planning for women with PCOS.

Study groups in NCT07880366
Study groupRoleWhat they receive
Experimental GroupExperimentalParticipants received a structured Lifestyle Modification Program based on the 5A's model, focusing on healthy eating, physical activity, and stress management.
Receives: Behavioral: Lifestyle Modification Program (LMP)
ControllNo interventionParticipants continued to receive routine clinical care during the study period. Important

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Stress

    Perceived stress will be assessed using the Perceived Stress Scale (PSS-10-U). The total scale score will be calculated according to the instrument's scoring instructions. Changes in perceived stress will be evaluated by comparing baseline and post-intervention scores.

    Measured: Baseline (pre-intervention) and immediately after completion of the 2-week intervention (post-intervention).

  2. Health-Promoting Lifestyle Profile-II (HPLP-II).

    Health-promoting lifestyle behaviors will be assessed using the Health-Promoting Lifestyle Profile II (HPLP-II). The total score will be calculated according to the instrument's scoring instructions. Changes in health-promoting lifestyle behaviors will be evaluated by comparing baseline and post-intervention scores.

    Measured: Baseline (pre-intervention) and immediately after completion of the 2-week intervention (post-intervention).

  3. Change in Healthy Eating Habits

    Healthy eating habits will be assessed using the Brief Healthy Eating Habits Scale (BHEHS-6B). The total score will be calculated according to the instrument's scoring instructions. Changes in healthy eating habits will be evaluated by comparing baseline and post-intervention scores.

    Measured: Baseline (pre-intervention) and immediately after completion of the 2-week intervention (post-intervention).

  4. PCOS-Related Quality of Life

    PCOS-related quality of life will be assessed using the 26-item PCOS Quality of Life Questionnaire (PCOSQ-26). The total score will be calculated according to the instrument's scoring instructions. Changes in PCOS-related quality of life will be evaluated by comparing baseline and post-intervention scores.

    Measured: Baseline (pre-intervention) and immediately after completion of the 2-week intervention (post-intervention).

Secondary outcomes (1)
  1. Change in Body Mass Index (BMI)

    Body mass index (BMI) will be calculated by dividing body weight in kilograms by the square of height in meters (BMI = weight in kg / height in m²). BMI will be assessed at baseline and post-intervention to evaluate changes following the lifestyle modification program. Weight and height will be combined to calculate a single BMI value, expressed in kg/m².

    Measured: Baseline (pre-intervention) and immediately after completion of the 2-week intervention (post-intervention).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2026
  2. Study start1 Jun 2026
  3. Primary completion30 Sep 2026
  4. Study completion13 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were assigned to either an experimental group or a control group. The experimental group received a structured Lifestyle Modification Program based on the 5A's model, focusing on healthy eating, physical activity, and stress management, while the control group received routine clinical care. Outcomes were assessed before and after the intervention and compared between the two groups.
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07880366
Sponsor's protocol ID
zunairanawaz126@gmail.com
Acronym
PCOS
Status last verified
Oct 2026
First submitted
1 Oct 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because the data contain participant-level information and cannot be made publicly available while maintaining participant confidentiality and privacy.

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Modification Program (LMP) in people with Polycystic Ovary Syndrome, run by Government College University Faisalabad at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Stress (time frame: Baseline (pre-intervention) and immediately after completion of the 2-week intervention (post-intervention).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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