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Active, not recruitingNCT07880366PCOSUpdated Oct 19, 2026

The Effect of Lifestyle Program Women With PCOS

An interventional study of Lifestyle Modification Program (LMP) in Polycystic Ovary Syndrome, sponsored by Government College University Faisalabad. Active, not recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Government College University Faisalabad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2026, registered Oct 2026).
Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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, 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.

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.

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Lifestyle Modification
  • Polycystic Ovary Syndrome
  • Quality of Life
  • Perceived Stress
  • Healthy Eating Habits
  • Body Mass Index
  • Women with PCOS
03

In context

Polycystic Ovary Syndrome

975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.

This study's enrollment of 30 is below the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Government College University Faisalabad is the lead sponsor of 23 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

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
  • 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.

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Experimental Group

    Participants received a structured Lifestyle Modification Program based on the 5A's model, focusing on healthy eating, physical activity, and stress management.

    Behavioral: Lifestyle Modification Program (LMP)

  • No intervention
    Controll

    Participants continued to receive routine clinical care during the study period. Important

Interventions

  • BehavioralLifestyle Modification Program (LMP)

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

Secondary outcomes

  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.

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

07

Study locations

1 site
  • Allied Hospital II, Faisalabad, Punjab, Pakistan
    Faisalābad, Punjab Province 38000, Pakistan
08

References and documents

Individual participant data

Plan to share: 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2026 to primary completion in Sep 2026, 3 months.

Of 206 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's 3 months is below that.

Counting every sponsor, half of 221 studies reached it within 18 months; a quarter within 7 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2026
First posted
Oct 19, 2026
StartActual
Jun 1, 2026
Primary completionActual
Sep 30, 2026
CompletionEst.
Oct 13, 2026
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07880366
Lead sponsor
Government College University Faisalabad
Responsible party
Zunaira Nawaz (Principal Investigator, Government College University Faisalabad) — Principal investigator
First posted
Oct 19, 2026
Start date
Jun 1, 2026
Primary completion
Sep 30, 2026
Completion
Oct 13, 2026 (estimated)
Last update
Oct 19, 2026

Study contacts

Zunaira Naewaz, MS ( clinical Psychology)
principal investigator · Government College University Faisalabad (GCUF)
Zunaira Nawaz, MS Clinical Psychology
principal investigator · Government College University Faisalabad (GCUF)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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