Development and validation of low carbohydrate high fats adequate protein and liquid diet with time restricted meal (CHEESE Diet) for women with polycystic ovarian syndrome (PCOS)

Phase1- Qualitative co-design phase

Objective- To develop and validate a Diet education Handout (DEH) for women with PCOS, termed as the CHEESE Diet, utilising a co-design approach

Sample size- 12(6 vegetarian and 6 non vegetarian)

**Procedure-**A FGD will be conducted at the Reproductive Medicine and Surgery Department, KMC Manipal. Facilitators and a scribe will introduce themselves to participants, outlining the study’s aims, discussion rules, and confidentiality agreements. Participants will be informed about audio recording for data analysis and their role in the study. The facilitator will introduce the CHEESE DEH (Dietary Education Handout) development process, followed by administering food frequency and 24-hour diet recall questionnaires. Participants will complete two 24-hour diet recalls via telephone, spaced three days apart, following this discussion. Based on insights from the FGD and 24-hour diet recalls, an initial draft of the DEH will be prepared. Content experts will receive a content validity questionnaire to score and provide feedback. The DEH will undergo revisions until it meets standard validation scores, ensuring content validity.

Phase2- Feasibility Intervention Stage

**Objective-**To test the feasibility of the CHEESE DEH and evaluate Anthropometric measurements, lipid profile, FBS, HbA1c, and anti mullerian hormone in women with PCOS following the CHEESE diet.

**Sample size-**The total no of participants: 30 (including intervention and control group having 15 participants each)

**Procedure-**After receiving written informed consent and gathering demographic information, participants will be enrolled in the study. Each participant will receive a complete explanation of the study protocol, a Patient Information sheet (PIS) and a consent form will be obtained.

Various health parameters will be assessed during the study, including Body Mass Index (BMI), Waist Circumference (WC), body fat percentage, lean mass, lipid profile, anti-Müllerian hormone and HbA1c.

BMI will be calculated using weight (in kilograms) divided by the square of height (in meters). WC will be measured using a measuring tape. Body fat will be measured using the Body stat 1500 MDD device. Blood samples will be collected after an overnight fast during the first visit.

Participants will also complete a Food Frequency Questionnaire (FFQ). Additionally, a 24-hour diet recall will be conducted to record participants’ food intake over the previous day during the first visit. Participants will be asked to complete two more 24-hour diet recalls at home within the next three months, one on a weekday and one on a weekend day. The International Physical Activity Questionnaire (IPAQ) will assess participants’ physical activity levels over the past week during the first visit.

After completing the baseline assessment, participants will be assigned to the intervention and control group. Participants enrolled in the CHEESE Diet intervention will be provided with detailed Dietary Education Handouts (DEH) to follow at home for 12 weeks. Exercise can be one of the confounding variables therefore participants will be asked not to start any new exercise regimen and if the patient is following any exercise prior to the study should be kept constant throughout the study. Participants will be requested to share pictures of their daily food intake via WhatsApp. Adherence to the intervention will be monitored through bi-monthly telephone calls. Motivational counseling will be provided via phone as needed. Participants have the option to withdraw from the study at any time.

Immediate post intervention follow-up: Participants will undergo follow-up assessments after 3 months to measure the Body Mass Index (BMI), Waist Circumference (WC), body fat percentage, lean mass, lipid profile, anti-Mullerian hormone, fasting blood glucose and HbA1c. These assessments and follow-ups are part of the standard study protocol. Participants will complete the food frequency questionnaire and 24-hour diet recall.

Participants will be encouraged to continue the same diet for an additional 3 months. However, no adherence measures in the form of telephonic calls or WhatsApp interaction will be done during this time. Participants will be instructed not to change their physical activity levels during this time.

Short term follow-up: At the end of 6 months, Participants will undergo follow-up assessments to measure the Body Mass Index (BMI), Waist Circumference (WC), body fat percentage, lean mass, lipid profile, anti-Müllerian hormone and HbA1c. Participants will complete the food frequency questionnaire and 24-hour diet recall.

Feasibility and acceptability assessment will be done for 3months.