Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| McGill University | OTHER |
| Netherlands Open University | OTHER |
| Massachusetts General Hospital | OTHER |
| Ekhagastiftelsen |
Not provided
Not provided
Not provided
Not provided
This study will assess the feasibility and acceptability of a combination intervention including dietary counselling and omega-3 fatty acid supplementation among women with generalized anxiety disorder. It will be randomized and wait-list controlled with 25 participants completing the 12-week intervention immediately and the other 25 participants completing the intervention after a 12-week wait period.
Generalized Anxiety Disorder (GAD) is a common mental health disorder involving high levels of worry or tension. The symptoms are persistent and distressing and interfere with an individual's functioning and quality of life. Clinical evidence suggests that nutritional interventions, based on the Mediterranean diet and omega-3 fatty acid supplementation improve the symptoms of depression. To date, the effect of diet change interventions on anxiety symptoms has not been studied in trials involving people with diagnosed anxiety disorders. The primary objective of this study is to test the feasibility and acceptability of a dietary counselling and omega-3 fatty acid supplementation intervention delivered to adult women with GAD. The secondary objectives include measuring changes in anxiety symptom severity, measuring changes in quality of life, measuring changes in biomarkers and evaluation of the components of the program.
This study is a randomized, wait-list controlled pilot trial delivering a 12-week, dietary counselling intervention and omega-3 supplementation to 50 adult women with GAD. Participant will complete seven individual counselling sessions which include nutrition education, personalized recommendations, mindful eating techniques, motivational interviewing, and goal setting. They will be provided with recipes, instructional videos, and food items. Questionnaires and blood work will be completed at baseline, after the wait period (for those in the wait-list group) and after the intervention. The questionnaires will measure changes in anxiety symptom severity, quality of life, diet quality, mindful eating behaviours, and self-efficacy and lab tests will measure changes in biomarkers of nutritional status. All participants will be asked to complete a brief satisfaction survey concerning the participant's level of satisfaction with the program, the aspects which were helpful or unhelpful, and opportunities for improvement. A sub-sample will be recruited to participate in a brief focus group in order to obtain more detailed qualitative responses about the participant experience and participant satisfaction. Additional information will be collected to characterize study participants including demographic information, body mass index, physical activity and food security.
Results from this study will lay the foundation for future large-scale studies in this area and may provide preliminary evidence of the role of diet counselling and omega-3 supplementation in the management of GAD.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Start | Experimental | Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation |
|
| Waitlist Control | No Intervention | Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Counselling combined with Omega-3 Supplementation | Combination Product | Dietary Counselling: Seven, bi-weekly counselling sessions over 12-weeks conducted by a licensed Naturopathic Doctor. Each session will be 45-60 minutes in length. The recommendations will be based on the Mediterranean diet and the results of a recent scoping review which summarized the research related to diet and anxiety. The intervention will include motivational interviewing, mindful eating techniques, goal setting and action planning. A range of resources related to meal planning, recipes, cooking education, shopping lists and tracking sheets will be provided in an individualized manner. Dietary Supplement: AquaOmega High EPA Omega-3 capsules will be taken at a dose of four capsules, once daily (containing a total of 3456 mg of omega-3 fatty acids: 2659mg of Eicosapentaenoic acid (EPA), 532mg of docosahexaenoic acid (DHA), and 800IU of Vitamin D), with a meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Participant Recruitment and Intervention Delivery | Feasibility will be assessed by measuring the time to recruit and enrol 50 participants. Additionally, we will compare the intervention protocol with the intervention activities delivered. | 8 months |
| Acceptability of the Intervention by Study Participants | Acceptability will be assessed by measuring the number of diet counselling sessions completed. Additionally, participants will be asked to complete a brief satisfaction survey concerning the participant's level of satisfaction with the program, the aspects which were helpful or unhelpful, and opportunities for improvement. A sub-sample will be recruited to participate in a brief focus group in order to obtain more detailed qualitative responses about the participant experience and participant satisfaction. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Symptom Severity: The Beck Anxiety Inventory | The Beck Anxiety Inventory is a validated 21-item self-report inventory for measuring the severity of anxiety in participants with psychiatric illness. Answers to each item are given a score of 0 (not at all), 1 (mild), 2 (moderate) or 3 (severely), total scores range from 0 to 63 (minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63)). The Beck Anxiety Inventory will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants who identify as women are eligible to participate
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Monique Aucoin, ND MSc | Canadian College of Naturopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian College of Naturopathic Medicine | Toronto | Ontario | M2K 1E2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39316026 | Derived | Aucoin M, LaChance L, van der Wurff I, McLaren M, Monteiro S, Miller S, Jenkins A, Sabri E, Cooley K. Dietary counseling plus omega-3 supplementation in the treatment of generalized anxiety disorder: results of a randomized wait-list controlled pilot trial (the 'EASe-GAD Trial'). Nutr Neurosci. 2025 Jun;28(6):635-648. doi: 10.1080/1028415X.2024.2403901. Epub 2024 Sep 24. | |
| 37950301 |
| Label | URL |
|---|---|
| Study Protocol | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Start | Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation Dietary Counselling combined with Omega-3 Supplementation: Dietary Counselling: Seven, bi-weekly counselling sessions over 12-weeks conducted by a licensed Naturopathic Doctor. Each session will be 45-60 minutes in length. The recommendations will be based on the Mediterranean diet and the results of a recent scoping review which summarized the research related to diet and anxiety. The intervention will include motivational interviewing, mindful eating techniques, goal setting and action planning. A range of resources related to meal planning, recipes, cooking education, shopping lists and tracking sheets will be provided in an individualized manner. Dietary Supplement: AquaOmega High EPA Omega-3 capsules will be taken at a dose of four capsules, once daily (containing a total of 3456 mg of omega-3 fatty acids: 2659mg of Eicosapentaenoic acid (EPA), 532mg of docosahexaenoic acid (DHA), and 800IU of Vitamin D), with a meal. |
| FG001 | Waitlist Control | Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Start | began intervention immediately |
| BG001 | Waitlist | completed 12 week wait and then began intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Participant Recruitment and Intervention Delivery | Feasibility will be assessed by measuring the time to recruit and enrol 50 participants. Additionally, we will compare the intervention protocol with the intervention activities delivered. | 443 individuals contacted the study in 8 months. Of these, 50 met criteria for enrollment | Posted | Number | months | 8 months |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Start | Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation Dietary Counselling combined with Omega-3 Supplementation: Dietary Counselling: Seven, bi-weekly counselling sessions over 12-weeks conducted by a licensed Naturopathic Doctor. Each session will be 45-60 minutes in length. The recommendations will be based on the Mediterranean diet and the results of a recent scoping review which summarized the research related to diet and anxiety. The intervention will include motivational interviewing, mindful eating techniques, goal setting and action planning. A range of resources related to meal planning, recipes, cooking education, shopping lists and tracking sheets will be provided in an individualized manner. Dietary Supplement: AquaOmega High EPA Omega-3 capsules will be taken at a dose of four capsules, once daily (containing a total of 3456 mg of omega-3 fatty acids: 2659mg of Eicosapentaenoic acid (EPA), 532mg of docosahexaenoic acid (DHA), and 800IU of Vitamin D), with a meal. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI symptoms | Gastrointestinal disorders | Systematic Assessment | belching (n=5), diarrhea (n=5), gastroesophageal reflux (n=3), bloating (n=3), nausea (n=2) and constipation (n=1) |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monique Aucoin | Canadian College of Naturopathic Medicine | 416 498 1255 | 223 | maucoin@ccnm.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2023 | Mar 18, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2023 | Mar 18, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| OTHER |
| AquaOmega | UNKNOWN |
| Lipid Analytical Laboratories Inc | UNKNOWN |
| Mitacs | INDUSTRY |
This study will be wait-list controlled. Participants will be randomized to one of two groups. One group will begin the intervention immediately. The other will wait 12 weeks and then complete the intervention.
Not provided
Not provided
Collection of height and weight data will be completed by an individual blind to participant allocation. The statistician completing data analysis will be blind to allocation.
|
| 12 weeks |
| Diet Quality: MEDI-LITE Questionnaire | MEDI-LITE is a validated questionnaire that measures daily and weekly consumption of food typical and non-typical to the Mediterranean diet. Typical Mediterranean diet foods are scored 2 for high consumption, 1 more moderate and 0 for low. Non-typical Mediterranean diet foods are scored 2 for low consumption, 1 for moderate and 0 for high. Scores range from 0 (low consumption) to 18 (high consumption). The MEDI-LITE questionnaire will be completed to assess adherence to the Mediterranean diet at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| Quality of Life: PROMIS-29 v2.1 | The PROMIS-29 is a validated scale using 4 items scored on a 1-5 scale on intensity to assess 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities and pain interference). Higher score equals more of the concept being measured (e.g., more Fatigue, more Physical Function). PROMIS-29 will be used to assess quality of life at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| Mindful Eating Behaviour: Mindful Eating Questionnaire | The MEQ is a 28-item scale that measures five factors associated with mindful eating (emotional responses, distraction, external cues, awareness and disinhibition). The questionnaire will be used to measure behaviour change and qualitatively assess the acceptability of the intervention. Each item is scored on a 1-4 scale, higher scores signify more mindful eating. The scores are added together and divided by the number of items answered to get a total summary score. The minimum score is 1 and the maximum score is 4. The MEQ will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| Self Efficacy: General Self-Efficacy Scale | The GSE is a 10-item validated questionnaire that measures an individual's belief in their ability to overcome and respond to difficult scenarios. Answers to each item are given a score of 0 (not at all true), 1 (barely true), 3 (moderately true) or 4 (exactly true), higher scores correlate to greater self-efficacy. The minimum score is 10 and the maximum score is 40. The GSE will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| OmegaScore | Summed EPA, DHA and DPA as a percentage of total fatty acids in whole blood as a measure of omega-3 status. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| Fasting Cholesterol Panel | Measures of serum cholesterol including LDL, HDL, triglycerides and total cholesterol. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| Hemoglobin A1c | Measure of the average blood sugar in the past 3 months. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| Serum Vitamin C | Measure of serum levels of vitamin C as an objective marker for fruit and vegetable intake. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| Serum Beta-carotene | Measure of serum levels of beta-carotene as an objective marker for fruit and vegetable. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| C-reactive Protein | CRP will be used to measure inflammation levels. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| HOMA-IR | Homeostatic Model Assessment of Insulin Resistance, calculated using fasting insulin and fasting glucose. Formula: fasting glucose (mg/dL) X fasting insulin (mU/L) / 405. A higher value suggests more insulin resistance. These blood tests and calculation will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | 12 weeks |
| Derived |
| Aucoin M, LaChance L, van der Wurff I, Miller S, Naidoo U, Jenkins A, Cooley K. Dietary counselling plus omega-3 supplementation in the treatment of generalized anxiety disorder: protocol for a randomized wait-list controlled pilot trial (the "EASe-GAD Trial"). Pilot Feasibility Stud. 2023 Nov 10;9(1):186. doi: 10.1186/s40814-023-01414-y. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Baseline Beck Anxiety Inventory Score | Mean | Standard Deviation | units on a scale |
|
| OG001 | Waitlist Control | Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm. |
|
|
| Primary | Acceptability of the Intervention by Study Participants | Acceptability will be assessed by measuring the number of diet counselling sessions completed. Additionally, participants will be asked to complete a brief satisfaction survey concerning the participant's level of satisfaction with the program, the aspects which were helpful or unhelpful, and opportunities for improvement. A sub-sample will be recruited to participate in a brief focus group in order to obtain more detailed qualitative responses about the participant experience and participant satisfaction. | Posted | Mean | Standard Deviation | number of sessions attended | 12 weeks |
|
|
|
| Secondary | Anxiety Symptom Severity: The Beck Anxiety Inventory | The Beck Anxiety Inventory is a validated 21-item self-report inventory for measuring the severity of anxiety in participants with psychiatric illness. Answers to each item are given a score of 0 (not at all), 1 (mild), 2 (moderate) or 3 (severely), total scores range from 0 to 63 (minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63)). The Beck Anxiety Inventory will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | Baseline questionnaires were completed by 24 participants in the immediate start group and 25 participants in the waitlist group. 23 participants in each group completed the 12 week questionnaires. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
| Secondary | Diet Quality: MEDI-LITE Questionnaire | MEDI-LITE is a validated questionnaire that measures daily and weekly consumption of food typical and non-typical to the Mediterranean diet. Typical Mediterranean diet foods are scored 2 for high consumption, 1 more moderate and 0 for low. Non-typical Mediterranean diet foods are scored 2 for low consumption, 1 for moderate and 0 for high. Scores range from 0 (low consumption) to 18 (high consumption). The MEDI-LITE questionnaire will be completed to assess adherence to the Mediterranean diet at baseline, after the wait period (for those in the waitlist group) and after the intervention. | Baseline questionnaires were completed by 24 participants in the immediate start group and 25 participants in the waitlist group. 23 participants in each group completed the 12 week questionnaires. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
|
|
|
| Secondary | Quality of Life: PROMIS-29 v2.1 | The PROMIS-29 is a validated scale using 4 items scored on a 1-5 scale on intensity to assess 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities and pain interference). Higher score equals more of the concept being measured (e.g., more Fatigue, more Physical Function). PROMIS-29 will be used to assess quality of life at baseline, after the wait period (for those in the waitlist group) and after the intervention. | Baseline questionnaires were completed by 24 participants in the immediate start group and 25 participants in the waitlist group. 23 participants in each group completed the 12 week questionnaires. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
|
|
|
| Secondary | Mindful Eating Behaviour: Mindful Eating Questionnaire | The MEQ is a 28-item scale that measures five factors associated with mindful eating (emotional responses, distraction, external cues, awareness and disinhibition). The questionnaire will be used to measure behaviour change and qualitatively assess the acceptability of the intervention. Each item is scored on a 1-4 scale, higher scores signify more mindful eating. The scores are added together and divided by the number of items answered to get a total summary score. The minimum score is 1 and the maximum score is 4. The MEQ will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | Baseline questionnaires were completed by 24 participants in the immediate start group and 25 participants in the waitlist group. 23 participants in each group completed the 12 week questionnaires. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
| Secondary | Self Efficacy: General Self-Efficacy Scale | The GSE is a 10-item validated questionnaire that measures an individual's belief in their ability to overcome and respond to difficult scenarios. Answers to each item are given a score of 0 (not at all true), 1 (barely true), 3 (moderately true) or 4 (exactly true), higher scores correlate to greater self-efficacy. The minimum score is 10 and the maximum score is 40. The GSE will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | Baseline questionnaires were completed by 24 participants in the immediate start group and 25 participants in the waitlist group. 23 participants in each group completed the 12 week questionnaires. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
| Secondary | OmegaScore | Summed EPA, DHA and DPA as a percentage of total fatty acids in whole blood as a measure of omega-3 status. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | all 50 participants assessed at baseline. 21 and 23 assessed at 12 weeks | Posted | Mean | Standard Deviation | percentage | 12 weeks |
|
|
|
| Secondary | Fasting Cholesterol Panel | Measures of serum cholesterol including LDL, HDL, triglycerides and total cholesterol. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group | Posted | Mean | 95% Confidence Interval | mmol/L | 12 weeks |
|
|
|
| Secondary | Hemoglobin A1c | Measure of the average blood sugar in the past 3 months. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group | Posted | Mean | 95% Confidence Interval | percentage | 12 weeks |
|
|
|
| Secondary | Serum Vitamin C | Measure of serum levels of vitamin C as an objective marker for fruit and vegetable intake. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group | Posted | Mean | 95% Confidence Interval | umol/L | 12 weeks |
|
|
|
| Secondary | Serum Beta-carotene | Measure of serum levels of beta-carotene as an objective marker for fruit and vegetable. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group | Posted | Mean | 95% Confidence Interval | umol/L | 12 weeks |
|
|
|
| Secondary | C-reactive Protein | CRP will be used to measure inflammation levels. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group | Posted | Mean | 95% Confidence Interval | mg/L | 12 weeks |
|
|
|
| Secondary | HOMA-IR | Homeostatic Model Assessment of Insulin Resistance, calculated using fasting insulin and fasting glucose. Formula: fasting glucose (mg/dL) X fasting insulin (mU/L) / 405. A higher value suggests more insulin resistance. These blood tests and calculation will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention. | at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group | Posted | Mean | 95% Confidence Interval | HOMA-IR index | 12 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 21 |
| 25 |
| EG001 | Waitlist Control | Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm. | 0 | 25 | 0 | 25 | 0 | 25 |
|
| heart palpitations | Cardiac disorders | Systematic Assessment |
|
| pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| 12 weeks |
|
|
| 12 Weeks |
|
|
| physical, 12 weeks |
|
|
| anxiety, baseline |
|
|
| anxiety, 12 weeks |
|
|
| depression, baseline |
|
|
| depression, 12 weeks |
|
|
| fatigue, baseline |
|
|
| fatigue, 12 weeks |
|
|
| social, baseline |
|
|
| social, 12 weeks |
|
|
| pain, baseline |
|
|
| pain, 12 weeks |
|
|
| MEQ, 12 weeks |
|
|
| GSE, 12 weeks |
|
|
| week 12 |
|
|
| triglycerides, week 12 |
|
|
| Total cholesterol, baseline |
|
|
| Total cholesterol, week 12 |
|
|
| LDL, baseline |
|
|
| LDL, week 12 |
|
|
| HDL, baseline |
|
|
| HDL, week 12 |
|
|
| 12 weeks |
|
|
| week 12 |
|
|
| week 12 |
|
|
| week 12 |
|
|
| 12 weeks |
|
|