Generalized Anxiety Disorder
Conditions
Keywords
anxiety, generalized anxiety disorder, nutrition, diet, omega-3, lifestyle
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTDietary 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.
Sponsors
McGill University
Netherlands Open University
Massachusetts General Hospital
Ekhagastiftelsen
AquaOmega
Lipid Analytical Laboratories Inc
Mitacs
The Canadian College of Naturopathic Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A person aged 18-65 years who currently identifies as a woman. * Primary diagnosis of generalized anxiety disorder based on a clinical interview with a psychiatrist using the DSM-5 criteria. * Moderate to severe anxiety as defined as a Beck Anxiety Inventory score of 22 or higher. * Low quality diet as defined as a score of 8.5 or less on the MEDI-LITE tool. * All psychiatric medication, psychotherapy and natural health products stable for the past four weeks. * Established therapeutic relationship with a family doctor, psychiatrist, or clinical psychologist as their primary source of mental health care. * Ability to swallow capsules. * Ability to read in English and provide informed consent
Exclusion criteria
* Currently meets DSM-5 criteria for obsessive-compulsive disorder, bipolar disorder, a psychotic disorder, an eating disorder, or substance use disorder based on clinical interview with a psychiatrist. * Current high level of suicidality assessed by trial psychiatrist using the Columbia Suicide Severity Scale. * Starting or changing the dose of a psychiatric medication, psychotherapy, or natural health products in the past four weeks. * Severe food allergies, intolerances or aversions that would prevent the individual from modifying their diet (includes aversion to bovine gelatin which is a component of the fish oil supplement). * Current participation in a program, research study or treatment plan involving diet or lifestyle modification. * Baseline Omega Score of \>5% (suggesting adequacy of omega-3 fatty acids). * Supplementation of greater than 4000IU of vitamin D daily for at least one month in the previous six months. * Allergy to fish or any of the non-medicinal ingredients in the study product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Participant Recruitment and Intervention Delivery | 8 months | 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. |
| Acceptability of the Intervention by Study Participants | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Symptom Severity: The Beck Anxiety Inventory | 12 weeks | 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. |
| Diet Quality: MEDI-LITE Questionnaire | 12 weeks | 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. |
| Quality of Life: PROMIS-29 v2.1 | 12 weeks | 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. |
| Mindful Eating Behaviour: Mindful Eating Questionnaire | 12 weeks | 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. |
| Self Efficacy: General Self-Efficacy Scale | 12 weeks | 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. |
| OmegaScore | 12 weeks | 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. |
| Fasting Cholesterol Panel | 12 weeks | 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. |
| Hemoglobin A1c | 12 weeks | 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. |
| Serum Vitamin C | 12 weeks | 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. |
| Serum Beta-carotene | 12 weeks | 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. |
| C-reactive Protein | 12 weeks | 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. |
| HOMA-IR | 12 weeks | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Start began intervention immediately | 24 |
| Waitlist completed 12 week wait and then began intervention | 25 |
| Total | 49 |
Baseline characteristics
| Characteristic | Immediate Start | Waitlist | Total |
|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 14 | 35 years STANDARD_DEVIATION 10 | 37 years STANDARD_DEVIATION 12 |
| Baseline Beck Anxiety Inventory Score | 26.2 units on a scale STANDARD_DEVIATION 8.17 | 29.3 units on a scale STANDARD_DEVIATION 11.71 | 27.8 units on a scale STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized Another race | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Do not know | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized East/Southeast Asian | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized First Nations/Indigenous/Metis | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Latino | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Middle Eastern | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized South Asian | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Female | 24 Participants | 25 Participants | 49 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 21 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start | Acceptability of the Intervention by Study Participants | 6.4 number of sessions attended | Standard Deviation 1.5 |
| Waitlist Control | Acceptability of the Intervention by Study Participants | 6.4 number of sessions attended | Standard Deviation 1.9 |
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.
Time frame: 8 months
Population: 443 individuals contacted the study in 8 months. Of these, 50 met criteria for enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Start | Feasibility of Participant Recruitment and Intervention Delivery | 8 months |
| Waitlist Control | Feasibility of Participant Recruitment and Intervention Delivery | 8 months |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | Anxiety Symptom Severity: The Beck Anxiety Inventory | Baseline | 26.2 units on a scale |
| Immediate Start | Anxiety Symptom Severity: The Beck Anxiety Inventory | 12 weeks | 11.0 units on a scale |
| Waitlist Control | Anxiety Symptom Severity: The Beck Anxiety Inventory | Baseline | 29.3 units on a scale |
| Waitlist Control | Anxiety Symptom Severity: The Beck Anxiety Inventory | 12 weeks | 26.8 units on a scale |
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.
Time frame: 12 weeks
Population: at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | C-reactive Protein | baseline | 3.11 mg/L |
| Immediate Start | C-reactive Protein | week 12 | 4.06 mg/L |
| Waitlist Control | C-reactive Protein | baseline | 6.60 mg/L |
| Waitlist Control | C-reactive Protein | week 12 | 7.49 mg/L |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | Diet Quality: MEDI-LITE Questionnaire | Baseline | 7.2 score on a scale |
| Immediate Start | Diet Quality: MEDI-LITE Questionnaire | 12 Weeks | 10.5 score on a scale |
| Waitlist Control | Diet Quality: MEDI-LITE Questionnaire | Baseline | 7.1 score on a scale |
| Waitlist Control | Diet Quality: MEDI-LITE Questionnaire | 12 Weeks | 6.9 score on a scale |
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.
Time frame: 12 weeks
Population: at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | Fasting Cholesterol Panel | triglycerides, baseline | 1.13 mmol/L |
| Immediate Start | Fasting Cholesterol Panel | triglycerides, week 12 | 0.88 mmol/L |
| Immediate Start | Fasting Cholesterol Panel | Total cholesterol, baseline | 4.72 mmol/L |
| Immediate Start | Fasting Cholesterol Panel | Total cholesterol, week 12 | 4.62 mmol/L |
| Immediate Start | Fasting Cholesterol Panel | LDL, baseline | 2.63 mmol/L |
| Immediate Start | Fasting Cholesterol Panel | LDL, week 12 | 2.67 mmol/L |
| Immediate Start | Fasting Cholesterol Panel | HDL, baseline | 1.58 mmol/L |
| Immediate Start | Fasting Cholesterol Panel | HDL, week 12 | 1.55 mmol/L |
| Waitlist Control | Fasting Cholesterol Panel | HDL, week 12 | 1.49 mmol/L |
| Waitlist Control | Fasting Cholesterol Panel | triglycerides, baseline | 1.02 mmol/L |
| Waitlist Control | Fasting Cholesterol Panel | LDL, baseline | 2.84 mmol/L |
| Waitlist Control | Fasting Cholesterol Panel | triglycerides, week 12 | 0.88 mmol/L |
| Waitlist Control | Fasting Cholesterol Panel | HDL, baseline | 1.50 mmol/L |
| Waitlist Control | Fasting Cholesterol Panel | Total cholesterol, baseline | 4.80 mmol/L |
| Waitlist Control | Fasting Cholesterol Panel | LDL, week 12 | 2.86 mmol/L |
| Waitlist Control | Fasting Cholesterol Panel | Total cholesterol, week 12 | 4.75 mmol/L |
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.
Time frame: 12 weeks
Population: at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | Hemoglobin A1c | baseline | 5.35 percentage |
| Immediate Start | Hemoglobin A1c | 12 weeks | 5.36 percentage |
| Waitlist Control | Hemoglobin A1c | baseline | 5.52 percentage |
| Waitlist Control | Hemoglobin A1c | 12 weeks | 5.57 percentage |
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.
Time frame: 12 weeks
Population: at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | HOMA-IR | baseline | 2.94 HOMA-IR index |
| Immediate Start | HOMA-IR | 12 weeks | 2.92 HOMA-IR index |
| Waitlist Control | HOMA-IR | baseline | 4.05 HOMA-IR index |
| Waitlist Control | HOMA-IR | 12 weeks | 4.81 HOMA-IR index |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | Mindful Eating Behaviour: Mindful Eating Questionnaire | MEQ, 12 weeks | 2.88 units on a scale |
| Immediate Start | Mindful Eating Behaviour: Mindful Eating Questionnaire | MEQ, baseline | 2.5 units on a scale |
| Waitlist Control | Mindful Eating Behaviour: Mindful Eating Questionnaire | MEQ, baseline | 2.6 units on a scale |
| Waitlist Control | Mindful Eating Behaviour: Mindful Eating Questionnaire | MEQ, 12 weeks | 2.5 units on a scale |
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.
Time frame: 12 weeks
Population: all 50 participants assessed at baseline. 21 and 23 assessed at 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Start | OmegaScore | baseline | 3.58 percentage | Standard Deviation 0.74 |
| Immediate Start | OmegaScore | week 12 | 7.18 percentage | Standard Deviation 2.12 |
| Waitlist Control | OmegaScore | baseline | 3.43 percentage | Standard Deviation 0.5 |
| Waitlist Control | OmegaScore | week 12 | 3.47 percentage | Standard Deviation 0.92 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | physical, baseline | 4.54 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | physical, 12 weeks | 4.79 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | anxiety, baseline | 3.42 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | anxiety, 12 weeks | 2.16 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | depression, baseline | 2.59 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | depression, 12 weeks | 1.72 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | fatigue, baseline | 3.78 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | fatigue, 12 weeks | 2.75 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | social, baseline | 2.83 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | social, 12 weeks | 3.79 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | pain, baseline | 2.09 score on a scale |
| Immediate Start | Quality of Life: PROMIS-29 v2.1 | pain, 12 weeks | 1.57 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | pain, baseline | 2.24 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | physical, baseline | 4.28 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | fatigue, baseline | 3.69 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | physical, 12 weeks | 4.20 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | social, 12 weeks | 3.14 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | anxiety, baseline | 3.55 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | fatigue, 12 weeks | 3.53 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | anxiety, 12 weeks | 3.25 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | pain, 12 weeks | 2.14 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | depression, baseline | 2.48 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | social, baseline | 2.81 score on a scale |
| Waitlist Control | Quality of Life: PROMIS-29 v2.1 | depression, 12 weeks | 2.27 score on a scale |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | Self Efficacy: General Self-Efficacy Scale | GSE, baseline | 28.9 units on a scale |
| Immediate Start | Self Efficacy: General Self-Efficacy Scale | GSE, 12 weeks | 32.3 units on a scale |
| Waitlist Control | Self Efficacy: General Self-Efficacy Scale | GSE, baseline | 28.2 units on a scale |
| Waitlist Control | Self Efficacy: General Self-Efficacy Scale | GSE, 12 weeks | 28.2 units on a scale |
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.
Time frame: 12 weeks
Population: at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | Serum Beta-carotene | baseline | 0.53 umol/L |
| Immediate Start | Serum Beta-carotene | week 12 | 0.66 umol/L |
| Waitlist Control | Serum Beta-carotene | baseline | 0.40 umol/L |
| Waitlist Control | Serum Beta-carotene | week 12 | 0.44 umol/L |
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.
Time frame: 12 weeks
Population: at 12 weeks, data were collected for 21 in the immediate start group and 22 in the waitlist group
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Immediate Start | Serum Vitamin C | baseline | 49.00 umol/L |
| Immediate Start | Serum Vitamin C | week 12 | 50.90 umol/L |
| Waitlist Control | Serum Vitamin C | baseline | 41.36 umol/L |
| Waitlist Control | Serum Vitamin C | week 12 | 42.25 umol/L |