Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors
Ключови думи
Резюме
Описание
Aim 1. To examine the efficacy of the Men Moving Forward guided intervention, as compared to a self-guided control intervention, in producing significant post-intervention changes in body composition in 200 AA PC survivors.
Hypothesis: Men randomized to the guided arm will exhibit significant post-intervention decreases in adiposity and increases in lean body mass compared to men randomized to the control arm.
Aim 2. To investigate the effects of participation in the Men Moving Forward guided intervention on health behaviors and quality of life outcomes.
Hypothesis: Men in the guided program will exhibit increased intake of fruits and vegetables and decreased intake of red meat/processed meat, greater levels of physical activity (minutes per week and #times/wk resistance training) and improved quality of life (targeting physical function, social isolation, sexual functioning) compared to men in the control arm.
Aim 3. To explore the effects of the intervention program on blood pressure, blood lipids, fasting glucose, and biomarkers associated with comorbidities and carcinogenesis (i.e adiponectin, leptin, C-peptide, IGF-1, IGFBP-3, C-Reactive Protein, estradiol, testosterone and sex hormone binding globulin)
Hypothesis: Men in the guided arm will exhibit greater improvements in biomarkers associated with chronic disease and carcionogenesis compared to men in the self-guided control arm.
Men Moving Forward supports PC survivors in adopting physical activity and eating patterns that will improve their body composition, bolster QOL and reduce risk for comorbidities and, potentially, PC recurrence.
Дати
| Последна проверка: | 07/31/2019 |
| Първо изпратено: | 05/08/2019 |
| Очаквано записване подадено: | 05/30/2019 |
| Първо публикувано: | 06/02/2019 |
| Изпратена последна актуализация: | 08/11/2019 |
| Последна актуализация публикувана: | 08/12/2019 |
| Действителна начална дата на проучването: | 05/31/2019 |
| Приблизителна дата на първично завършване: | 06/29/2022 |
| Очаквана дата на завършване на проучването: | 06/29/2023 |
Състояние или заболяване
Интервенция / лечение
Behavioral: Guided Lifestyle Program Intervention
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Guided Lifestyle program The Intervention will be conducted in cohorts of 15-20. We anticipate there will be 5-6 cohorts over the course of the study. Men assigned to the Guided Lifestyle Program will participate in twice weekly sessions - the first weekly session will be 120 minutes in length with the first hour addressing lifestyle change education and strategies, the second hour will be supervised exercise with strength training. The second weekly session will be a one-hour supervised exercise session with strength training. Men will also receive 2-3 text messages weekly. They will also receive a participant informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines. | |
| Active Comparator: Self-Guided Lifestyle program In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging. The study team will call these participants once a month to check in. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Male |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Age 18 years and older - Self-identify as Black or African American - Diagnosed with non-metastatic Prostate Cancer (cancer that has NOT spread elsewhere in the body) - Completed all treatments (including Androgen Deprivation Therapy) at least six months prior to enrollment - BMI > 25 kg/m2 - Able to participate in moderate physical activity as assessed by healthcare provider - Exercise less than the ACS recommended guideline of 150 min/week or 30 min/day. - Fruit and vegetable consumption is less than 5 servings each day. - Lift Weights or engage in strength training less than twice a week. - Can walk continuously for 5 minutes without stopping because of pain or shortness of breath. - Have access to a mobile phone - Approval from Primary Care Provider/Medical Oncologist - Available to attend intervention Exclusion Criteria: - • Does not meet the Inclusion Criteria |
Резултат
Първични изходни мерки
1. Change in body composition [Change from Baseline to 4 month]
2. Change in body composition [Change from Baseline to 12 month]
3. Increase in intake of fruits and vegetables [Change from Baseline to 4 month]
4. Increase in intake of fruits and vegetables [Change from Baseline to 12 month]
5. Decrease of intake of red meat/processed meat [Change from Baseline to 4 month]
6. Decrease of intake of red meat/processed meat [Change from Baseline to 12 month]
7. Increase in levels of physical activity- minutes per week [Change from Baseline to 4 month]
8. Increase in levels of physical activity- minutes per week [Change from Baseline to 12 month]
9. Increase in levels of physical activity- #times per week [Change from Baseline to 4 month]
10. Increase in levels of physical activity- #times per week [Change from Baseline to 12 month]
11. Increase in resistance training- Lower extremity strength [Change from Baseline to 4 month]
12. Increase in resistance training- Lower extremity strength [Change from Baseline to 12 month]
13. Increase in resistance training- Handgrip strength [Change from Baseline to 4 month]
14. Increase in resistance training- Handgrip strength [Change from Baseline to 12 month]
15. Increase in resistance training- Strength and endurance [Change from Baseline to 4 month]
16. Increase in resistance training- Strength and endurance [Change from Baseline to 12 month]
17. Change in Quality of Life- PROMIS [Change from Baseline to 4 month]
18. Change in Quality of Life-PROMIS [Change from Baseline to 4 month]
19. Change in Urban life stress inventory- Crisys [Change from Baseline to 4 month]
20. Change in Urban life stress inventory-Crisys [Change from Baseline to 12 month]
21. Changes in Blood Pressure [Change from Baseline to 4 month]
22. Change in Blood Pressure [Change from Baseline to 12 month]
23. Change in Biomarkers- Hemoglobin [Change from Baseline to 4 month]
24. Change in Biomarkers-Hemoglobin [Change from Baseline to 12 month]
25. Change in Biomarkers- A1C [Change from Baseline to 4 month]
26. Change in Biomarkers- A1C [Change from Baseline to 12 month]
27. Change in Biomarkers- Hormones-Testosterone [Change from Baseline to 4 month]
28. Change in Biomarkers- Hormones-Testosterone [Change from Baseline to 12 month]
29. Change in Biomarkers- Hormones- Estradiol [Change from Baseline to 4 month]
30. Change in Biomarkers- Hormones- Estradiol [Change from Baseline to 12 month]
31. Change in Biomarkers- Hormones- SHBG [Change from Baseline to 4 month]
32. Change in Biomarkers- Hormones- SHBG [Change from Baseline to 12 month]
33. Change in Biomarkers-Adipokines- Leptin [Change from Baseline to 4 month]
34. Change in Biomarkers-Adipokines- Leptin [Change from Baseline to 12 month]
35. Change in Biomarkers-Adipokines-Adiponectin [Change from Baseline to 4 month]
36. Change in Biomarkers-Adipokines-Adiponectin [Change from Baseline to 12 month]
37. Change in Biomarkers-Inflammation- IL-6 [Change from Baseline to 4 month]
38. Change in Biomarkers-Inflammation- IL-6 [Change from Baseline to 12 month]
39. Change in Biomarkers-Inflammation-TNFα [Change from Baseline to 4 month]
40. Change in Biomarkers-Inflammation-TNFα [Change from Baseline to 12 month]
41. Change in Biomarkers-Insulin Resistance-C-Peptide [Change from Baseline to 4 month]
42. Change in Biomarkers-Insulin Resistance- C-Peptide [Change from Baseline to 12 month]
43. Change in Biomarkers-Insulin Resistance-IGF-1 [Change from Baseline to 4 month]
44. Change in Biomarkers Insulin Resistance-IGF-1 [Change from Baseline to 12 month]
