Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03971591
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2019-05-09
Brief Title:
Men Moving Forward A Lifestyle Program for African-American Prostate Cancer Survivors
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Men Moving Forward A Lifestyle Program for African-American Prostate Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MMF
Brief Summary:
This study will examine the efficacy of Men Moving Forward MMF a four-month community-based lifestyle intervention designed for AA PC survivors MMF is rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors This intervention was adapted in collaboration with AA PC survivors It will offer twice weekly sessions aimed at supporting adherence to the ACS nutrition and physical activity guidelines to promote improved body composition ie decreased adiposity increased lean mass
Detailed Description:
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 meatprocessed meat greater levels of physical activity minutes per week and timeswk 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 ie 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
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 meatprocessed meat greater levels of physical activity minutes per week and timeswk 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None