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Completed

NCT Number: NCT03971591

Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors

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 (i.e., decreased adiposity, increased lean mass).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate Guided Lifestyle Program Intervention

Behavioral

The Guided Lifestyle Program will receive sessions that meet twice weekly and 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.

Primary outcomes

  1. Change in body composition

    Time frame: Change from Baseline to 4 month

    Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.

  2. Change in body composition

    Time frame: Change from Baseline to 12 month

    Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.

  3. Increase in intake of fruits and vegetables

    Time frame: Change from Baseline to 4 month

    VioScreen's dietary analysis of self reported food consumption

  4. Increase in intake of fruits and vegetables

    Time frame: Change from Baseline to 12 month

    VioScreen's dietary analysis of self reported food consumption

  5. Decrease of intake of red meat/processed meat

    Time frame: Change from Baseline to 4 month

    VioScreen's dietary analysis of self reported food consumption

  6. Decrease of intake of red meat/processed meat

    Time frame: Change from Baseline to 12 month

    VioScreen's dietary analysis of self reported food consumption

  7. Increase in levels of physical activity- minutes per week

    Time frame: Change from Baseline to 4 month

    Change of ActiGraph monitored activity

  8. Increase in levels of physical activity- minutes per week

    Time frame: Change from Baseline to 12 month

    Change of ActiGraph monitored activity

  9. Increase in levels of physical activity- #times per week

    Time frame: Change from Baseline to 4 month

    Change of ActiGraph monitored activity

  10. Increase in levels of physical activity- #times per week

    Time frame: Change from Baseline to 12 month

    Change of ActiGraph monitored activity

  11. Increase in resistance training- Lower extremity strength

    Time frame: Change from Baseline to 4 month

    Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).

  12. Increase in resistance training- Lower extremity strength

    Time frame: Change from Baseline to 12 month

    Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).

  13. Increase in resistance training- Handgrip strength

    Time frame: Change from Baseline to 4 month

    Takei 5401 Hand Grip Digital Dynamometer

  14. Increase in resistance training- Handgrip strength

    Time frame: Change from Baseline to 12 month

    Takei 5401 Hand Grip Digital Dynamometer

  15. Increase in resistance training- Strength and endurance

    Time frame: Change from Baseline to 4 month

    30-Second Chair Stand (Sit to Stand)

  16. Increase in resistance training- Strength and endurance

    Time frame: Change from Baseline to 12 month

    30-Second Chair Stand (Sit to Stand)

  17. Change in Quality of Life- PROMIS

    Time frame: Change from Baseline to 4 month

    PROMIS T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function.

  18. Change in Quality of Life-PROMIS

    Time frame: Change from Baseline to 4 month

    PROMIS T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function.

  19. Change in Urban life stress inventory- Crisys

    Time frame: Change from Baseline to 4 month

    Measure change of mean in positive/negative/neutral and resolved/ongoing

  20. Change in Urban life stress inventory-Crisys

    Time frame: Change from Baseline to 12 month

    Measure change of mean in positive/negative/neutral and resolved/ongoing

  21. Changes in Blood Pressure

    Time frame: Change from Baseline to 4 month

    Participants blood pressure will be measured using a digital, automated unit

  22. Change in Blood Pressure

    Time frame: Change from Baseline to 12 month

    Participants blood pressure will be measured using a digital, automated unit

  23. Change in Biomarkers- Hemoglobin

    Time frame: Change from Baseline to 4 month

    Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory

  24. Change in Biomarkers-Hemoglobin

    Time frame: Change from Baseline to 12 month

    Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory

  25. Change in Biomarkers- A1C

    Time frame: Change from Baseline to 4 month

    A1C blood tests measured by Wisconsin Diagnostic Laboratory

  26. Change in Biomarkers- A1C

    Time frame: Change from Baseline to 12 month

    A1C blood tests measured by Wisconsin Diagnostic Laboratory

  27. Change in Biomarkers- Hormones-Testosterone

    Time frame: Change from Baseline to 4 month

    Testosterone blood test measured by Wisconsin Diagnostic Laboratory

  28. Change in Biomarkers- Hormones-Testosterone

    Time frame: Change from Baseline to 12 month

    Testosterone blood test measured by Wisconsin Diagnostic Laboratory

  29. Change in Biomarkers- Hormones- Estradiol

    Time frame: Change from Baseline to 4 month

    Estradiol blood test measured by Wisconsin Diagnostic Laboratory

  30. Change in Biomarkers- Hormones- Estradiol

    Time frame: Change from Baseline to 12 month

    Estradiol blood test measured by Wisconsin Diagnostic Laboratory

  31. Change in Biomarkers- Hormones- SHBG

    Time frame: Change from Baseline to 4 month

    SHBG blood test measured by Wisconsin Diagnostic Laboratory

  32. Change in Biomarkers- Hormones- SHBG

    Time frame: Change from Baseline to 12 month

    SHBG blood test measured by Wisconsin Diagnostic Laboratory

  33. Change in Biomarkers-Adipokines- Leptin

    Time frame: Change from Baseline to 4 month

    Leptin blood test measured by Wisconsin Diagnostic Laboratory

  34. Change in Biomarkers-Adipokines- Leptin

    Time frame: Change from Baseline to 12 month

    Leptin,blood test measured by Wisconsin Diagnostic Laboratory

  35. Change in Biomarkers-Adipokines-Adiponectin

    Time frame: Change from Baseline to 4 month

    Adiponectin blood test measured by Wisconsin Diagnostic Laboratory

  36. Change in Biomarkers-Adipokines-Adiponectin

    Time frame: Change from Baseline to 12 month

    Adiponectin blood test measured by Wisconsin Diagnostic Laboratory

  37. Change in Biomarkers-Inflammation- IL-6

    Time frame: Change from Baseline to 4 month

    IL-6 blood test measured by Wisconsin Diagnostic Laboratory

  38. Change in Biomarkers-Inflammation- IL-6

    Time frame: Change from Baseline to 12 month

    IL-6 blood test measured by Wisconsin Diagnostic Laboratory Wisconsin

  39. Change in Biomarkers-Inflammation-TNFα

    Time frame: Change from Baseline to 4 month

    TNFα blood test measured by Wisconsin Diagnostic Laboratory

  40. Change in Biomarkers-Inflammation-TNFα

    Time frame: Change from Baseline to 12 month

    TNFα blood test measured by Wisconsin Diagnostic Laboratory

  41. Change in Biomarkers-Insulin Resistance-C-Peptide

    Time frame: Change from Baseline to 4 month

    C-Peptide blood test measured by Wisconsin Diagnostic Laboratory

  42. Change in Biomarkers-Insulin Resistance- C-Peptide

    Time frame: Change from Baseline to 12 month

    C-Peptide blood test measured by Wisconsin Diagnostic Laboratory

  43. Change in Biomarkers-Insulin Resistance-IGF-1

    Time frame: Change from Baseline to 4 month

    IGF-1 blood test measured by Wisconsin Diagnostic Laboratory

  44. Change in Biomarkers Insulin Resistance-IGF-1

    Time frame: Change from Baseline to 12 month

    IGF-1 blood test measured by Wisconsin Diagnostic Laboratory

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Loyola University Chicago
  • Marquette University
  • University of Illinois at Chicago

Registry information

Acronym: MMF

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2019
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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