Adherence Dynamics for Whole Food Interventions in African-American Men (DAPH)

The purposes of this study are to explore the dynamics of adherence, using a simple whole food intervention strategy, both prior to and during the intervention period and to identify nutrient shifts in self-selected diets and to determine health risks (blood pressure, hyperlipidemia, and body weight) that may have resulted from increased tomato product consumption.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Tomato Product; Dietary supplement: Control

Detailed Description

African-American (AA) men suffer the greatest proportion of health disparities of any studied category and adherence to advice among this group has been vastly understudied.

Although there are several ongoing trials for behavioral change, either of diet or lifestyle, enrollment rates of AA men (< 25%) often provide insufficient numbers to evaluate adherence issues separately.

Tomatoes, more than lycopene alone, may have beneficial effects on prostate health, including BPH and prostate cancer. Efficacy trials would require long-term adherence to high levels of tomato product (TP) consumption.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60606
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• African-American men aged ≥ 50 yr who recently were found to have serum prostate specific antigen (PSA) concentrations of >2.5 ng/mL with negative prostate biopsy for prostate cancer.
• English literacy
• willing to consume tomato products on a regular basis.

Exclusion Criteria:

• prostate cancer diagnosis
• other cancers < 5 yrs postdiagnosis except for melanoma
• already consuming four 1/2 cup servings of tomato products/wk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tomato product; Motivational telephone counseling weekly	Dietary supplement: Tomato Product; Motivational Telephone Counseling weekly; Other Names: Intervention group
Placebo Comparator: Control; No Motivation telephone Counseling	Dietary supplement: Control; No Motivational telephone Counseling; Other Names: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tomato Product Intake Between Different Groups	The intervention group: aimed to achieve the goal of more than five servings of TP/week while control group aimed to eat vegetable instead of tomatoes.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet Adherence to Tomato Product Consumption Between Different Groups	Using 24-hr recall weekly, consumption of tomato product was measured by serving size.	3 months
Consumption of Tomato Products Between Different Groups	Using 24-hr diet recall, types of tomato products were counted.	3 months
Differences in Dietary Lycopene Intake Between Different Groups		3 months
Plasma Lycopene Concentration Between Different Groups		3 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Eunyoung Park, M.S., University of Illinois at Chicago

Publications and helpful links

General Publications

• Park E, Stacewicz-Sapuntzakis M, Sharifi R, Wu Z, Freeman VL, Bowen PE. Diet adherence dynamics and physiological responses to a tomato product whole-food intervention in African-American men. Br J Nutr. 2013 Jun 28;109(12):2219-30. doi: 10.1017/S0007114512004436. Epub 2012 Nov 19.

Helpful Links

• Pubmed

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2007
• Primary Completion (Actual): August 30, 2008
• Study Completion (Actual): September 30, 2008

Study Registration Dates

• First Submitted: August 1, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 8, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Prostate cancer prevention
• Other Study ID Numbers: 2006-0354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No