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

• Sponsor: University of Illinois at Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT01408459
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Tomato Product; Dietary Supplement: Control	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Adherence Dynamics for Whole Food Interventions in African-American Men
• Actual Study Start Date: Jan 4, 2007
• Actual Primary Completion Date: Aug 30, 2008
• Actual Study Completion Date: Sep 30, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tomato Product Intake Between Different Groups [3 months]

   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.

Secondary Outcome Measures

1. Diet Adherence to Tomato Product Consumption Between Different Groups [3 months]

   Using 24-hr recall weekly, consumption of tomato product was measured by serving size.

2. Consumption of Tomato Products Between Different Groups [3 months]

   Using 24-hr diet recall, types of tomato products were counted.

3. Differences in Dietary Lycopene Intake Between Different Groups [3 months]

4. Plasma Lycopene Concentration Between Different Groups [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60606

Sponsors and Collaborators

• University of Illinois at Chicago

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Pubmed

Publications

None provided.

• Responsible Party: Eunyoung Park, Student, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT01408459
• Other Study ID Numbers: 2006-0354
• First Posted: Aug 3, 2011
• Last Update Posted: Sep 2, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eunyoung Park, Student, University of Illinois at Chicago: Prostate cancer prevention

Study Results

Participant Flow

Recruitment Details	Medical Clinic from June 2007 to Aug 2008

Arm/Group Title	Tomato Product	Control
Arm/Group Description	Tomato Product: Motivational Telephone Counseling weekly	No Motivation telephone Counseling Control: No Motivational telephone Counseling
Period Title: Overall Study
STARTED	22	15
COMPLETED	21	14
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Tomato Product	Control	Total
Arm/Group Description	Tomato Product: Motivational Telephone Counseling weekly	No Motivation telephone Counseling Control: No Motivational telephone Counseling	Total of all reporting groups
Overall Participants	22	15	37
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.2 (7.2)	68.4 (7.44)	67.1 (7.3)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	22 100%	15 100%	37 100%

Outcome Measures

1. Primary Outcome

Title	Tomato Product Intake Between Different Groups
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tomato Product	Control
Arm/Group Description	Tomato Product: Motivational Telephone Counseling weekly	No Motivation telephone Counseling Control: No Motivational telephone Counseling
Measure Participants	22	15
Mean (Standard Deviation) [servings/week]	6.1 (2.1)	0.0 (0.0)

2. Secondary Outcome

Title	Diet Adherence to Tomato Product Consumption Between Different Groups
Description	Using 24-hr recall weekly, consumption of tomato product was measured by serving size.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Unit: Number of Participants

Arm/Group Title	Tomato Product	Control
Arm/Group Description	Tomato Product: Motivational Telephone Counseling weekly	No Motivation telephone Counseling Control: No Motivational telephone Counseling
Measure Participants	22	15
Count of Participants [Participants]	18 81.8%	5 33.3%

3. Secondary Outcome

Title	Consumption of Tomato Products Between Different Groups
Description	Using 24-hr diet recall, types of tomato products were counted.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tomato Product	Control
Arm/Group Description	Tomato Product: Motivational Telephone Counseling weekly	No Motivation telephone Counseling Control: No Motivational telephone Counseling
Measure Participants	22	15
Number [participants]	22 100%	0 0%

4. Secondary Outcome

Title	Differences in Dietary Lycopene Intake Between Different Groups
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tomato Product	Control
Arm/Group Description	Motivational telephone counseling weekly Tomato Product: Motivational Telephone Counseling weekly	No Motivation telephone Counseling Control: No Motivational telephone Counseling
Measure Participants	22	15
Mean (Standard Deviation) [mg/day]	20.6 (11.3)	7.25 (9.6)

5. Secondary Outcome

Title	Plasma Lycopene Concentration Between Different Groups
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tomato Product	Control
Arm/Group Description	Tomato Product: Motivational Telephone Counseling weekly	No Motivation telephone Counseling Control: No Motivational telephone Counseling
Measure Participants	21	12
Mean (Standard Deviation) [µmol/L]	0.63 (0.4)	0.41 (0.2)

Adverse Events

Time Frame	3 months
Arm/Group Title	Tomato Product		Control
Arm/Group Description	Tomato Product: Motivational Telephone Counseling weekly		No Motivation telephone Counseling Control: No Motivational telephone Counseling
All Cause Mortality
	Tomato Product		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tomato Product		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Tomato Product		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/15 (0%)

Limitations/Caveats

The number of phone calls and collected diet recalls between groups was different because of concern that the control group would increase their tomato product intake.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.