Trial Outcomes & Findings for Adherence Dynamics for Whole Food Interventions in African-American Men (NCT NCT01408459)

NCT ID: NCT01408459

Last Updated: 2025-05-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-05-16

Participant Flow

Medical Clinic from June 2007 to Aug 2008

Participant milestones

Measure	Tomato Product Tomato Product: Motivational Telephone Counseling weekly	Control No Motivation telephone Counseling Control: No Motivational telephone Counseling
Overall Study STARTED	22	15
Overall Study COMPLETED	21	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Tomato Product Tomato Product: Motivational Telephone Counseling weekly	Control No Motivation telephone Counseling Control: No Motivational telephone Counseling
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Adherence Dynamics for Whole Food Interventions in African-American Men

Baseline characteristics by cohort

Measure	Tomato Product n=22 Participants Tomato Product: Motivational Telephone Counseling weekly	Control n=15 Participants No Motivation telephone Counseling Control: No Motivational telephone Counseling	Total n=37 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 7.2 • n=5 Participants	68.4 years STANDARD_DEVIATION 7.44 • n=7 Participants	67.1 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Tomato Product n=22 Participants Tomato Product: Motivational Telephone Counseling weekly	Control n=15 Participants No Motivation telephone Counseling Control: No Motivational telephone Counseling
Tomato Product Intake Between Different Groups	6.1 servings/week Standard Deviation 2.1	0.0 servings/week Standard Deviation 0.0

SECONDARY outcome

Timeframe: 3 months

Population: Unit: Number of Participants

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

Outcome measures

Measure	Tomato Product n=22 Participants Tomato Product: Motivational Telephone Counseling weekly	Control n=15 Participants No Motivation telephone Counseling Control: No Motivational telephone Counseling
Diet Adherence to Tomato Product Consumption Between Different Groups	18 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Tomato Product n=22 Participants Tomato Product: Motivational Telephone Counseling weekly	Control n=15 Participants No Motivation telephone Counseling Control: No Motivational telephone Counseling
Consumption of Tomato Products Between Different Groups	22 participants	0 participants

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Tomato Product n=22 Participants Tomato Product: Motivational Telephone Counseling weekly	Control n=15 Participants No Motivation telephone Counseling Control: No Motivational telephone Counseling
Differences in Dietary Lycopene Intake Between Different Groups	20.6 mg/day Standard Deviation 11.3	7.25 mg/day Standard Deviation 9.6

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Tomato Product n=21 Participants Tomato Product: Motivational Telephone Counseling weekly	Control n=12 Participants No Motivation telephone Counseling Control: No Motivational telephone Counseling
Plasma Lycopene Concentration Between Different Groups	0.63 µmol/L Standard Deviation 0.4	0.41 µmol/L Standard Deviation 0.2

Adverse Events

Tomato Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Phyllis E. Bowen

University of Illinois at Chicago

Phone: 708-524-0586

Email: pbowen@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place