Trial Outcomes & Findings for Cook for Your Life!: Implementing Dietary Change Among Hispanic Breast Cancer Survivors (NCT NCT01414062)
NCT ID: NCT01414062
Last Updated: 2024-08-23
Results Overview
The change in participants intake and fruits and vegetables at 6 months (compared to baseline) as determined by diet recalls collected by an interviewer administered questionnaire.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2024-08-23
Participant Flow
82 participants were enrolled and 12 withdrew, resulting in 70 participants being randomized.
Participant milestones
| Measure |
Arm A (Control)
Participants receiving written dietary recommendations for breast cancer survivors (control arm)
Written dietary recommendations: Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the New York City-based not-for-profit, God's Love We Deliver
|
Arm B (Cocinar Para Su Salud Program)
Participants attending Cocinar Para Su Salud Program held over a 12-week period
Cocinar Para Su Salud Program: A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Arm A (Control)
Participants receiving written dietary recommendations for breast cancer survivors (control arm)
Written dietary recommendations: Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the New York City-based not-for-profit, God's Love We Deliver
|
Arm B (Cocinar Para Su Salud Program)
Participants attending Cocinar Para Su Salud Program held over a 12-week period
Cocinar Para Su Salud Program: A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Left Country
|
1
|
1
|
|
Overall Study
Family Disapproval
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Cook for Your Life!: Implementing Dietary Change Among Hispanic Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Arm A
n=36 Participants
Participants receive written dietary recommendations for breast cancer survivors (control arm)
Written dietary recommendations; Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the NYC-based not-for-profit, God's Love We Deliver
|
Arm B
n=34 Participants
Participants attend the Cocinar Para Su Salud Program held over a 12-week period
Cocinar Para Su Salud Program: A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Colombian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Cuban
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Dominican
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ecuadorian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
El Salvadorian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Honduran
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Puerto Rican
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing Race
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Ethnicity (not specified)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsThe change in participants intake and fruits and vegetables at 6 months (compared to baseline) as determined by diet recalls collected by an interviewer administered questionnaire.
Outcome measures
| Measure |
Arm A (Control Arm)
n=31 Participants
Participants receiving written dietary recommendations for breast cancer survivors (control arm)
Written dietary recommendations: Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the NYC-based not-for-profit, God's Love We Deliver
|
Arm B (Cocinar Para Su Salud Program)
n=30 Participants
Participants attending Cocinar Para Su Salud Program held over a 12-week period
Cocinar Para Su Salud Program: A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
|
|---|---|---|
|
Change in Daily Servings of Fruits and Vegetables
|
-0.1 daily servings of fruits and vegetables
Standard Error 0.5
|
2.0 daily servings of fruits and vegetables
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Data on daily servings of fruits and vegetables were collected from 29 participants from each arm.
The change in participants intake and fruits and vegetables at 12 months (compared to baseline) as determined by diet recalls collected by an interviewer administered questionnaire.
Outcome measures
| Measure |
Arm A (Control Arm)
n=29 Participants
Participants receiving written dietary recommendations for breast cancer survivors (control arm)
Written dietary recommendations: Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the NYC-based not-for-profit, God's Love We Deliver
|
Arm B (Cocinar Para Su Salud Program)
n=29 Participants
Participants attending Cocinar Para Su Salud Program held over a 12-week period
Cocinar Para Su Salud Program: A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
|
|---|---|---|
|
Change in Daily Servings of Fruits and Vegetables
|
-0.2 daily servings of fruits and vegetables
Standard Deviation 2.5
|
1.6 daily servings of fruits and vegetables
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Blood samples for DNA methylation were collected for 24 and 23 participants in Arm A and B respectively resulting in 24 (Arm A) and 23 (Arm B) analyzed.
Fasting blood will be collected at baseline and 12 months to determine whether the change in diet changes participants' biomarkers. Specifically, the change in DNA methylation (a chemical reaction in the body in which a small molecule called a methyl group gets added to DNA) will be measured against the increase in dietary factors.
Outcome measures
| Measure |
Arm A (Control Arm)
n=24 Participants
Participants receiving written dietary recommendations for breast cancer survivors (control arm)
Written dietary recommendations: Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the NYC-based not-for-profit, God's Love We Deliver
|
Arm B (Cocinar Para Su Salud Program)
n=23 Participants
Participants attending Cocinar Para Su Salud Program held over a 12-week period
Cocinar Para Su Salud Program: A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
|
|---|---|---|
|
Change in Molecular Biomarkers Associated With Breast Cancer Risk
|
-0.7 percentage change in DNA methylation
Standard Deviation 3.8
|
1.2 percentage change in DNA methylation
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Data on weight were collected from 29 participants from each arm.
The change in weight from baseline to 12 months.
Outcome measures
| Measure |
Arm A (Control Arm)
n=29 Participants
Participants receiving written dietary recommendations for breast cancer survivors (control arm)
Written dietary recommendations: Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the NYC-based not-for-profit, God's Love We Deliver
|
Arm B (Cocinar Para Su Salud Program)
n=29 Participants
Participants attending Cocinar Para Su Salud Program held over a 12-week period
Cocinar Para Su Salud Program: A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
|
|---|---|---|
|
Change in Weight
|
2.3 kg
Standard Error 2.6
|
-2.2 kg
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Data on BMI were collected from 29 participants from each arm.
The change in BMI from baseline to 12 months.
Outcome measures
| Measure |
Arm A (Control Arm)
n=29 Participants
Participants receiving written dietary recommendations for breast cancer survivors (control arm)
Written dietary recommendations: Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the NYC-based not-for-profit, God's Love We Deliver
|
Arm B (Cocinar Para Su Salud Program)
n=29 Participants
Participants attending Cocinar Para Su Salud Program held over a 12-week period
Cocinar Para Su Salud Program: A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-0.6 kg/m^2
Standard Deviation 2.4
|
-1.0 kg/m^2
Standard Deviation 3.2
|
Adverse Events
Arm A (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B (Cocinar Para Su Salud Program)
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
Dawn Hershman, MD, MS
Columbia University Irving Medical Center
Phone: 212-342-4580
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place