Trial Outcomes & Findings for Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults (NCT NCT02911753)
NCT ID: NCT02911753
Last Updated: 2019-10-25
Results Overview
The number of Hispanic adults screened for eligibility
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline
Results posted on
2019-10-25
Participant Flow
Participant milestones
| Measure |
Mediterranean Lemonade Consumption
All participants will be asked to consume 32 ounces daily of Mediterranean Lemonade. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.
Mediterranean Lemonade: All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
|
Green Tea Consumption
All participants will be asked to consume 32 ounces daily of Green Tea. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.
Green Tea: All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
|
Flavored Water Consumption
All participants will be asked to consume 32 ounces daily of Flavored Water. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.
Flavored Water: All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
10
|
|
Overall Study
COMPLETED
|
18
|
16
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults
Baseline characteristics by cohort
| Measure |
Flavored Water
n=10 Participants
All participants were advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages were prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants were provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants were asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages were provided.
|
Mediterranean Lemonade
n=21 Participants
All participants were advised to consume all of the beverage assigned (Mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages were prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants were provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants were asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages were provided.
|
Green Tea
n=19 Participants
All participants were advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages were prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants were provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants were asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages were provided.
|
Total
n=50 Participants
Total of all reporting groups
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|---|---|---|---|---|
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Age, Continuous
|
39.0 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mexican-American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
South/Central American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other Spanish, Hispanic, Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Total Cholesterol
|
182.7 mg/dl
STANDARD_DEVIATION 31.6 • n=5 Participants
|
190.5 mg/dl
STANDARD_DEVIATION 45.3 • n=7 Participants
|
200.1 mg/dl
STANDARD_DEVIATION 32.8 • n=5 Participants
|
192.6 mg/dl
STANDARD_DEVIATION 38.2 • n=4 Participants
|
|
Fasting Glucose
|
89.8 mg/dl
STANDARD_DEVIATION 9.8 • n=5 Participants
|
93.0 mg/dl
STANDARD_DEVIATION 12.3 • n=7 Participants
|
93.7 mg/dl
STANDARD_DEVIATION 12.3 • n=5 Participants
|
92.6 mg/dl
STANDARD_DEVIATION 11.7 • n=4 Participants
|
|
Hemoglobin A1C
|
5.37 % of Hemoglobin A1C
STANDARD_DEVIATION 0.28 • n=5 Participants
|
5.52 % of Hemoglobin A1C
STANDARD_DEVIATION 0.31 • n=7 Participants
|
5.46 % of Hemoglobin A1C
STANDARD_DEVIATION 0.39 • n=5 Participants
|
5.47 % of Hemoglobin A1C
STANDARD_DEVIATION 0.34 • n=4 Participants
|
|
Body Weight
|
99.1 kg
STANDARD_DEVIATION 27.9 • n=5 Participants
|
97 kg
STANDARD_DEVIATION 17.7 • n=7 Participants
|
89.9 kg
STANDARD_DEVIATION 15.1 • n=5 Participants
|
94.7 kg
STANDARD_DEVIATION 19.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: BaselineThe number of Hispanic adults who contact the researchers and express interest in participation.
Outcome measures
| Measure |
Interest in Participation.
n=279 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
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|---|---|---|---|
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Study Recruitment: Interest in Participation
|
279 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineThe number of Hispanic adults screened for eligibility
Outcome measures
| Measure |
Interest in Participation.
n=279 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
|---|---|---|---|
|
Study Recruitment: Screened for Eligibility
|
236 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineThe number of Hispanic adults eligible for study inclusion.
Outcome measures
| Measure |
Interest in Participation.
n=236 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
|---|---|---|---|
|
Study Recruitment: Eligibility
|
104 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineThe number of Hispanic adults ineligible for study inclusion.
Outcome measures
| Measure |
Interest in Participation.
n=236 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
|---|---|---|---|
|
Study Recruitment: Ineligibility
|
132 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineThe number of Hispanic adults enrolled in the study.
Outcome measures
| Measure |
Interest in Participation.
n=104 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
|---|---|---|---|
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Enrollment
|
52 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 6Retention will be measured as the number of participants who remain in the study at 6 weeks.
Outcome measures
| Measure |
Interest in Participation.
n=50 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
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|---|---|---|---|
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Retention
|
44 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 6Participants will be asked to rate their overall satisfaction (1- low; 4-high) with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
Outcome measures
| Measure |
Interest in Participation.
n=10 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
n=21 Participants
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
n=19 Participants
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
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|---|---|---|---|
|
Treatment Satisfaction
|
3.3 units on a scale
Standard Deviation 1.1
|
3.4 units on a scale
Standard Deviation 0.9
|
3.3 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and Week 6Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol.
Outcome measures
| Measure |
Interest in Participation.
n=10 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
n=21 Participants
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
n=19 Participants
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
|---|---|---|---|
|
Change in Total Cholesterol (Baseline and Week 6)
|
-13.2 mg/dl
Interval -30.2 to 3.8
|
-1.67 mg/dl
Interval -14.2 to 10.9
|
-3.9 mg/dl
Interval -17.2 to 9.4
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SECONDARY outcome
Timeframe: Baseline and Week 6Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose.
Outcome measures
| Measure |
Interest in Participation.
n=10 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
n=21 Participants
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
n=19 Participants
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
|---|---|---|---|
|
Change in Fasting Glucose (Baseline and Week 6)
|
-1.40 mg/dl
Interval -5.0 to 2.2
|
5.2 mg/dl
Interval 2.6 to 7.9
|
3.3 mg/dl
Interval 0.58 to 6.4
|
SECONDARY outcome
Timeframe: Baseline and Week 6Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C.
Outcome measures
| Measure |
Interest in Participation.
n=10 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
n=21 Participants
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
n=19 Participants
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
|---|---|---|---|
|
Change in Hemoglobin A1C (Baseline and Week 6)
|
-0.02 % of Hemoglobin A1C
Interval -0.14 to 0.1
|
0.05 % of Hemoglobin A1C
Interval -0.04 to 0.14
|
0.04 % of Hemoglobin A1C
Interval -0.06 to 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 6Body weight was measured on a digital scale to assess change in body weight over the intervention period.
Outcome measures
| Measure |
Interest in Participation.
n=10 Participants
The number of Hispanic adults who contact the researchers and express interest in participation.
|
Treatment Satisfaction Mediterranean Lemonade
n=21 Participants
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
Treatment Satisfaction Green Tea
n=19 Participants
Participants will be asked to rate their overall satisfaction with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
|
|---|---|---|---|
|
Change in Body Weight (Baseline and Week 6)
|
-1.8 kg
Interval -2.9 to -0.55
|
-0.12 kg
Interval -1.0 to 0.8
|
-0.36 kg
Interval -1.6 to 1.8
|
Adverse Events
Mediterranean Lemonade Consumption
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Green Tea Consumption
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flavored Water Consumption
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mediterranean Lemonade Consumption
n=21 participants at risk
All participants will be asked to consume 32 ounces daily of Mediterranean Lemonade. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.
Mediterranean Lemonade: All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
|
Green Tea Consumption
n=19 participants at risk
All participants will be asked to consume 32 ounces daily of Green Tea. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.
Green Tea: All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
|
Flavored Water Consumption
n=10 participants at risk
All participants will be asked to consume 32 ounces daily of Flavored Water. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks.
Flavored Water: All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
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|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Distress
|
9.5%
2/21 • Number of events 2 • 1 year (August 2016-August 2017)
|
0.00%
0/19 • 1 year (August 2016-August 2017)
|
0.00%
0/10 • 1 year (August 2016-August 2017)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place