Hypercholesterolemia, Hyperglycemia, Hypertriglyceridemia, Obesity
Conditions
Brief summary
This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; and 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood pressure, glucose and markers of inflammation. This project, if successful, will provide early evidence that targeting dietary behavior around beverage intake could be a novel and easily adopted approach to reduce the burden or delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of the proposed project is the identification of feasible and appropriate beverage intervention strategies to improve engagement and adherence to dietary modification approaches for control of metabolic health indicators in this vulnerable ethnic group.
Detailed description
In the U.S., Hispanics have the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Yet, current literature is limited to information on best practices to engage Hispanics in health-promoting lifestyle interventions. Without this information the health consequences associated with obesity, including high blood pressure, elevated blood glucose and high cholesterol, will continue. Evidence exists to support diet-specific behavioral interventions in reducing obesity-related health risks. Among the more adoptable interventions to date are efforts targeting beverage intake. Yet, there are limited data to suggest these approaches are effective for Hispanics despite this being the fastest growing and highest burdened group for obesity-related disease within the U.S. population. This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood pressure, glucose and markers of inflammation. This project, if successful, will provide early evidence that targeting dietary behavior around beverage intake could be a novel and easily adopted approach to reduce the burden or delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of the proposed project is the identification of feasible and appropriate beverage intervention strategies to improve engagement and adherence to dietary modification approaches for control of metabolic health indicators in this vulnerable ethnic group.
Interventions
OTHERMediterranean 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.
OTHERGreen 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.
OTHERFlavored 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.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Self-identify as Hispanic * 18-64 years of age * BMI between 30 to 50.0 kg/m² * Ability to participate in and provide informed consent. * Speak, read, and write either English and/or Spanish
Exclusion criteria
* Diagnosis of diabetes mellitus * History of liver disease * Current medication for glucose control, cholesterol control; uncontrolled BP * Current eating disorders such as anorexia nervosa, bulimia, etc. (likely to make adherence to prescribed beverage intake difficult) * Current alcohol or substance abuse * Currently treated for psychological issues (i.e. depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years * Report exercise on ≥3 days per week for ≥ 20 minutes per day over the past 3 months * Report weight loss of ≥5% or participating in a weight reduction diet program in the past 3 months * Report plans to relocate to a location that limits their access to the study site or having employment, personal, or travel commitments that prohibit attendance to all of the scheduled assessments * Report consumption of ≥ 1 cup of green tea daily and not willing to complete 2 week run-in period * Report consumption of ≥ 1 cup of citrus fruit daily and not willing to complete 2 week run-in period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction | Week 6 | Participants 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. |
| Study Recruitment: Eligibility | Baseline | The number of Hispanic adults eligible for study inclusion. |
| Study Recruitment: Ineligibility | Baseline | The number of Hispanic adults ineligible for study inclusion. |
| Enrollment | Baseline | The number of Hispanic adults enrolled in the study. |
| Retention | Week 6 | Retention will be measured as the number of participants who remain in the study at 6 weeks. |
| Study Recruitment: Interest in Participation | Baseline | The number of Hispanic adults who contact the researchers and express interest in participation. |
| Study Recruitment: Screened for Eligibility | Baseline | The number of Hispanic adults screened for eligibility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Glucose (Baseline and Week 6) | Baseline and Week 6 | Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose. |
| Change in Hemoglobin A1C (Baseline and Week 6) | Baseline and Week 6 | Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C. |
| Change in Body Weight (Baseline and Week 6) | Baseline and Week 6 | Body weight was measured on a digital scale to assess change in body weight over the intervention period. |
| Change in Total Cholesterol (Baseline and Week 6) | Baseline and Week 6 | Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flavored Water 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. | 10 |
| Mediterranean Lemonade 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. | 21 |
| Green Tea 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. | 19 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Green Tea | Mediterranean Lemonade | Flavored Water |
|---|---|---|---|---|
| Age, Continuous | 44.7 years STANDARD_DEVIATION 10.1 | 48.1 years STANDARD_DEVIATION 10.9 | 44.5 years STANDARD_DEVIATION 9.5 | 39.0 years STANDARD_DEVIATION 7.1 |
| Body Weight | 94.7 kg STANDARD_DEVIATION 19.2 | 89.9 kg STANDARD_DEVIATION 15.1 | 97 kg STANDARD_DEVIATION 17.7 | 99.1 kg STANDARD_DEVIATION 27.9 |
| Fasting Glucose | 92.6 mg/dl STANDARD_DEVIATION 11.7 | 93.7 mg/dl STANDARD_DEVIATION 12.3 | 93.0 mg/dl STANDARD_DEVIATION 12.3 | 89.8 mg/dl STANDARD_DEVIATION 9.8 |
| Hemoglobin A1C | 5.47 % of Hemoglobin A1C STANDARD_DEVIATION 0.34 | 5.46 % of Hemoglobin A1C STANDARD_DEVIATION 0.39 | 5.52 % of Hemoglobin A1C STANDARD_DEVIATION 0.31 | 5.37 % of Hemoglobin A1C STANDARD_DEVIATION 0.28 |
| Race/Ethnicity, Customized Mexican | 30 Participants | 15 Participants | 11 Participants | 4 Participants |
| Race/Ethnicity, Customized Mexican-American | 13 Participants | 3 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Missing | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other Spanish, Hispanic, Latino | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized South/Central American | 3 Participants | 0 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 50 Participants | 19 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Female | 39 Participants | 15 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 4 Participants | 5 Participants | 2 Participants |
| Total Cholesterol | 192.6 mg/dl STANDARD_DEVIATION 38.2 | 200.1 mg/dl STANDARD_DEVIATION 32.8 | 190.5 mg/dl STANDARD_DEVIATION 45.3 | 182.7 mg/dl STANDARD_DEVIATION 31.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 19 | 0 / 10 |
| other Total, other adverse events | 2 / 21 | 0 / 19 | 0 / 10 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 | 0 / 10 |
Outcome results
Primary
Enrollment
The number of Hispanic adults enrolled in the study.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interest in Participation. | Enrollment | 52 Participants |
Primary
Retention
Retention will be measured as the number of participants who remain in the study at 6 weeks.
Time frame: Week 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interest in Participation. | Retention | 44 Participants |
Primary
Study Recruitment: Eligibility
The number of Hispanic adults eligible for study inclusion.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interest in Participation. | Study Recruitment: Eligibility | 104 Participants |
Primary
Study Recruitment: Ineligibility
The number of Hispanic adults ineligible for study inclusion.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interest in Participation. | Study Recruitment: Ineligibility | 132 Participants |
Primary
Study Recruitment: Interest in Participation
The number of Hispanic adults who contact the researchers and express interest in participation.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interest in Participation. | Study Recruitment: Interest in Participation | 279 Participants |
Primary
Study Recruitment: Screened for Eligibility
The number of Hispanic adults screened for eligibility
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interest in Participation. | Study Recruitment: Screened for Eligibility | 236 Participants |
Primary
Treatment Satisfaction
Participants 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.
Time frame: Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interest in Participation. | Treatment Satisfaction | 3.3 units on a scale | Standard Deviation 1.1 |
| Treatment Satisfaction Mediterranean Lemonade | Treatment Satisfaction | 3.4 units on a scale | Standard Deviation 0.9 |
| Treatment Satisfaction Green Tea | Treatment Satisfaction | 3.3 units on a scale | Standard Deviation 1 |
Secondary
Change in Body Weight (Baseline and Week 6)
Body weight was measured on a digital scale to assess change in body weight over the intervention period.
Time frame: Baseline and Week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Interest in Participation. | Change in Body Weight (Baseline and Week 6) | -1.8 kg |
| Treatment Satisfaction Mediterranean Lemonade | Change in Body Weight (Baseline and Week 6) | -0.12 kg |
| Treatment Satisfaction Green Tea | Change in Body Weight (Baseline and Week 6) | -0.36 kg |
Secondary
Change in Fasting Glucose (Baseline and Week 6)
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose.
Time frame: Baseline and Week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Interest in Participation. | Change in Fasting Glucose (Baseline and Week 6) | -1.40 mg/dl |
| Treatment Satisfaction Mediterranean Lemonade | Change in Fasting Glucose (Baseline and Week 6) | 5.2 mg/dl |
| Treatment Satisfaction Green Tea | Change in Fasting Glucose (Baseline and Week 6) | 3.3 mg/dl |
Secondary
Change in Hemoglobin A1C (Baseline and Week 6)
Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C.
Time frame: Baseline and Week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Interest in Participation. | Change in Hemoglobin A1C (Baseline and Week 6) | -0.02 % of Hemoglobin A1C |
| Treatment Satisfaction Mediterranean Lemonade | Change in Hemoglobin A1C (Baseline and Week 6) | 0.05 % of Hemoglobin A1C |
| Treatment Satisfaction Green Tea | Change in Hemoglobin A1C (Baseline and Week 6) | 0.04 % of Hemoglobin A1C |
Secondary
Change in Total Cholesterol (Baseline and Week 6)
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol.
Time frame: Baseline and Week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Interest in Participation. | Change in Total Cholesterol (Baseline and Week 6) | -13.2 mg/dl |
| Treatment Satisfaction Mediterranean Lemonade | Change in Total Cholesterol (Baseline and Week 6) | -1.67 mg/dl |
| Treatment Satisfaction Green Tea | Change in Total Cholesterol (Baseline and Week 6) | -3.9 mg/dl |