Culturally-Adapted Diet for Puerto Rican Adults

NCT ID: NCT03975556

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-06-30

Brief Summary

This pilot project will determine whether a diet culturally-adapted to Puerto Ricans can effectively decrease cardiometabolic risk for diabetes. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2 diabetes and obesity outcomes.

Detailed Description

This pilot intervention will culturally-tailor a diet to the Puerto Rican adult population based on staple foods as well as culturally-appropriate strategies to reduce cardiometabolic risk factors of type 2 diabetes and obesity. Based on preliminary results from studies in the island, investigators will conduct a 4-month, 2-arm intervention among 200 adults (100 per arm) ages 25-65 living in Puerto Rico with at least 2 of 5 cardiometabolic risk factors. The two arms are: (1) intervention group consisting of culturally-appropriate advice in an initial individual session with daily text messages for 2 months (delivery phase); (2) control arm of standard general nutritional advice at the initial individual session, and text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the education and text messages. Investigators will measure changes in cardiometabolic risk factors and in eating-behaviors and psychological measures.

Conditions

Diabetes Mellitus, Type 2; Obesity; Hypertension; Dyslipidemias; High Triglycerides; High Blood Glucose; Abdominal Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Intervention

Intervention group consisting of culturally-appropriate foods and diet advice in an initial individual session followed by daily text messages for 2 months (delivery phase). A reinforcement phase of 2-months will follow to repeat the text messages.

Group Type: EXPERIMENTAL

Culturally tailored food and diet advice

Intervention Type: BEHAVIORAL

Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.

Control

Control arm of standard portion-control general nutritional and cooking advice at the initial individual session, followed by text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the education and text messages.

Group Type: ACTIVE_COMPARATOR

Standard healthy eating advice

Intervention Type: BEHAVIORAL

Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate dietary recommendations

Interventions

Culturally tailored food and diet advice

Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.

Intervention Type: BEHAVIORAL

Standard healthy eating advice

Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate dietary recommendations

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age 25-65 y old at the time of enrollment

2. Non-institutionalized

3. Living in PR at the time of recruitment and for at least the previous year and not planning to move from the island within the next 6 months

4. Able to answer questions without assistance

5. Having a cellphone with the capacity to receive text messages

6. Having at least two of the following:

1. elevated BMI

2. elevated waist circumference

3. self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure

4. self-reported physician-diagnosed pre-diabetes or measured pre-diabetes

5. self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia

Exclusion Criteria

1. Under 25 or over 65 years of age

2. Currently do not live in Puerto Rico or have not lived in PR for at least 1 year or plan to move within 6 months

3. Institutionalized

4. Not able to answer questions without assistance

5. Not having at least 2 of the five listed metabolic criteria

6. Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin), or diabetes-diagnosis values confirmed by laboratory.

7. Self-reported pregnancy

8. Gastrointestinal or chronic conditions

9. Food intolerance or allergies

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FDI Clinical Research

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: lead

Responsible Party

Josiemer Mattei

Assistant Professor of Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose F Rodriguez Orengo, PhD

Role: STUDY_DIRECTOR

FDI Clinical Research

Josiemer Mattei, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard Chan School of Public Health

Locations

FDI Clinical Research

San Juan, , Puerto Rico

Countries

Puerto Rico

References

Mattei J, Diaz-Alvarez CB, Alfonso C, O'Neill HJ, Rios-Bedoya CF, Malik VS, Godoy-Vitorino F, Cheng C, Spiegelman D, Willett WC, Hu FB, Rodriguez-Orengo JF. Design and Implementation of a Culturally-Tailored Randomized Pilot Trial: Puerto Rican Optimized Mediterranean-Like Diet. Curr Dev Nutr. 2022 Dec 23;7(1):100022. doi: 10.1016/j.cdnut.2022.100022. eCollection 2023 Jan.

Reference Type: DERIVED

PMID: 37181130 (View on PubMed)

Other Identifiers

IRB19-0184

Identifier Type: -

Identifier Source: org_study_id