Culturally-Adapted Diet for Puerto Rican Adults

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Diabetes Mellitus, Type 2; Dyslipidemias; Abdominal Obesity; High Triglycerides; High Blood Glucose
• Intervention / Treatment: Behavioral: Culturally tailored food and diet advice; Behavioral: Standard healthy eating advice

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00969
    • FDI Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in levels of adipose risk factor	Estimate the change in the value of waist circumference (cm)	4 months
Change in levels of blood pressure risk factors	Estimate the change in the value of systolic and diastolic blood pressure (mmHg)	4 months
Number of dysregulated cradiometabolic risk factors	Estimate the change in the number of dysregulated cradiometabolic risk factors (outside of normal values)	4 months
Change in levels of metabolic risk factors	Estimate the change in the value of glucose, HDL, and triglycerides (mg/dL)	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in diet quality score	Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)	4 months
Changes in diet satisfaction: diet satisfaction scale	Determine the change in the score of the Diet Satisfaction Questionnaire (DSat-45) (range 45-225; from lowest to highest satisfaction) and its summed seven subscales (ranges 5-40)	4 months

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: FDI Clinical Research
• Investigators: Study Director: Jose F Rodriguez Orengo, PhD, FDI Clinical Research; Principal Investigator: Josiemer Mattei, PhD, MPH, Harvard Chan School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Lipid Metabolism Disorders; Hyperlipidemias; Hyperglycemia; Diabetes Mellitus, Type 2; Obesity; Dyslipidemias; Hypertriglyceridemia; Obesity, Abdominal
• Other Study ID Numbers: IRB19-0184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be managed and distributed observing NIH and IRB policies on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being de-identified and properly revised for quality control by contacting study investigators.
• IPD Sharing Time Frame: 1-year
• IPD Sharing Access Criteria: The requested data will be shared with investigators via a secured, password-protected software website, upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No