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Culturally-Adapted Diet for Puerto Rican Adults

Primary Purpose

Diabetes Mellitus, Type 2, Obesity, Hypertension

Status

Completed

Phase

Not Applicable

Locations

Puerto Rico

Study Type

Interventional

Intervention

Culturally tailored food and diet advice

Standard healthy eating advice

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 25-65 y old at the time of enrollment
Non-institutionalized
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
Able to answer questions without assistance
Having a cellphone with the capacity to receive text messages
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:

Under 25 or over 65 years of age
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
Institutionalized
Not able to answer questions without assistance
Not having at least 2 of the five listed metabolic criteria
Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin), or diabetes-diagnosis values confirmed by laboratory.
Self-reported pregnancy
Gastrointestinal or chronic conditions
Food intolerance or allergies

Sites / Locations

FDI Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of dysregulated cradiometabolic risk factors

Estimate the change in the number of dysregulated cradiometabolic risk factors (outside of normal values)

Change in levels of adipose risk factor

Estimate the change in the value of waist circumference (cm)

Change in levels of blood pressure risk factors

Estimate the change in the value of systolic and diastolic blood pressure (mmHg)

Change in levels of metabolic risk factors

Estimate the change in the value of glucose, HDL, and triglycerides (mg/dL)

Secondary Outcome Measures

Changes in diet quality score

Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)

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)

Full Information

NCT ID

NCT03975556

First Posted

May 30, 2019

Last Updated

July 21, 2021

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

FDI Clinical Research

1. Study Identification

Unique Protocol Identification Number

NCT03975556

Brief Title

Culturally-Adapted Diet for Puerto Rican Adults

Official Title

Culturally-Adapted Diet for Puerto Rican Adults

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harvard School of Public Health (HSPH)

Collaborators

FDI Clinical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Participants will be unaware of the which educational messages are considered intervention or control. Investigators will not be in contact with participants and will only receive coded data. Outcome assessor will be unaware of treatment allocation of participant.

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Culturally tailored food and diet advice

Intervention Description

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

Intervention Name(s)

Standard healthy eating advice

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of dysregulated cradiometabolic risk factors

Description

Estimate the change in the number of dysregulated cradiometabolic risk factors (outside of normal values)

Time Frame

4 months

Title

Change in levels of adipose risk factor

Description

Estimate the change in the value of waist circumference (cm)

Time Frame

4 months

Title

Change in levels of blood pressure risk factors

Description

Estimate the change in the value of systolic and diastolic blood pressure (mmHg)

Time Frame

4 months

Title

Change in levels of metabolic risk factors

Description

Estimate the change in the value of glucose, HDL, and triglycerides (mg/dL)

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Changes in diet quality score

Description

Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)

Time Frame

4 months

Title

Changes in diet satisfaction: diet satisfaction scale

Description

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)

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 25-65 y old at the time of enrollment Non-institutionalized 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 Able to answer questions without assistance Having a cellphone with the capacity to receive text messages Having at least two of the following: elevated BMI elevated waist circumference self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure self-reported physician-diagnosed pre-diabetes or measured pre-diabetes self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia Exclusion Criteria: Under 25 or over 65 years of age 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 Institutionalized Not able to answer questions without assistance Not having at least 2 of the five listed metabolic criteria Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin), or diabetes-diagnosis values confirmed by laboratory. Self-reported pregnancy Gastrointestinal or chronic conditions Food intolerance or allergies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose F Rodriguez Orengo, PhD

Organizational Affiliation

FDI Clinical Research

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Josiemer Mattei, PhD, MPH

Organizational Affiliation

Harvard Chan School of Public Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

FDI Clinical Research

City

San Juan

ZIP/Postal Code

00969

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Culturally-Adapted Diet for Puerto Rican Adults

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