Culturally-Adapted Diet for Puerto Rican Adults

NCT03975556 | Completed

• 1 other identifier: IRB19-0184
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 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

• Change in levels of metabolic risk factors

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

  4 months

Secondary Outcomes (2)

• Changes in diet quality score

  4 months

• Changes in diet satisfaction: diet satisfaction scale

  4 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Culturally tailored food and diet advice BEHAVIORAL

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

Intervention

Standard healthy eating advice BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• FDI Clinical Research: collaborator

Study Sites (1)

FDI Clinical Research

San Juan, 00969, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 37181130 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Hypertension; Dyslipidemias; Hypertriglyceridemia; Hyperglycemia; Obesity, Abdominal

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jose F Rodriguez Orengo, PhD

  FDI Clinical Research

  STUDY DIRECTOR

• Josiemer Mattei, PhD, MPH

  Harvard Chan School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nutrition

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 5, 2019
• Study Start: July 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1-year
• Access Criteria: The requested data will be shared with investigators via a secured, password-protected software website, upon request.

Locations

PR (1)