Culturally-Adapted Diet for Puerto Rican Adults

Not Applicable

Completed

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

• Registration Number: NCT03975556
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-05
• Study Start: 2019-07-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Culturally tailored food and diet advice	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	Standard healthy eating advice	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in diet quality score	4 months	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	4 months	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)

Trial Locations

Locations (1)

FDI Clinical Research; 🇵🇷 San Juan, Puerto Rico