Culturally-Adapted Diet for Puerto Rican Adults

Obesity Clinical Trial

Official title:

Culturally-Adapted Diet for Puerto Rican Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03975556
• Other study ID #: IRB19-0184
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Puerto Rico	FDI Clinical Research	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	FDI Clinical Research

Country where clinical trial is conducted

Puerto Rico, 

Outcome

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