Clinical trial NCT03975556: Culturally-Adapted Diet for Puerto Rican Adults
Official title: Culturally-Adapted Diet for Puerto Rican Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Hypertension
Dyslipidemias
High Triglycerides
High Blood Glucose
Abdominal Obesity
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: FDI Clinical Research
First posted: 2019-06-05
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of dysregulated cradiometabolic risk factors
timeFrame: 4 months
measure: Change in levels of adipose risk factor
timeFrame: 4 months
measure: Change in levels of blood pressure risk factors
timeFrame: 4 months
measure: Change in levels of metabolic risk factors
timeFrame: 4 months
Secondary outcomes:
measure: Changes in diet quality score
timeFrame: 4 months
measure: Changes in diet satisfaction: diet satisfaction scale
timeFrame: 4 months
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
Study officials:
affiliation: FDI Clinical Research
name: Jose F Rodriguez Orengo, PhD
role: STUDY_DIRECTOR
affiliation: Harvard Chan School of Public Health
name: Josiemer Mattei, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: