Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Abdominal Obesity
  • Diabetes Mellitus - Type 2
  • Dyslipidemias
  • High Blood Glucose
  • High Triglycerides
  • Hypertension
  • Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes 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.Primary Purpose: Prevention

Participation Requirements

Age
Between 25 years and 65 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT03975556
Collaborators
FDI Clinical Research
Investigators
Study Director: Jose F Rodriguez Orengo, PhD FDI Clinical Research Principal Investigator: Josiemer Mattei, PhD, MPH Harvard Chan School of Public Health