Trials / Completed
CompletedNCT03975556
Culturally-Adapted Diet for Puerto Rican Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Harvard School of Public Health (HSPH) · Academic / Other
- Sex
- All
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Diabetes Mellitus, Type 2
- Obesity
- Hypertension
- Dyslipidemias
- High Triglycerides
- High Blood Glucose
- Abdominal Obesity
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | Standard healthy eating advice | Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate dietary recommendations |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
- First posted
- 2019-06-05
- Last updated
- 2021-07-23
Locations
1 site across 1 country: Puerto Rico
Source: ClinicalTrials.gov record NCT03975556. Inclusion in this directory is not an endorsement.