FDI Clinical Research
San Juan, 00969, Puerto Rico
NCT Number: NCT03975556
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.
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Notify Me25 year–65 year
All sexes
Interventional
Not applicable
San Juan, 00969, Puerto Rico
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 education includes strategies, foods, portions, and cooking and eating tips included in the My Plate dietary recommendations
Time frame: 4 months
Estimate the change in the number of dysregulated cradiometabolic risk factors (outside of normal values)
Time frame: 4 months
Estimate the change in the value of waist circumference (cm)
Time frame: 4 months
Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
Time frame: 4 months
Estimate the change in the value of glucose, HDL, and triglycerides (mg/dL)
Time frame: 4 months
Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
Time frame: 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)
Harvard School of Public Health (HSPH)
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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