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Completed

NCT Number: NCT03975556

Culturally-Adapted Diet for Puerto Rican Adults

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 25-65 y old at the time of enrollment
  • Non-institutionalized
  • 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
  • Able to answer questions without assistance
  • Having a cellphone with the capacity to receive text messages
  • Having at least two of the following:
  • elevated BMI
  • elevated waist circumference
  • self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure
  • self-reported physician-diagnosed pre-diabetes or measured pre-diabetes
  • self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia

Exclusion criteria

  • Under 25 or over 65 years of age
  • 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
  • Institutionalized
  • Not able to answer questions without assistance
  • Not having at least 2 of the five listed metabolic criteria
  • Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin), or diabetes-diagnosis values confirmed by laboratory.
  • Self-reported pregnancy
  • Gastrointestinal or chronic conditions
  • Food intolerance or allergies

Treatment and study plan

Culturally tailored food and diet advice

Behavioral

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

Behavioral

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

Primary outcomes

  1. Number of dysregulated cradiometabolic risk factors

    Time frame: 4 months

    Estimate the change in the number of dysregulated cradiometabolic risk factors (outside of normal values)

  2. Change in levels of adipose risk factor

    Time frame: 4 months

    Estimate the change in the value of waist circumference (cm)

  3. Change in levels of blood pressure risk factors

    Time frame: 4 months

    Estimate the change in the value of systolic and diastolic blood pressure (mmHg)

  4. Change in levels of metabolic risk factors

    Time frame: 4 months

    Estimate the change in the value of glucose, HDL, and triglycerides (mg/dL)

Secondary outcomes

  1. Changes in diet quality score

    Time frame: 4 months

    Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)

  2. Changes in diet satisfaction: diet satisfaction scale

    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)

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • FDI Clinical Research

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2019
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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