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Culturally-Adapted Diet for Puerto Rican Adults

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ClinicalTrials.gov Identifier: NCT03975556
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
FDI Clinical Research
Information provided by (Responsible Party):
Josiemer Mattei, Harvard School of Public Health

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Obesity Hypertension Dyslipidemias High Triglycerides High Blood Glucose Abdominal Obesity Behavioral: Culturally tailored food and diet advice Behavioral: Standard healthy eating advice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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
Official Title: Culturally-Adapted Diet for Puerto Rican Adults
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Arm Intervention/treatment
Experimental: Intervention
Intervention group consisting of culturally-appropriate foods and diet advice in an initial individual session followed by daily text messages for 2 months (delivery phase). A reinforcement phase of 2-months will follow to repeat the text messages.
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.

Active Comparator: Control
Control arm of standard portion-control general nutritional and cooking advice at the initial individual session, followed by text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the education and text messages.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975556


Contacts
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Contact: Claudia Diaz, MPH 787-722-1248 ext 245 cbdiaz@fdipr.com
Contact: Michelle Echeandia, MS 787-722-1248 mecheandia@fdipr.com

Locations
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Puerto Rico
FDI Clinical Research Recruiting
San Juan, Puerto Rico, 00969
Contact: Claudia Diaz, MPH    787-722-1248 ext 245    cbdiaz@fdipr.com   
Sponsors and Collaborators
Harvard School of Public Health
FDI Clinical Research
Investigators
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Study Director: Jose F Rodriguez Orengo, PhD FDI Clinical Research
Principal Investigator: Josiemer Mattei, PhD, MPH Harvard Chan School of Public Health

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Responsible Party: Josiemer Mattei, Assistant Professor of Nutrition, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03975556     History of Changes
Other Study ID Numbers: IRB19-0184
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be managed and distributed observing NIH and IRB policies on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being de-identified and properly revised for quality control by contacting study investigators.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 1-year
Access Criteria: The requested data will be shared with investigators via a secured, password-protected software website, upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Dyslipidemias
Obesity, Abdominal
Hypertriglyceridemia
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Hyperlipidemias