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出境医 / 临床实验 / Culturally-Adapted Diet for Puerto Rican Adults

Culturally-Adapted Diet for Puerto Rican Adults

Study Description
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.
Study Design
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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, 2021
Estimated Study Completion Date : July 31, 2021
Arms and Interventions
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
Outcome Measures
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)


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • 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)
  • Change in levels of adipose risk factor [ Time Frame: 4 months ]
    Estimate the change in the value of waist circumference (cm)
  • 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)
  • Change in levels of metabolic risk factors [ Time Frame: 4 months ]
    Estimate the change in the value of glucose, HDL, and triglycerides (mg/dL)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Culturally-Adapted Diet for Puerto Rican Adults
Official Title  ICMJE Culturally-Adapted Diet for Puerto Rican Adults
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Obesity
  • Hypertension
  • Dyslipidemias
  • High Triglycerides
  • High Blood Glucose
  • Abdominal Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Culturally tailored food and diet advice
  • 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.
    Intervention: Behavioral: Standard healthy eating advice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Claudia Diaz, MPH 787-722-1248 ext 245 cbdiaz@fdipr.com
Contact: Michelle Echeandia, MS 787-722-1248 mecheandia@fdipr.com
Listed Location Countries  ICMJE Puerto Rico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975556
Other Study ID Numbers  ICMJE IRB19-0184
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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.
Responsible Party Josiemer Mattei, Harvard School of Public Health
Study Sponsor  ICMJE Harvard School of Public Health
Collaborators  ICMJE FDI Clinical Research
Investigators  ICMJE
Study Director: Jose F Rodriguez Orengo, PhD FDI Clinical Research
Principal Investigator: Josiemer Mattei, PhD, MPH Harvard Chan School of Public Health
PRS Account Harvard School of Public Health
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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