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Partnerships to Overcome Obesity Disparities in Hawaii: 18-month CBPR Study

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ClinicalTrials.gov Identifier: NCT01093924
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : November 15, 2013
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
University of Hawaii

Tracking Information
First Submitted Date  ICMJE March 17, 2010
First Posted Date  ICMJE March 26, 2010
Last Update Posted Date November 15, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
Weight loss [ Time Frame: 18-months ]
Amount of Weight loss in kilograms from baseline to 18 month follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
  • Systolic/diastolic blood pressure [ Time Frame: 18-months ]
    Systolic/diastolic blood pressure (mmHg) as measured by an electronic blood pressure device
  • Self-reported dietary fat intake [ Time Frame: 18-months ]
    Self-reported dietary fat intake using an 18-item Food Frequency Questionnaire
  • Self-reported physical activity [ Time Frame: 18-months ]
    Self-reported physical activity frequency and intensity using a 3-item brief physical activity questionnaire
  • Physical functioning [ Time Frame: 18-month ]
    Physical functioning as measured by distance walked in feet via a 6-minunte Walk Test
  • Self-reported health beliefs [ Time Frame: 18-month ]
    Self-reported health beliefs associated with diet, physical activity, and weight using a standardized questionnaire
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 Partnerships to Overcome Obesity Disparities in Hawaii: 18-month CBPR Study
Official Title  ICMJE Partnerships to Overcome Obesity Disparities in Hawaii
Brief Summary This is a 5-year community-based participatory research intervention study with the goals of 1) conducting a more definitive study of weight loss maintenance in Native Hawaiians and Pacific Peoples and 2) identifying the aspects of the community-academic partnership that fosters a co-learning and co-equal environment.
Detailed Description Obesity and overweight are well recognized public health concerns in the US and the magnitude of excess weight is greater among racial/ethnic minority populations. For NHs and PPs 70 to 80% of adults are estimated to be overweight or obese. Obesity-related disparities such as diabetes and heart disease (CVD) are also increasing among NHs and PPs. To address obesity and related disparities, a community-based participatory research (CBPR) partnership was formed entitled, the Partnership for Improving Lifestyle Interventions (PILI) 'Ohana Program (Pili meaning relationship and 'Ohana meaning family). The PILI 'Ohana Program (POP) consists of 5 community organizations and the Department of Native Hawaiian Health (DNHH) at the John A. Burns School of Medicine (JABSOM) of the University of Hawai'i (UH). With a 3-year CBPR planning grant from the National Center on Minority Health and Health Disparities (NCMHD), the POP was successful at establishing this community-academic partnership aimed at obesity-related disparities in Hawai'i and in implementing a pilot intervention to address weight loss maintenance (the PILI 'Ohana Intervention) in NHs and PPs, which serves as preliminary data for this application. The specific aims are as follow: 1) To identify the aspects of the PILI 'Ohana (family + community focused) Intervention deemed effective by former participants and community-peer educators of the pilot intervention. 2) To test whether a face-to-face or DVD delivery method of the PILI 'Ohana intervention is effective in improving weight loss maintenance versus a control group in NHs and PPs. 3) To identify the strengths of the PILI 'Ohana Program that supports a co-learning and co-equal environment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: PILI 'Ohana 18-month weight loss maintenance
All participants will receive a 8 lesson 3-month weight loss intervention. They will then be randomized. Those continuing with the intervention will receive 17 more lessons delivered face-to-face or via DVD over 15 months for a total of 18 months. Each lesson lasts approximately 1 hour and helps participants integrate healthy eating and physical activity into their lifestyles. Participants will also be encouraged to attend 13 community activities during the last 13 months of the intervention.
Other Name: PILI 'Ohana Partnership
Study Arms  ICMJE
  • No Intervention: self-guided weight loss maintenance
    15-month self-guided weight loss maintenance group will receive monthly reminders to maintain their weight loss and newsletters that contain health information.
  • Experimental: DVD group
    15-month weight loss maintenance intervention deliver via DVD.
    Intervention: Behavioral: PILI 'Ohana 18-month weight loss maintenance
  • Experimental: face-to-face group
    15-month weight loss/weight loss maintenance intervention delivered in a group setting
    Intervention: Behavioral: PILI 'Ohana 18-month weight loss maintenance
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2010)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background;
  • Age 18 years or older
  • Overweight or Obese defined as BMI > 25 kg/m2 (NH or Pacific Islanders) or > 23 kg/m2 (Filipino ethnic background)
  • Willing and able to follow a weight loss maintenance intervention program that could include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to maintain weight loss
  • Able to identify at least one family, friend, or co-worker who would be willing to support the participant during the course of the study

Exclusion Criteria:

  • Survival less than 6 months
  • Planning to move out of the community during the intervention study period
  • Pregnancy
  • Any dietary or exercise restrictions that would prevent an individual from fully participating in the intervention protocol (i.e., end-stage renal disease on a renal diet, etc.)
  • Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., severe arthritis, hemi-paresis, major psychiatric illness, eating disorders, etc.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01093924
Other Study ID Numbers  ICMJE PILI 'Ohana 5 year
R24MD001660-04 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Hawaii
Study Sponsor  ICMJE University of Hawaii
Collaborators  ICMJE National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Joseph K Kaholokula, PhD University of Hawaii
PRS Account University of Hawaii
Verification Date November 2013

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