PILI 'Ohana Project: Partnerships to Overcome Obesity Disparities in Hawaii (3-Year Pilot) (PILI)

January 4, 2010 updated by: University of Hawaii

Partnerships to Overcome Obesity Disparities in Hawaii

The PILI 'Ohana CBPR partnership implemented a pilot study to determine whether a Family plus Community focused intervention will improve weight loss maintenance compared to Standard follow-up in overweight/obese Native Hawaiian (NH) and other Pacific People (PP) adults (> 18 yr. old) after receiving a standard individual-focused behavioral intervention. The primary hypothesis was that overweight/obese NH and PP adults that undergo a combined family-focused plus community-focused intervention vs. a standard follow-up after receiving a standard individual-focused behavioral intervention will have significantly higher rates of weight loss maintenance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The long term mission of the PILI 'Ohana Program is to integrate community wisdom and expertise with scientific methods to conduct research on health disparities with a specific emphasis on obesity in NHs and PPs. Recognizing that recent advances in medicine such as the reduction of cardiovascular disease mortality and the prevention of type 2 diabetes mellitus, have not translated into benefits for all sectors of the U.S. population, especially ethnic and racial minority populations, the PILI 'Ohana Program aims to address this gap through community-academic partnerships focused on interventions to promote change in obesity-related disparities in NH and PP communities. One of the scientific goals of the PILI 'Ohana Program focused on designing and implementing research activities aimed at completing a pilot intervention study to provide the basis for a more definitive, hypothesis-driven 5-year research study in the future.

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Department of Native Hawaiian Health, University of Hawaii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 behavioral weight loss intervention program that could potentially include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to induce weight loss of ~1-2 lbs per week;
  • Able to identify at least 2-3 family, friends or co-workers that 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 (16 months);
  • 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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family plus community focused intervention
Behavioral: PILI 'Ohana Lifestyle Program
9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.
Active Comparator: Standard Behavioral Weight Loss Maintenance Intervention
Behavioral: Standard Behavioral Weight Loss Maintenance Program
9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight in kilograms (kg)
Time Frame: Baseline, 3-month follow-up, and 9-month follow-up
Baseline, 3-month follow-up, and 9-month follow-up
Physical functioning measured by a 6-minute walk test
Time Frame: Baseline, 3-month follow-up, and 9-month follow-up
Baseline, 3-month follow-up, and 9-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: Baseline, 3-month follow-up, and 9-month follow-up
Baseline, 3-month follow-up, and 9-month follow-up
Change in dietary fat intake based on self-report
Time Frame: Baseline, 3-month follow-up, and 9-month follow-up
Baseline, 3-month follow-up, and 9-month follow-up
Change in physical activity level based on self-report
Time Frame: Baseline, 3-month follow-up, and 9-month follow-up
Baseline, 3-month follow-up, and 9-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hawaii

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Study Director: Joseph K Kaholokula, PhD, University of Hawaii At Manoa
  • Principal Investigator: Marjorie K Mau, MD, University of Hawaii At Manoa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 4, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R24MD001660-03 (U.S. NIH Grant/Contract)
  • R24MD001660 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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