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

NCT ID: NCT01042886

Last Updated: 2010-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Family plus community focused intervention

Group Type EXPERIMENTAL

PILI 'Ohana Lifestyle Program

Intervention Type BEHAVIORAL

9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.

Standard Behavioral Weight Loss Maintenance Intervention

Group Type ACTIVE_COMPARATOR

Standard Behavioral Weight Loss Maintenance Program

Intervention Type BEHAVIORAL

9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.

Interventions

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PILI 'Ohana Lifestyle Program

9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.

Intervention Type BEHAVIORAL

Standard Behavioral Weight Loss Maintenance Program

9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Hawaii

OTHER

Sponsor Role lead

Responsible Party

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Department of Native Hawaiian Health, University of Hawaii at Manoa

Principal Investigators

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Joseph K Kaholokula, PhD

Role: STUDY_DIRECTOR

University of Hawaii at Manoa

Marjorie K Mau, MD

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii at Manoa

Locations

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Department of Native Hawaiian Health, University of Hawaii

Honolulu, Hawaii, United States

Site Status

Countries

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United States

References

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Kaholokula JK, Townsend CK, Ige A, Sinclair Ki, Mau MK, Leake A, Palakiko DM, Yoshimura SR, Kekauoha P, Hughes C. Sociodemographic, behavioral, and biological variables related to weight loss in native Hawaiians and other Pacific Islanders. Obesity (Silver Spring). 2013 Mar;21(3):E196-203. doi: 10.1002/oby.20038.

Reference Type DERIVED
PMID: 23404724 (View on PubMed)

Sinclair KA, Makahi EK, Shea-Solatorio C, Yoshimura SR, Townsend CK, Kaholokula JK. Outcomes from a diabetes self-management intervention for Native Hawaiians and Pacific People: Partners in Care. Ann Behav Med. 2013 Feb;45(1):24-32. doi: 10.1007/s12160-012-9422-1.

Reference Type DERIVED
PMID: 23086589 (View on PubMed)

Kaholokula JK, Mau MK, Efird JT, Leake A, West M, Palakiko DM, Yoshimura SR, Kekauoha BP, Rose C, Gomes H. A family and community focused lifestyle program prevents weight regain in Pacific Islanders: a pilot randomized controlled trial. Health Educ Behav. 2012 Aug;39(4):386-95. doi: 10.1177/1090198110394174. Epub 2011 May 6.

Reference Type DERIVED
PMID: 21551421 (View on PubMed)

Other Identifiers

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R24MD001660

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R24MD001660-03

Identifier Type: NIH

Identifier Source: org_study_id

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