Back to resultsPILI 'Ohana Project: Partnerships to Overcome Obesity Disparities in Hawaii (3-Year Pilot) (PILI)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PILI 'Ohana Lifestyle Program
Standard Behavioral Weight Loss Maintenance Program
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Non-blind, randomized controlled trial, Pilot study
Eligibility Criteria
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.).
Sites / Locations
- Department of Native Hawaiian Health, University of Hawaii
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Family plus community focused intervention
Standard Behavioral Weight Loss Maintenance Intervention
Arm Description
Outcomes
Primary Outcome Measures
Weight in kilograms (kg)
Physical functioning measured by a 6-minute walk test
Secondary Outcome Measures
Blood pressure
Change in dietary fat intake based on self-report
Change in physical activity level based on self-report
Full Information
NCT ID
NCT01042886
First Posted
January 4, 2010
Last Updated
January 4, 2010
Sponsor
University of Hawaii
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT01042886
Brief Title
PILI 'Ohana Project: Partnerships to Overcome Obesity Disparities in Hawaii (3-Year Pilot)
Acronym
PILI
Official Title
Partnerships to Overcome Obesity Disparities in Hawaii
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Hawaii
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Non-blind, randomized controlled trial, Pilot study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
277 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family plus community focused intervention
Arm Type
Experimental
Arm Title
Standard Behavioral Weight Loss Maintenance Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
PILI 'Ohana Lifestyle Program
Intervention Description
9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.
Intervention Type
Behavioral
Intervention Name(s)
Standard Behavioral Weight Loss Maintenance Program
Intervention Description
9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.
Primary Outcome Measure Information:
Title
Weight in kilograms (kg)
Time Frame
Baseline, 3-month follow-up, and 9-month follow-up
Title
Physical functioning measured by a 6-minute walk test
Time Frame
Baseline, 3-month follow-up, and 9-month follow-up
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
Baseline, 3-month follow-up, and 9-month follow-up
Title
Change in dietary fat intake based on self-report
Time Frame
Baseline, 3-month follow-up, and 9-month follow-up
Title
Change in physical activity level based on self-report
Time Frame
Baseline, 3-month follow-up, and 9-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph K Kaholokula, PhD
Organizational Affiliation
University of Hawaii at Manoa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marjorie K Mau, MD
Organizational Affiliation
University of Hawaii at Manoa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Native Hawaiian Health, University of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23404724
Citation
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.
Results Reference
derived
PubMed Identifier
23086589
Citation
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.
Results Reference
derived
PubMed Identifier
21551421
Citation
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.
Results Reference
derived
Learn more about this trial
PILI 'Ohana Project: Partnerships to Overcome Obesity Disparities in Hawaii (3-Year Pilot)
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