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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Hawaii
ClinicalTrials.gov Identifier:
NCT01042886
First received: January 4, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 4, 2010
January 4, 2010
February 2007
July 2008   (final data collection date for primary outcome measure)
  • Weight in kilograms (kg) [ Time Frame: Baseline, 3-month follow-up, and 9-month follow-up ] [ Designated as safety issue: No ]
  • Physical functioning measured by a 6-minute walk test [ Time Frame: Baseline, 3-month follow-up, and 9-month follow-up ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Blood pressure [ Time Frame: Baseline, 3-month follow-up, and 9-month follow-up ] [ Designated as safety issue: No ]
  • Change in dietary fat intake based on self-report [ Time Frame: Baseline, 3-month follow-up, and 9-month follow-up ] [ Designated as safety issue: No ]
  • Change in physical activity level based on self-report [ Time Frame: Baseline, 3-month follow-up, and 9-month follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
PILI 'Ohana Project: Partnerships to Overcome Obesity Disparities in Hawaii (3-Year Pilot)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Overweight
  • Obesity
  • Behavioral: PILI 'Ohana Lifestyle Program
    9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.
  • Behavioral: Standard Behavioral Weight Loss Maintenance Program
    9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.
  • Experimental: Family plus community focused intervention
    Intervention: Behavioral: PILI 'Ohana Lifestyle Program
  • Active Comparator: Standard Behavioral Weight Loss Maintenance Intervention
    Intervention: Behavioral: Standard Behavioral Weight Loss Maintenance Program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
277
July 2008
July 2008   (final data collection date for primary outcome measure)

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.).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01042886
R24MD001660-03, R24MD001660
Yes
Marjorie K. Mau/Principal Investigator, Department of Native Hawaiian Health, University of Hawaii at Manoa
University of Hawaii
National Center on Minority Health and Health Disparities (NCMHD)
Study Director: Joseph K Kaholokula, PhD University of Hawaii at Manoa
Principal Investigator: Marjorie K Mau, MD University of Hawaii at Manoa
University of Hawaii
January 2010

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