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
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: PILI 'Ohana Lifestyle Program
Behavioral: Standard Behavioral Weight Loss Maintenance Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Partnerships to Overcome Obesity Disparities in Hawaii

Resource links provided by NLM:


Further study details as provided by University of Hawaii:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 277
Study Start Date: February 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042886

Locations
United States, Hawaii
Department of Native Hawaiian Health, University of Hawaii
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
Investigators
Study Director: Joseph K Kaholokula, PhD University of Hawaii at Manoa
Principal Investigator: Marjorie K Mau, MD University of Hawaii at Manoa
  More Information

No publications provided by University of Hawaii

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marjorie K. Mau/Principal Investigator, Department of Native Hawaiian Health, University of Hawaii at Manoa
ClinicalTrials.gov Identifier: NCT01042886     History of Changes
Other Study ID Numbers: R24MD001660-03, R24MD001660
Study First Received: January 4, 2010
Last Updated: January 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Hawaii:
Non-blind, randomized controlled trial
Pilot study

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014