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Completed

NCT Number: NCT01042886

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Native Hawaiian Health, University of Hawaii

Honolulu, Hawaii, 96813, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

PILI 'Ohana Lifestyle Program

Behavioral

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

Standard Behavioral Weight Loss Maintenance Program

Behavioral

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

Primary outcomes

  1. Weight in kilograms (kg)

    Time frame: Baseline, 3-month follow-up, and 9-month follow-up

  2. Physical functioning measured by a 6-minute walk test

    Time frame: Baseline, 3-month follow-up, and 9-month follow-up

Secondary outcomes

  1. Blood pressure

    Time frame: Baseline, 3-month follow-up, and 9-month follow-up

  2. Change in dietary fat intake based on self-report

    Time frame: Baseline, 3-month follow-up, and 9-month follow-up

  3. Change in physical activity level based on self-report

    Time frame: Baseline, 3-month follow-up, and 9-month follow-up

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Partnerships to Overcome Obesity Disparities in Hawaii

Acronym: PILI

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 6, 2010
Registry last updated
Jan 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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