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Completed

NCT Number: NCT01093924

Partnerships to Overcome Obesity Disparities in Hawaii: 18-month CBPR Study

This is a 5-year community-based participatory research intervention study with the goals of 1) conducting a more definitive study of weight loss maintenance in Native Hawaiians and Pacific Peoples and 2) identifying the aspects of the community-academic partnership that fosters a co-learning and co-equal environment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hawaii Maoli, Honolulu, Hawaii, United States

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About this study

Obesity and overweight are well recognized public health concerns in the US and the magnitude of excess weight is greater among racial/ethnic minority populations. For NHs and PPs 70 to 80% of adults are estimated to be overweight or obese. Obesity-related disparities such as diabetes and heart disease (CVD) are also increasing among NHs and PPs. To address obesity and related disparities, a community-based participatory research (CBPR) partnership was formed entitled, the Partnership for Improving Lifestyle Interventions (PILI) 'Ohana Program (Pili meaning relationship and 'Ohana meaning family). The PILI 'Ohana Program (POP) consists of 5 community organizations and the Department of Native Hawaiian Health (DNHH) at the John A. Burns School of Medicine (JABSOM) of the University of Hawai'i (UH). With a 3-year CBPR planning grant from the National Center on Minority Health and Health Disparities (NCMHD), the POP was successful at establishing this community-academic partnership aimed at obesity-related disparities in Hawai'i and in implementing a pilot intervention to address weight loss maintenance (the PILI 'Ohana Intervention) in NHs and PPs, which serves as preliminary data for this application. The specific aims are as follow: 1) To identify the aspects of the PILI 'Ohana (family + community focused) Intervention deemed effective by former participants and community-peer educators of the pilot intervention. 2) To test whether a face-to-face or DVD delivery method of the PILI 'Ohana intervention is effective in improving weight loss maintenance versus a control group in NHs and PPs. 3) To identify the strengths of the PILI 'Ohana Program that supports a co-learning and co-equal environment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Self-reported 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 weight loss maintenance intervention program that could include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to maintain weight loss
  • Able to identify at least one family, friend, or co-worker who 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
  • 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 18-month weight loss maintenance

Behavioral

All participants will receive a 8 lesson 3-month weight loss intervention. They will then be randomized. Those continuing with the intervention will receive 17 more lessons delivered face-to-face or via DVD over 15 months for a total of 18 months. Each lesson lasts approximately 1 hour and helps participants integrate healthy eating and physical activity into their lifestyles. Participants will also be encouraged to attend 13 community activities during the last 13 months of the intervention.

Other names: PILI 'Ohana Partnership

Primary outcomes

  1. Weight loss

    Time frame: 18-months

    Amount of Weight loss in kilograms from baseline to 18 month follow-up

Secondary outcomes

  1. Systolic/diastolic blood pressure

    Time frame: 18-months

    Systolic/diastolic blood pressure (mmHg) as measured by an electronic blood pressure device

  2. Self-reported dietary fat intake

    Time frame: 18-months

    Self-reported dietary fat intake using an 18-item Food Frequency Questionnaire

  3. Self-reported physical activity

    Time frame: 18-months

    Self-reported physical activity frequency and intensity using a 3-item brief physical activity questionnaire

  4. Physical functioning

    Time frame: 18-month

    Physical functioning as measured by distance walked in feet via a 6-minunte Walk Test

  5. Self-reported health beliefs

    Time frame: 18-month

    Self-reported health beliefs associated with diet, physical activity, and weight using a standardized questionnaire

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Mar 26, 2010
Registry last updated
Nov 15, 2013

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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