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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Hawaii
ClinicalTrials.gov Identifier:
NCT01093924
First received: March 17, 2010
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Obesity
Behavioral: PILI 'Ohana 18-month weight loss maintenance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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 loss [ Time Frame: 18-months ] [ Designated as safety issue: No ]
    Amount of Weight loss in kilograms from baseline to 18 month follow-up


Secondary Outcome Measures:
  • Systolic/diastolic blood pressure [ Time Frame: 18-months ] [ Designated as safety issue: No ]
    Systolic/diastolic blood pressure (mmHg) as measured by an electronic blood pressure device

  • Self-reported dietary fat intake [ Time Frame: 18-months ] [ Designated as safety issue: No ]
    Self-reported dietary fat intake using an 18-item Food Frequency Questionnaire

  • Self-reported physical activity [ Time Frame: 18-months ] [ Designated as safety issue: No ]
    Self-reported physical activity frequency and intensity using a 3-item brief physical activity questionnaire

  • Physical functioning [ Time Frame: 18-month ] [ Designated as safety issue: No ]
    Physical functioning as measured by distance walked in feet via a 6-minunte Walk Test

  • Self-reported health beliefs [ Time Frame: 18-month ] [ Designated as safety issue: No ]
    Self-reported health beliefs associated with diet, physical activity, and weight using a standardized questionnaire


Enrollment: 240
Study Start Date: October 2009
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: self-guided weight loss maintenance
15-month self-guided weight loss maintenance group will receive monthly reminders to maintain their weight loss and newsletters that contain health information.
Experimental: DVD group
15-month weight loss maintenance intervention deliver via DVD.
Behavioral: PILI 'Ohana 18-month weight loss maintenance
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 Name: PILI 'Ohana Partnership
Experimental: face-to-face group
15-month weight loss/weight loss maintenance intervention delivered in a group setting
Behavioral: PILI 'Ohana 18-month weight loss maintenance
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 Name: PILI 'Ohana Partnership

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093924

Locations
United States, Hawaii
Kokua Kalihi Valley
Honolulu, Hawaii, United States, 96819
Kula no na Po'e Hawaii
Honolulu, Hawaii, United States, 96816
Hawaii Maoli
Honolulu, Hawaii, United States, 96807
Ke Ola Mamo
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
Investigators
Principal Investigator: Joseph K Kaholokula, PhD University of Hawaii
  More Information

Additional Information:
No publications provided by University of Hawaii

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT01093924     History of Changes
Other Study ID Numbers: PILI 'Ohana 5 year, R24MD001660-04
Study First Received: March 17, 2010
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Hawaii:
Behavioral weight loss maintenance intervention
Weight loss
Weight loss maintenance

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

ClinicalTrials.gov processed this record on April 17, 2014