Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project

April 30, 2018 updated by: Joseph Keawe'aimoku Kaholokula, University of Hawaii

The purpose of the OHA PILI 'Ohana Project is to disseminate and evaluate the effectiveness of a community-based intervention (PILI 'Ohana Intervention Program) aimed at eliminating obesity in Pacific Peoples across the four islands. Dissemination will involve implementation of the program in eight communities through partnerships with nine different community-based organizations serving those areas (four founding community partners and five new community partners). These organizations provide services to a large number of Pacific Peoples, including (but not limited to) Native Hawaiians, Samoans, Filipinos, and Chuukese.

The main aims are to: (1) train five additional community organizations and their staff to deliver the PILI 'Ohana Intervention Program, (2) to enroll 150 overweight/obese participants across 8 different communities and four different islands into the intervention program, and (3) to evaluate the effectiveness of the program in reducing weight/BMI by at least 3% of the participant's initial weight.

The PILI 'Ohana Intervention is a 9-month lifestyle intervention focusing on individual health behaviors in the context of family and community environments and in the socio-cultural context of Pacific Peoples. In order to increase the likelihood that an organization will implement the PLP, they will be able to adapt the intervention and participant assessments. The POP will provide guidance on adaption of the intervention and assessments at the training (CHS #21680). What is described below is the maximum amount of contact and assessment procedures that participants will undergo. Therefore, organizations may change the timing of the 14 lessons and refrain from using all the assessment procedures, but will still provide the 14 lessons and offer the same incentives to participants for assessments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

335

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Department of Native Hawaiian Health, University of Hawaii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI greater than or equal to 25
  • Clients and/or residents of communities served by 9 partnering community organizations

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PILI Lifestyle Program
A 12-week Individual-focused Behavioral Weight Loss Intervention. Our 12-week intervention is modeled after the Diabetes Prevention Program's (DPP) Lifestyle Intervention. Each of the 8 lessons of this 12-week intervention will be done in a group classroom setting via trained community peer educators for a total of 8 group meetings as outlined above. Lesson 1 through 4 will be done every week, once a week, for 4 weeks followed by every other week for the remaining 4 lessons (lessons 5 through 8). Each group meeting will have between 12 to 15 people and take 1 to 1 ½ hours to complete. After completing the 12-week behavioral weight loss intervention, participants will participate in an additional 6 lessons. A lesson will be done once-a-month. These 6 lessons will teach participants how to involve their family and friends in their healthy lifestyle changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 9 months
Weight at 9 months compared to baseline
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 19, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MD001660

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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