Skip to main content
OpenTrials
Completed

NCT Number: NCT02320331

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

PILI Lifestyle Program

Behavioral

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.

Primary outcomes

  1. Weight loss

    Time frame: 9 months

    Weight at 9 months compared to baseline

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • Hawai'i Maoli
  • Ke Ola Mamo
  • Kokua Kalihi Valley
  • Kula No Na Po'e Hawaii

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2014
Registry last updated
May 2, 2018

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.

Published trials that share one or more normalized conditions with this study.