Clinical trial NCT01093924: Partnerships to Overcome Obesity Disparities in Hawaii: 18-month CBPR Study
Official title: Partnerships to Overcome Obesity Disparities in Hawaii
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Behavioral weight loss maintenance intervention
Weight loss
Weight loss maintenance
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2010-03-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.).

Primary outcomes:
measure: Weight loss
timeFrame: 18-months
Secondary outcomes:
measure: Systolic/diastolic blood pressure
timeFrame: 18-months
measure: Self-reported dietary fat intake
timeFrame: 18-months
measure: Self-reported physical activity
timeFrame: 18-months
measure: Physical functioning
timeFrame: 18-month
measure: Self-reported health beliefs
timeFrame: 18-month
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Hawaii Maoli
state: Hawaii
city: Honolulu
country: United States
facility: Ke Ola Mamo
state: Hawaii
city: Honolulu
country: United States
facility: Kula no na Po'e Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: Kokua Kalihi Valley
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Joseph K Kaholokula, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sinclair KA, Zamora-Kapoor A, Townsend-Ing C, McElfish PA, Kaholokula JK. Implementation outcomes of a culturally adapted diabetes self-management education intervention for Native Hawaiians and Pacific islanders. BMC Public Health. 2020 Oct 20;20(1):1579. doi: 10.1186/s12889-020-09690-6.
citation: Sinclair KA, Makahi EK, Shea-Solatorio C, Yoshimura SR, Townsend CK, Kaholokula JK. Outcomes from a diabetes self-management intervention for Native Hawaiians and Pacific People: Partners in Care. Ann Behav Med. 2013 Feb;45(1):24-32. doi: 10.1007/s12160-012-9422-1.