PILI 'Ohana Project: Partnerships to Overcome Obesity Disparities in Hawaii (3-Year Pilot)

Study Overview
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Brief Summary
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The PILI 'Ohana CBPR partnership implemented a pilot study to determine whether a Family plus Community focused intervention will improve weight loss maintenance compared to Standard follow-up in overweight/obese Native Hawaiian (NH) and other Pacific People (PP) adults (> 18 yr. old) after receiving a standard individual-focused behavioral intervention. The primary hypothesis was that overweight/obese NH and PP adults that undergo a combined family-focused plus community-focused intervention vs. a standard follow-up after receiving a standard individual-focused behavioral intervention will have significantly higher rates of weight loss maintenance.

Detailed Description
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The long term mission of the PILI 'Ohana Program is to integrate community wisdom and expertise with scientific methods to conduct research on health disparities with a specific emphasis on obesity in NHs and PPs. Recognizing that recent advances in medicine such as the reduction of cardiovascular disease mortality and the prevention of type 2 diabetes mellitus, have not translated into benefits for all sectors of the U.S. population, especially ethnic and racial minority populations, the PILI 'Ohana Program aims to address this gap through community-academic partnerships focused on interventions to promote change in obesity-related disparities in NH and PP communities. One of the scientific goals of the PILI 'Ohana Program focused on designing and implementing research activities aimed at completing a pilot intervention study to provide the basis for a more definitive, hypothesis-driven 5-year research study in the future.

Official Title
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Partnerships to Overcome Obesity Disparities in Hawaii

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: PILI 'Ohana Lifestyle Program
* Behavioral: Standard Behavioral Weight Loss Maintenance Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 behavioral weight loss intervention program that could potentially include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to induce weight loss of  1-2 lbs per week; Able to identify at least 2-3 family, friends or co-workers that 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 (16 months); 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.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family plus community focused intervention<br> | Behavioral: PILI 'Ohana Lifestyle Program<br>* 9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.<br>|
| Active Comparator: Standard Behavioral Weight Loss Maintenance Intervention<br> | Behavioral: Standard Behavioral Weight Loss Maintenance Program<br>* 9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight in kilograms (kg) |  | Baseline, 3-month follow-up, and 9-month follow-up | 
| Physical functioning measured by a 6-minute walk test |  | Baseline, 3-month follow-up, and 9-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Baseline, 3-month follow-up, and 9-month follow-up | 
| Change in dietary fat intake based on self-report |  | Baseline, 3-month follow-up, and 9-month follow-up | 
| Change in physical activity level based on self-report |  | Baseline, 3-month follow-up, and 9-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-blind, randomized controlled trial, Pilot study