PILI at Work a 5-Year Controlled Intervention Trial: Testing DVD Versus Group Delivery of a Weight-Loss Maintenance Intervention in Native Hawaiian- Serving Worksites



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2010
End Date:May 2015

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5-Year Controlled Intervention Trial: Testing DVD Versus Group Delivery of a Weight-Loss Maintenance Intervention in Native Hawaiian- Serving Worksites

The PILI @ Work project is a 5 year randomized control trial to adapt a weight loss program
for the employees of Native Hawaiian-serving organizations in Hawai'i. The study has two
specific aims:

Specific Aim 1: To adapt and implement a weight loss and weight loss maintenance program in
Native Hawaiian-serving organizations, working with employee representatives to determine
how the intervention can be best implemented with employees at the worksites. Specific Aim
2: Among employees participating in the program, to test whether weight loss maintenance
program in DVD format is as effective as the weight loss maintenance program in a group face
to face format in maintaining weight loss for employees who complete weight loss program.

The investigators hypothesize that the PILI @ Work interventions can be effectively adapted
and implemented in a worksite settings with active participation by employees and employers.
The investigators also hypothesize that overweight (BMI ≥ 25) and obese (BMI ≥ 30) employees
who complete weight loss portion of the intervention, and are randomized to received the
weight loss maintenance intervention via DVD will have similar success at maintaining weight
loss compared to those randomized to PILI Maintenance in group meetings or settings. The
investigators hypothesize that will will also be true for physical functioning,blood
pressure, daily self-weighing, low to moderate fat and low calorie diets, and daily physical
activity.

Effective and culturally relevant interventions are needed to curb the rising tide of
overweight and obesity. This study adapts an evidence-based weight loss intervention for use
in Native Hawaiian-serving organizations in Hawai'i, using a community-based participatory
research (CBPR) approach. Findings from our two previous NIH-funded projects help to inform
this proposed research: 1) The Designing Healthy Worksites (DHW) Project and 2) the PILI
Lifestyle Intervention (PILI), developed by the PILI 'Ohana (family) Project: Partnerships
to Overcome Obesity Disparities in Hawai'i.

The DHW Project engaged with eight Native Hawaiian-serving organizations to obtain data on
1) existing worksite policies that support and/or promote health and well-being of employees
and 2) the perspectives and ideas of employees and employers around creating a healthy
workplace. DHW participants expressed enthusiasm for health promotion programs at the
worksite, especially weight-loss programs.

The PILI 'Ohana Project adapted an evidence-based lifestyle intervention for use with Native
Hawaiians and Pacific Islanders who sought care at community health clinics and/or were
members of civic groups. The PILI Lifestyle Intervention (PILI) has two phases—PILI Weight
Loss and PILI Maintenance. Both PILI Wt Loss and PILI Maintenance were designed for deliver
to community-based groups. In pilot testing, all participants participating in PILI Wt Loss
and realized significant weight loss after 3 months. Participants then were randomized into
PILI Maintenance or standard behavioral treatment (SBT); those in PILI Maintenance performed
better than those in SBT. PILI Wt Loss and PILI Maintenance were improved based on feedback
from the pilot. Because of reported time constraints by pilot participants, a DVD version of
PILI Maintenance was developed that people could use instead of attending group sessions. In
a subsequent community-based study of PILI (funded by NIH-NCMHD and now underway),
non-worksite participants are being randomized into a face-to-face or DVD delivery of PILI
Maintenance after completion of PILI Wt Loss.

Our specific aims and hypotheses for its application in worksites are as follows:

Specific Aim 1: To adapt and implement PILI Wt Loss and PILI Maintenance in Native
Hawaiian-serving organizations, working with employee representatives to determine how the
intervention can be best implemented with employees in worksites (PILI Wt Loss and PILI
Maintenance together will be called PILI@Work).

Primary hypothesis: A community-tested, evidence-based intervention for obesity reduction
and weight-loss maintenance can be effectively adapted and implemented in worksite settings
with active participation by employees and employers.

Specific Aim 2: Among employees participating in PILI@Work, to test whether PILI Maintenance
in DVD format is as effective as PILI Maintenance in Group in maintaining weight loss for
employees who complete PILI Wt Loss.

Primary hypothesis: Overweight (BMI ≥ 25) and obese (BMI ≥ 30) employees who complete PILI
Wt Loss will have successful weight loss outcomes, and those randomized to PILI Maintenance
in DVD will have similar success at maintaining weight loss compared to those randomized to
PILI Maintenance in group meetings or settings. Successful weight loss maintenance will be
measured as a ≥ 3% mean weight change.

Secondary hypothesis: Employees participating in PILI Maintenance in DVD and those in PILI
Maintenance in Group will show similar maintenance of, or improvements in, physical
functioning, blood pressure, daily self-weighing, low to moderate fat and low calorie diets,
and daily physical activity.

Inclusion Criteria:

- persons of any self-reported ethnicity

- age 18 years or older

- overweight or obese as defined as (BMI) ≥ 25 for Caucasians, NHs, or PIs and > 23 for
those with Asian ancestry

- willing and able to follow a healthy eating and physical activity regimen that could
include 150 minutes of brisk walking per week (or equivalent) and caloric intake
control

Exclusion Criteria:

- prognosed survival < 6 months

- planning to terminate employment during the intervention study period (12 months)

- pregnancy

- any dietary or exercise restrictions that would prevent an individual from fully
participating in the intervention protocol (e.g., end-stage renal disease on a renal
diet)

- any co-morbid condition (physical and mental disabilities) that would prevent the
individual from participating in the intervention protocol (e.g., severe arthritis,
hemi-paresis, major psychiatric illness, eating disorder)
We found this trial at
8
sites
Kailua-Kona, Hawaii 96740
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Honolulu, Hawaii 96813
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Honolulu, HI
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Honolulu, Hawaii 96819
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Honolulu, Hawaii 96817
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Honolulu, HI
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Kaunakakai, Hawaii 96748
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Kaunakakai, HI
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