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
P@W
5-Year Controlled Intervention Trial: Testing DVD Versus Group Delivery of a Weight-Loss Maintenance Intervention in Native Hawaiian- Serving Worksites
1 other identifier
interventional
200
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Sep 2010
Longer than P75 for not_applicable obesity
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 23, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedDecember 2, 2015
July 1, 2012
4.6 years
July 23, 2012
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in weight from baseline to 3-month and 12-month follow up
Change in weight from baseline to 3-month and 12-month follow up.
baseline, 3-months, 12-months
Change in physical functioning from baseline to 3-month and 12-month follow up
Change in number of feet walked in 6 minutes from baseline to 3-month and 12-month follow up.
baseline, 3-months, 12-months
Secondary Outcomes (3)
Blood pressure
baseline, 3-months, 12-months
Physical Activity Frequency
baseline, 3-months, 12-month
Fat in Diet
baseline, 3-months, 12-months
Study Arms (2)
Weight loss maintenance intervention delivered via DVD
EXPERIMENTALWeight loss maintenance intervention delivered via DVD (without a peer facilitator) to employee participants within the respective worksites randomized to this arm. Using DVD technology, a total of 11 additional sessions (designed for weight loss maintenance) over a 9-month period will be delivered to the participants of this arm using DVD-produced lessons of PILI Maintenance
Weight loss maintenance intervention Face-to-Face
EXPERIMENTALThe PILI Maintenance delivered face-to-face in a group setting by trained peer facilitators to employee participants within the respective worksites randomized to this arm. The trained peer facilitator will deliver a total of 11 additional sessions (designed for weight loss maintenance) over a 9-month period, meeting bi-weekly for the first 2 months and then monthly for the remaining 7 months with a group of 8 to 15 participants.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Hawaiilead
- Queen's Medical Centercollaborator
- I Ola Lahui, Inc.collaborator
- Queen Lili'uokalani Children's Centercollaborator
- Ke Ola Mamocollaborator
- Molokai Community Health Centercollaborator
- Keiki o ka Ainacollaborator
Study Sites (8)
I Ola Lahui
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii, John A Burns School of Medicine
Honolulu, Hawaii, 96813, United States
Ke Ola Mamo, Native Hawaiian Health Care System
Honolulu, Hawaii, 96817, United States
Queen Liliuokalani Children's Center
Honolulu, Hawaii, 96817, United States
Keiki o ka Aina
Honolulu, Hawaii, 96819, United States
Queen Liliuokalani Children's Center
Kailua-Kona, Hawaii, 96740, United States
Molokai Community Health Center
Kaunakakai, Hawaii, 96748, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph K Kaholokula, PhD
University of Hawaii at Manoa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2012
First Posted
July 30, 2012
Study Start
September 1, 2010
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
December 2, 2015
Record last verified: 2012-07