ObesityP@WNCT01652989
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
A study testing Weight loss maintenance intervention face-to-face and Weight loss maintenance intervention delivered via DVD in people with Obesity and Overweight, run by University of Hawaii at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Weight loss maintenance intervention face-to-face and Weight loss maintenance intervention delivered via DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2010to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
I Ola Lahui
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
University of Hawaii, John A Burns School of Medicine
Honolulu, Hawaii, 96813
Ke Ola Mamo, Native Hawaiian Health Care System
Honolulu, Hawaii, 96817
Queen Liliuokalani Children's Center
Honolulu, Hawaii, 96817
Keiki o ka Aina
Honolulu, Hawaii, 96819
Queen Liliuokalani Children's Center
Kailua-Kona, Hawaii, 96740
Molokai Community Health Center
Kaunakakai, Hawaii, 96748
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Obesity, Overweight, Weight Loss, Weight Loss Maintenance
- Being tested
- Weight loss maintenance intervention face-to-face, Weight loss maintenance intervention delivered via DVD
- Keywords
- weight loss, weight loss maintenance, community based participatory research, overweight
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss maintenance intervention face-to-faceBehavioural
Weight loss maintenance intervention delivered via DVDBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Weight loss maintenance intervention delivered via DVD | Experimental | Weight 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 Receives: Behavioral: Weight loss maintenance intervention delivered via DVD |
| Weight loss maintenance intervention Face-to-Face | Experimental | The 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. Receives: Behavioral: Weight loss maintenance intervention face-to-face |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 3-months, 12-months
Secondary outcomes (3)
Blood pressure
Change in blood pressure from baseline to 3-month and 12-month follow up.
Measured: baseline, 3-months, 12-months
Physical Activity Frequency
Change in physical activity frequency from baseline to 3-month and 12-month follow up as measured by a brief 3-item questionnaire assessing frequency of moderate and vigorous physical activity over the last month.
Measured: baseline, 3-months, 12-month
Fat in Diet
Change in fat in diet from baseline to 3-month and 12-month follow up as measured by a 36-item questionnaire designed to measure the amount of fat in a participant's diet.
Measured: baseline, 3-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startSep 2010
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's Medical Center, I Ola Lahui, Inc., Queen Lili'uokalani Children's Center, Ke Ola Mamo, Molokai Community Health Center, Keiki o ka Aina
- Responsible party
- Sponsor
- Investigators
- Joseph K Kaholokula, PhD, Principal investigator, University of Hawaii at Manoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652989
- Sponsor's protocol ID
- 1U54CA153459
- Acronym
- P@W
- Status last verified
- Jul 2012
- First submitted
- 23 Jul 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-Year Controlled Intervention Trial: Testing DVD Versus Group Delivery of a Weight-Loss Maintenance Intervention in Native Hawaiian- Serving Worksites
- ClinicalTrials.gov ID
- NCT01652989
- Acronym / sponsor ID
- P@W / 1U54CA153459
- Conditions
- Obesity, Overweight, Weight Loss, Weight Loss Maintenance
- Keywords
- weight loss, weight loss maintenance, community based participatory research, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Queen's Medical Center, I Ola Lahui, Inc., Queen Lili'uokalani Children's Center, Ke Ola Mamo, Molokai Community Health Center, Keiki o ka Aina
- Study start
- Sep 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss maintenance intervention delivered via DVD | Experimental | Behavioral: Weight loss maintenance intervention delivered via DVDWeight 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 | Experimental | Behavioral: Weight loss maintenance intervention face-to-faceThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss maintenance intervention face-to-face | Behavioural | Weight loss maintenance intervention Face-to-Face |
| Weight loss maintenance intervention delivered via DVD | Behavioural | Weight loss maintenance intervention delivered via DVD |
Primary outcome
Change in weight from baseline to 3-month and 12-month follow up
Time frame: baseline, 3-months, 12-months
Change in weight from baseline to 3-month and 12-month follow up.
Change in physical functioning from baseline to 3-month and 12-month follow up
Time frame: baseline, 3-months, 12-months
Change in number of feet walked in 6 minutes from baseline to 3-month and 12-month follow up.
3 secondary outcomes
Blood pressure
Time frame: baseline, 3-months, 12-months
Physical Activity Frequency
Time frame: baseline, 3-months, 12-month
Fat in Diet
Time frame: baseline, 3-months, 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph K Kaholokula, PhD principal investigator
University of Hawaii at Manoa
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss maintenance intervention face-to-face and Weight loss maintenance intervention delivered via DVD in people with Obesity and Overweight, run by University of Hawaii at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight from baseline to 3-month and 12-month follow up (time frame: baseline, 3-months, 12-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.