OverweightPILINCT01042886
PILI 'Ohana Project: Partnerships to Overcome Obesity Disparities in Hawaii (3-Year Pilot)
A study testing PILI 'Ohana Lifestyle Program and Standard Behavioral Weight Loss Maintenance Program in people with Overweight and Obesity, run by University of Hawaii at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- PILI 'Ohana Lifestyle Program and Standard Behavioral Weight Loss Maintenance Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jul 2008
- 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
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Native Hawaiian Health, University of Hawaii
Honolulu, Hawaii, 96813
About this study
Official title: Partnerships to Overcome Obesity Disparities in Hawaii
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.
Read the detailed description
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.
- Conditions
- Overweight, Obesity
- Being tested
- PILI 'Ohana Lifestyle Program, Standard Behavioral Weight Loss Maintenance Program
- Keywords
- Non-blind, randomized controlled trial, Pilot study
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PILI 'Ohana Lifestyle ProgramBehavioural
9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports.
Standard Behavioral Weight Loss Maintenance ProgramBehavioural
9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies.
| Study group | Role | What they receive |
|---|---|---|
| Family plus community focused intervention | Experimental | Not described Receives: Behavioral: PILI 'Ohana Lifestyle Program |
| Standard Behavioral Weight Loss Maintenance Intervention | Active comparator | Not described Receives: Behavioral: Standard Behavioral Weight Loss Maintenance Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in kilograms (kg)
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Physical functioning measured by a 6-minute walk test
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Secondary outcomes (3)
Blood pressure
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Change in dietary fat intake based on self-report
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Change in physical activity level based on self-report
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startFeb 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Investigators
- Joseph K Kaholokula, PhD, Study director, University of Hawaii at ManoaMarjorie K Mau, MD, Principal investigator, University of Hawaii at Manoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042886
- Sponsor's protocol ID
- R24MD001660-03
- Other IDs
- R24MD001660
- Acronym
- PILI
- Status last verified
- Jan 2010
- First submitted
- 4 Jan 2010
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaholokula JK, Townsend CK, Ige A, Sinclair Ki, Mau MK, Leake A, Palakiko DM, Yoshimura SR, Kekauoha P, Hughes C. Sociodemographic, behavioral, and biological variables related to weight loss in native Hawaiians and other Pacific Islanders. Obesity (Silver Spring). 2013 Mar;21(3):E196-203. doi: 10.1002/oby.20038.
PubMed 23404724Sinclair 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.
PubMed 23086589Kaholokula JK, Mau MK, Efird JT, Leake A, West M, Palakiko DM, Yoshimura SR, Kekauoha BP, Rose C, Gomes H. A family and community focused lifestyle program prevents weight regain in Pacific Islanders: a pilot randomized controlled trial. Health Educ Behav. 2012 Aug;39(4):386-95. doi: 10.1177/1090198110394174. Epub 2011 May 6.
PubMed 21551421
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnerships to Overcome Obesity Disparities in Hawaii
- ClinicalTrials.gov ID
- NCT01042886
- Acronym / sponsor ID
- PILI / R24MD001660-03
- Conditions
- Overweight, Obesity
- Keywords
- Non-blind, randomized controlled trial, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Feb 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Jan 2010 (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 '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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family plus community focused intervention | Experimental | Behavioral: PILI 'Ohana Lifestyle Program |
| Standard Behavioral Weight Loss Maintenance Intervention | Active comparator | Behavioral: Standard Behavioral Weight Loss Maintenance Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.).
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 |
|---|---|---|
| PILI 'Ohana Lifestyle Program9-month weight loss and weight loss maintenance intervention focusing on family and community resources/supports. | Behavioural | Family plus community focused intervention |
| Standard Behavioral Weight Loss Maintenance Program9-month weight loss and weight loss maintenance intervention based on empirically-supported behavioral foci and strategies. | Behavioural | Standard Behavioral Weight Loss Maintenance Intervention |
Primary outcome
Weight in kilograms (kg)
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
Physical functioning measured by a 6-minute walk test
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
3 secondary outcomes
Blood pressure
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
Change in dietary fat intake based on self-report
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
Change in physical activity level based on self-report
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
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 6 Jan 2010.
- Derived from this study: PubMed 23404724Kaholokula JK, Townsend CK, Ige A, Sinclair Ki, Mau MK, Leake A, Palakiko DM, Yoshimura SR, Kekauoha P, Hughes C. Sociodemographic, behavioral, and biological variables related to weight loss in native Hawaiians and other Pacific Islanders. Obesity (Silver Spring). 2013 Mar;21(3):E196-203. doi: 10.1002/oby.20038.
- Derived from this study: PubMed 23086589Sinclair 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.
- Derived from this study: PubMed 21551421Kaholokula JK, Mau MK, Efird JT, Leake A, West M, Palakiko DM, Yoshimura SR, Kekauoha BP, Rose C, Gomes H. A family and community focused lifestyle program prevents weight regain in Pacific Islanders: a pilot randomized controlled trial. Health Educ Behav. 2012 Aug;39(4):386-95. doi: 10.1177/1090198110394174. Epub 2011 May 6.
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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 study director
University of Hawaii at Manoa
Marjorie K Mau, MD principal investigator
University of Hawaii at Manoa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PILI 'Ohana Lifestyle Program and Standard Behavioral Weight Loss Maintenance Program in people with Overweight and Obesity, run by University of Hawaii at 1 site 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 5 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 6 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Weight in kilograms (kg) (time frame: Baseline, 3-month follow-up, and 9-month follow-up). 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?
On the ClinicalTrials.gov record for NCT01042886, which also lists 3 linked publications.
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 6 Jan 2010.